Frail ElderlyNCT03095534
Translating 3-Step Workout for Life in a Local Senior Living Community
A study testing 3-Step Workout for Life in people with Frail Elderly and Muscle Weakness, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Frail Elderly, Muscle Weakness
- What is being tested?
- 3-Step Workout for Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 11 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University (IUPUI Campus)
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Frail Elderly, Muscle Weakness
- Being tested
- 3-Step Workout for Life
- Keywords
- Occupational Therapy, Aging in place, Activities of daily living, Community program
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Step Workout for LifeBehavioural
a 10-week moderate exercise program
| Study group | Role | What they receive |
|---|---|---|
| 3-Step Workout for Life | Experimental | 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. Receives: Behavioral: 3-Step Workout for Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Motor and Process Skills (AMPS)-the motor skill scale
To measure motor ability required to competently complete daily activities
Measured: 12 weeks
Secondary outcomes (5)
Box and Block Test
To measure motor coordination of the upper extremity
Measured: 12 weeks
Timed Up and Go
To measure functional mobility
Measured: 12 weeks
30-second arm curl test
To measure muscle strength of the upper extremity
Measured: 12 weeks
30-second chair stand test
To measure muscle strength of the lower extremity
Measured: 12 weeks
Canadian Occupational Performance Measure
To measure self-perception of performance in everyday living
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2017
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group with pretest and posttest
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu, Chiung-ju (CJ), Indiana University
- Investigators
- Chiung-ju Liu, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095534
- Sponsor's protocol ID
- 1609528804
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26583695
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating 3-Step Workout for Life in a Local Senior Living Community: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03095534
- Acronym / sponsor ID
- 1609528804
- Conditions
- Frail Elderly, Muscle Weakness
- Keywords
- Occupational Therapy, Aging in place, Activities of daily living, Community program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group with pretest and posttest
| Arm | Type | Receives |
|---|---|---|
| 3-Step Workout for Life | Experimental | Behavioral: 3-Step Workout for LifeParticipants 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Step Workout for Lifea 10-week moderate exercise program | Behavioural | 3-Step Workout for Life |
Primary outcome
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
5 secondary outcomes
Box and Block Test
Time frame: 12 weeks
Timed Up and Go
Time frame: 12 weeks
30-second arm curl test
Time frame: 12 weeks
30-second chair stand test
Time frame: 12 weeks
Canadian Occupational Performance Measure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 26583695Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiung-ju Liu principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Step Workout for Life in people with Frail Elderly and Muscle Weakness, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Motor and Process Skills (AMPS)-the motor skill scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.