search
Back to results

Falls Prevention Program for Adults With Osteoarthritis

Primary Purpose

Osteoarthritis, Falls, Accidental

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Otago Exercise Programme and Walk with Ease
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • history of falls
  • knee or hip radiographic OA
  • 65+ years of age
  • normal cognitive function (based on the Mini-Mental State Examination)
  • current knee/hip symptoms

Exclusion Criteria:

  • hospitalized for stroke, myocardial infarction, or coronary artery revascularization in past 3 months
  • diagnosis of metastatic cancer in the past 3 months
  • terminal illness
  • progressive neurological disorders
  • rheumatoid arthritis
  • severe fibromyalgia
  • other systemic rheumatic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm - Intervention

    Arm Description

    Receives Otago Exercise Programme and Walk with Ease

    Outcomes

    Primary Outcome Measures

    Participant Adherence to Intervention
    Number of participants who adhere to the intervention.
    Participant Safety With the Intervention
    Number and type of adverse events related to the intervention.
    Retention of Participants
    Number of participants who participate in the study for the full 6 month program.
    Acceptability of the Program
    Descriptive summary of participants' reports from closing interview of what they like and do not like about the program, any challenges they experienced with doing the program, and whether they plan to continue what they learned.

    Secondary Outcome Measures

    Number of Falls
    Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.
    Number of People With Severe of Falls
    Participant will record whether the fall resulted in an injury and the type of injury that occurred. A fall will be considered severe if an injury occurred.
    Berg Balance Scale
    This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
    Four-tests Balance: Feet Together Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Hand Grip Dynamometry Right Hand
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    30-second Chair Stand Test
    Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
    Timed Up and Go Test
    Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
    Stair Climb Test
    Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
    Western Ontario and McMaster Universities Osteoarthritis Index
    This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
    Activities-specific Balance Confidence Scale
    Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
    Rapid Assessment of Physical Activity: Aerobic Score
    Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: I rarely or never do any physical activities. Under-active: I do some light or moderate physical activities, but not every week. Under-active regular - light activities: I do some light physical activity every week. Under-active regular: I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
    Berg Balance Scale
    This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
    Berg Balance Scale
    This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
    Four-tests Balance: Feet Together Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Feet Together Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Semi-tandem Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Semi-tandem Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Semi-tandem Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Tandem Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Tandem Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: Tandem Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: One Leg Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: One Leg Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Four-tests Balance: One Leg Stand
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Hand Grip Dynamometry Right Hand
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Hand Grip Dynamometry Right Hand
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Hand Grip Dynamometry Left Hand
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Hand Grip Dynamometry Left Hand
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Hand Grip Dynamometry Left Hand
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    30-second Chair Stand Test
    Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
    30-second Chair Stand Test
    Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
    Timed Up and Go Test
    Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
    Timed Up and Go Test
    Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
    Stair Climb Test
    Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
    Stair Climb Test
    Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
    Western Ontario and McMaster Universities Osteoarthritis Index
    This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
    Western Ontario and McMaster Universities Osteoarthritis Index
    This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
    Activities-specific Balance Confidence Scale
    Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
    Activities-specific Balance Confidence Scale
    Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
    Rapid Assessment of Physical Activity: Aerobic Score
    Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: I rarely or never do any physical activities. Under-active: I do some light or moderate physical activities, but not every week. Under-active regular - light activities: I do some light physical activity every week. Under-active regular: I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
    Rapid Assessment of Physical Activity: Aerobic Score
    Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: I rarely or never do any physical activities. Under-active: I do some light or moderate physical activities, but not every week. Under-active regular - light activities: I do some light physical activity every week. Under-active regular: I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.

    Full Information

    First Posted
    November 2, 2015
    Last Updated
    February 6, 2018
    Sponsor
    University of North Carolina, Chapel Hill
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02648646
    Brief Title
    Falls Prevention Program for Adults With Osteoarthritis
    Official Title
    Falls Prevention Program for Adults With Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2, 2015 (Actual)
    Primary Completion Date
    October 31, 2016 (Actual)
    Study Completion Date
    October 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of North Carolina, Chapel Hill

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Purpose: To report the feasibility and to obtain preliminary data on the effects of using an enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis (OA). Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA, are at risk for falls, and are 65+ years old. Procedures (methods): All participants will receive the 6-month enhanced Otago program. The investigators will assemble data: quantifying participant adherence to and safety of the intervention, ascertaining retention of participants for 6 months, determining acceptability of the program, and other validated measures (e.g., number of falls and fall severity, balance measures).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Falls, Accidental

