Back to resultsTranslating 3-Step Workout for Life in a Local Senior Living Community
Primary Purpose
Frail Elderly, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-Step Workout for Life
Sponsored by
About this trial
This is an interventional prevention trial for Frail Elderly focused on measuring Occupational Therapy, Aging in place, Activities of daily living, Community program
Eligibility Criteria
Inclusion Criteria:
- Aged 60 years old and above
- Residents of the local study community
- Communicable in English
- Took more than 16 seconds to complete five chair stands with arms crossed at the chest.
- Self-reported difficulty in performing one or more activities of daily living, which must include difficulty in feeding/eating, dressing, grooming/personal hygiene, bathing/showering, using the toilet, or functional mobility/transfer.
Exclusion Criteria:
- Aged above 90 years old.
- Unwilling to commit to the study program 3 sessions per week for 10 weeks.
- Plan to move away from the current community in 6 months.
- Having three or more errors on a six-item cognitive impairment screener.
- Having any terminal illness, cardiovascular, neurological, psychiatric, orthopedic, or cognitive impairments that are contraindications to participating in an exercise program.
- The difficulty of performing activities of daily living is due to neurological disorders (e.g., stroke, Parkinson's), orthopedic conditions (e.g, amputees), or sensory deficits (diabetic palsy, low vision).
- Physician's recommendation of no moderate physical exercise.
- Receiving home health rehabilitation therapy or exercise at moderate intensity for more than twice a week (last more than 20 minutes each time).
Sites / Locations
- Indiana University (IUPUI Campus)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3-Step Workout for Life
Arm Description
Participants will exercise at the moderate intensity three times a week for 10 weeks. The total of 30 workout sessions will consist of 18 sessions of group single-joint resistance exercise, 6 sessions of one-on-one multiple-joint resistance exercise, and 6 sessions of one-on-one activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice daily tasks around the home. The community fitness staff will modify the task demand to increase the physical challenge of the task to each participant, for example, increasing travel distance.
Outcomes
Primary Outcome Measures
Assessment of Motor and Process Skills (AMPS)-the motor skill scale
To measure motor ability required to competently complete daily activities
Secondary Outcome Measures
Box and Block Test
To measure motor coordination of the upper extremity
Timed Up and Go
To measure functional mobility
30-second arm curl test
To measure muscle strength of the upper extremity
30-second chair stand test
To measure muscle strength of the lower extremity
Canadian Occupational Performance Measure
To measure self-perception of performance in everyday living
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03095534
Brief Title
Translating 3-Step Workout for Life in a Local Senior Living Community
Official Title
Translating 3-Step Workout for Life in a Local Senior Living Community: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
April 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates the feasibility of a staff-lead workout program, 3-Step Workout for Life, in a local senior living community. Eligible participants will complete assessments before and after the workout program.
Detailed Description
The 3-Step Workout for Life program is designed to help older adults improve muscle strength and apply the improved muscle strength to perform activities of daily living. The 10-week workout consists of single-joint resistance exercise, multiple-joint resistance exercise, and activities of daily living exercise. Participants will exercise in small groups in a community room as well as one-on-one with the fitness staff in their home. The community fitness staff will learn the 3-Step Workout for Life program from the University partner and deliver the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly, Muscle Weakness
Keywords
Occupational Therapy, Aging in place, Activities of daily living, Community program
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group with pretest and posttest
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-Step Workout for Life
Arm Type
Experimental
Arm Description
Participants will exercise at the moderate intensity three times a week for 10 weeks. The total of 30 workout sessions will consist of 18 sessions of group single-joint resistance exercise, 6 sessions of one-on-one multiple-joint resistance exercise, and 6 sessions of one-on-one activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice daily tasks around the home. The community fitness staff will modify the task demand to increase the physical challenge of the task to each participant, for example, increasing travel distance.
Intervention Type
Behavioral
Intervention Name(s)
3-Step Workout for Life
Intervention Description
a 10-week moderate exercise program
Primary Outcome Measure Information:
Title
Assessment of Motor and Process Skills (AMPS)-the motor skill scale
Description
To measure motor ability required to competently complete daily activities
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Box and Block Test
Description
To measure motor coordination of the upper extremity
Time Frame
12 weeks
Title
Timed Up and Go
Description
To measure functional mobility
Time Frame
12 weeks
Title
30-second arm curl test
Description
To measure muscle strength of the upper extremity
Time Frame
12 weeks
Title
30-second chair stand test
Description
To measure muscle strength of the lower extremity
Time Frame
12 weeks
Title
Canadian Occupational Performance Measure
Description
To measure self-perception of performance in everyday living
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Montreal Cognitive Assessment
Description
Global cognitive function measure
Time Frame
12 weeks
Title
Patient Health Questionnaire (PHQ-9 )
Description
To measure the degree of depression
Time Frame
12 weeks
Title
A Three-Item Scale Assessing Pain Intensity and Interference (PEG)
Description
To measure the degree of pain and interfering with enjoyment of life and genera activities
Time Frame
12 weeks
Title
UCLA Loneliness Scale
Description
To measure the degree of loneliness
Time Frame
12 weeks
Title
Pearlin Mastery Scale
Description
To measure personal mastery
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 60 years old and above
Residents of the local study community
Communicable in English
Took more than 16 seconds to complete five chair stands with arms crossed at the chest.
Self-reported difficulty in performing one or more activities of daily living, which must include difficulty in feeding/eating, dressing, grooming/personal hygiene, bathing/showering, using the toilet, or functional mobility/transfer.
Exclusion Criteria:
Aged above 90 years old.
Unwilling to commit to the study program 3 sessions per week for 10 weeks.
Plan to move away from the current community in 6 months.
Having three or more errors on a six-item cognitive impairment screener.
Having any terminal illness, cardiovascular, neurological, psychiatric, orthopedic, or cognitive impairments that are contraindications to participating in an exercise program.
The difficulty of performing activities of daily living is due to neurological disorders (e.g., stroke, Parkinson's), orthopedic conditions (e.g, amputees), or sensory deficits (diabetic palsy, low vision).
Physician's recommendation of no moderate physical exercise.
Receiving home health rehabilitation therapy or exercise at moderate intensity for more than twice a week (last more than 20 minutes each time).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiung-ju Liu
Organizational Affiliation
Indiana University School of Health & Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University (IUPUI Campus)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26583695
Citation
Liu CJ, Jones LY, Formyduval A RM, Clark DO. Task-Oriented Exercise to Reduce Activities of Daily Living Disability in Vulnerable Older Adults: A Feasibility Study of the 3-Step Workout for Life. J Aging Phys Act. 2016 Jul;24(3):384-92. doi: 10.1123/japa.2015-0070. Epub 2015 Nov 19.
Results Reference
background
Learn more about this trial
Translating 3-Step Workout for Life in a Local Senior Living Community
We'll reach out to this number within 24 hrs