- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095534
Translating 3-Step Workout for Life in a Local Senior Living Community
April 12, 2018 updated by: Liu, Chiung-ju (CJ), Indiana University
Translating 3-Step Workout for Life in a Local Senior Living Community: A Feasibility Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University (IUPUI Campus)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 3-Step Workout for Life
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.
|
a 10-week moderate exercise program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Motor and Process Skills (AMPS)-the motor skill scale
Time Frame: 12 weeks
|
To measure motor ability required to competently complete daily activities
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test
Time Frame: 12 weeks
|
To measure motor coordination of the upper extremity
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12 weeks
|
|
Timed Up and Go
Time Frame: 12 weeks
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To measure functional mobility
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12 weeks
|
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30-second arm curl test
Time Frame: 12 weeks
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To measure muscle strength of the upper extremity
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12 weeks
|
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30-second chair stand test
Time Frame: 12 weeks
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To measure muscle strength of the lower extremity
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12 weeks
|
|
Canadian Occupational Performance Measure
Time Frame: 12 weeks
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To measure self-perception of performance in everyday living
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12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment
Time Frame: 12 weeks
|
Global cognitive function measure
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12 weeks
|
|
Patient Health Questionnaire (PHQ-9 )
Time Frame: 12 weeks
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To measure the degree of depression
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12 weeks
|
|
A Three-Item Scale Assessing Pain Intensity and Interference (PEG)
Time Frame: 12 weeks
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To measure the degree of pain and interfering with enjoyment of life and genera activities
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12 weeks
|
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UCLA Loneliness Scale
Time Frame: 12 weeks
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To measure the degree of loneliness
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12 weeks
|
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Pearlin Mastery Scale
Time Frame: 12 weeks
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To measure personal mastery
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chiung-ju Liu, Indiana University School of Health & Rehabilitation Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2017
Primary Completion (ACTUAL)
December 31, 2017
Study Completion (ACTUAL)
April 11, 2018
Study Registration Dates
First Submitted
March 20, 2017
First Submitted That Met QC Criteria
March 23, 2017
First Posted (ACTUAL)
March 29, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 17, 2018
Last Update Submitted That Met QC Criteria
April 12, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1609528804
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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