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm - Intervention
    Arm Type
    Experimental
    Arm Description
    Receives Otago Exercise Programme and Walk with Ease
    Intervention Type
    Other
    Intervention Name(s)
    Otago Exercise Programme and Walk with Ease
    Intervention Description
    The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
    Primary Outcome Measure Information:
    Title
    Participant Adherence to Intervention
    Description
    Number of participants who adhere to the intervention.
    Time Frame
    6 months
    Title
    Participant Safety With the Intervention
    Description
    Number and type of adverse events related to the intervention.
    Time Frame
    6 months
    Title
    Retention of Participants
    Description
    Number of participants who participate in the study for the full 6 month program.
    Time Frame
    6 months
    Title
    Acceptability of the Program
    Description
    Descriptive summary of participants' reports from closing interview of what they like and do not like about the program, any challenges they experienced with doing the program, and whether they plan to continue what they learned.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of Falls
    Description
    Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.
    Time Frame
    Baseline to Month 6
    Title
    Number of People With Severe of Falls
    Description
    Participant will record whether the fall resulted in an injury and the type of injury that occurred. A fall will be considered severe if an injury occurred.
    Time Frame
    Baseline to Month 6
    Title
    Berg Balance Scale
    Description
    This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
    Time Frame
    Baseline
    Title
    Four-tests Balance: Feet Together Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Baseline
    Title
    Hand Grip Dynamometry Right Hand
    Description
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Time Frame
    Baseline
    Title
    30-second Chair Stand Test
    Description
    Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
    Time Frame
    Baseline
    Title
    Timed Up and Go Test
    Description
    Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
    Time Frame
    Baseline
    Title
    Stair Climb Test
    Description
    Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
    Time Frame
    Baseline
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index
    Description
    This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
    Time Frame
    Baseline
    Title
    Activities-specific Balance Confidence Scale
    Description
    Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
    Time Frame
    Baseline
    Title
    Rapid Assessment of Physical Activity: Aerobic Score
    Description
    Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: I rarely or never do any physical activities. Under-active: I do some light or moderate physical activities, but not every week. Under-active regular - light activities: I do some light physical activity every week. Under-active regular: I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
    Time Frame
    Baseline
    Title
    Berg Balance Scale
    Description
    This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
    Time Frame
    Week 8
    Title
    Berg Balance Scale
    Description
    This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).
    Time Frame
    Month 6
    Title
    Four-tests Balance: Feet Together Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Week 8
    Title
    Four-tests Balance: Feet Together Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Month 6
    Title
    Four-tests Balance: Semi-tandem Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Baseline
    Title
    Four-tests Balance: Semi-tandem Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Week 8
    Title
    Four-tests Balance: Semi-tandem Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Month 6
    Title
    Four-tests Balance: Tandem Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Baseline
    Title
    Four-tests Balance: Tandem Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Week 8
    Title
    Four-tests Balance: Tandem Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Month 6
    Title
    Four-tests Balance: One Leg Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Baseline
    Title
    Four-tests Balance: One Leg Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Week 8
    Title
    Four-tests Balance: One Leg Stand
    Description
    Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.
    Time Frame
    Month 6
    Title
    Hand Grip Dynamometry Right Hand
    Description
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Time Frame
    Week 8
    Title
    Hand Grip Dynamometry Right Hand
    Description
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Time Frame
    Month 6
    Title
    Hand Grip Dynamometry Left Hand
    Description
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Time Frame
    Baseline
    Title
    Hand Grip Dynamometry Left Hand
    Description
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Time Frame
    Week 8
    Title
    Hand Grip Dynamometry Left Hand
    Description
    Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.
    Time Frame
    Month 6
    Title
    30-second Chair Stand Test
    Description
    Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
    Time Frame
    Week 8
    Title
    30-second Chair Stand Test
    Description
    Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.
    Time Frame
    Month 6
    Title
    Timed Up and Go Test
    Description
    Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
    Time Frame
    Week 8
    Title
    Timed Up and Go Test
    Description
    Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.
    Time Frame
    Month 6
    Title
    Stair Climb Test
    Description
    Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
    Time Frame
    Week 8
    Title
    Stair Climb Test
    Description
    Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.
    Time Frame
    Month 6
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index
    Description
    This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
    Time Frame
    Week 8
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index
    Description
    This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).
    Time Frame
    Month 6
    Title
    Activities-specific Balance Confidence Scale
    Description
    Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
    Time Frame
    Week 8
    Title
    Activities-specific Balance Confidence Scale
    Description
    Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.
    Time Frame
    Month 6
    Title
    Rapid Assessment of Physical Activity: Aerobic Score
    Description
    Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: I rarely or never do any physical activities. Under-active: I do some light or moderate physical activities, but not every week. Under-active regular - light activities: I do some light physical activity every week. Under-active regular: I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
    Time Frame
    Week 8
    Title
    Rapid Assessment of Physical Activity: Aerobic Score
    Description
    Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels. Sedentary: I rarely or never do any physical activities. Under-active: I do some light or moderate physical activities, but not every week. Under-active regular - light activities: I do some light physical activity every week. Under-active regular: I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week. I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week. Active: I do 30 minutes or more a day of moderate physical activities, 5 or more days a week. I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week.
    Time Frame
    Month 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: history of falls knee or hip radiographic OA 65+ years of age normal cognitive function (based on the Mini-Mental State Examination) current knee/hip symptoms Exclusion Criteria: hospitalized for stroke, myocardial infarction, or coronary artery revascularization in past 3 months diagnosis of metastatic cancer in the past 3 months terminal illness progressive neurological disorders rheumatoid arthritis severe fibromyalgia other systemic rheumatic disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yvonne Golightly, PT, PhD
    Organizational Affiliation
    University of North Carolina, Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Falls Prevention Program for Adults With Osteoarthritis

    We'll reach out to this number within 24 hrs