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
About this trial
This is an interventional prevention trial for Osteoarthritis
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
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
NCT ID
NCT02648646
First Posted
November 2, 2015
Last Updated
February 6, 2018
Sponsor
University of North Carolina, Chapel Hill
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