Muscle WeaknessNCT03301116
Promoting Seniors' Health With Home Care Aides
A study testing Healthy Moves for Aging Well (Healthy Moves) and Active Mind for Aging Well (Active Mind) in people with Muscle Weakness, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Healthy Moves for Aging Well (Healthy Moves) and Active Mind for Aging Well (Active Mind)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 7 Dec 2022
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish-speaking older adults aged 60+
- Receiving Illinois Department on Aging Community Care Program In-Home service from the collaborating home care agency
- Able to sit in a chair independently for >=15 minutes (it is fine if the person needs help with transferring to a chair)
- Cognitive status sufficient to follow directions and respond to survey questions as determined by the Six-Item Screener (Callahan, et al., 2002) (the instrument used in the phone screening) and the Modified Mini-Mental State (3MS) Examination (the instrument used in the in-home screening)
- Willing to be assigned to either intervention program
- Willing to have the research team notify the primary care physician of the client's study participation
Show all 11Show fewer
- English or Spanish-speaking home care aide caring for an older home care client eligible for the study
- Age 18 and older
- Willing to implement the intervention program routine with their eligible client(s) for the full 4 months
- Willing to be randomly assigned to either intervention program
- Intend to be a home care aide for the next 12 months
Who cannot join
- Having a legal guardian appointed
- Bedridden or unable to sit in a chair independently
- Receiving hospice care or having a terminal diagnosis
- Self-reported inability to read large print books
- HOME CARE AIDES
- Not having a home care client who participates in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
Official title: Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.
Read the detailed description
Regular physical activity benefits older adults physically and mentally. However, the availability and the evidence for physical activity programs that are safe and appropriate for home-bound older adults at risk for nursing home admission are limited. The current project aims to examine the effectiveness of a safe physical activity program, led by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home. The primary aim is to test whether the safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of home care clients. The secondary aim is to understand for whom the program is efficacious, the extent to which the program can reach the target population, the extent to which participants drop out of the program, the extent to which program participants maintain the behavioral change introduced by the intervention, and what the program's cost-effectiveness is. Building on a pilot project that demonstrated the program's feasibility in a large home care program funded by the state and Medicaid, this randomized controlled trial will inform future expansion of the physical activity program into real-world home care settings.
- Conditions
- Muscle Weakness
- Being tested
- Healthy Moves for Aging Well (Healthy Moves), Active Mind for Aging Well (Active Mind)
- Keywords
- Exercise, Frail Elderly, Homebound Persons, Activities of Daily Living, Mobility Limitation, Home Care Services, Long-Term Care, Dual MEDICAID MEDICARE Eligibility
- Medical subject headings
- Muscle Weakness, Motor Activity, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Moves for Aging Well (Healthy Moves)Behavioural
A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position. The intervention will be delivered by home care aides for their clients.
Active Mind for Aging Well (Active Mind)Behavioural
A word puzzle program which consists of a brief motivational enhancement and word search activities. The intervention will be delivered by home care aides for their clients.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Moves | Experimental | Home care aides (HCAs) will be trained to deliver Healthy Moves for Aging Well (Healthy Moves), a gentle physical activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the three chair-bound moves. Home care clients will be asked to do the three moves every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period. Receives: Behavioral: Healthy Moves for Aging Well (Healthy Moves) |
| Active Mind | Active comparator | Home care aides (HCAs) will be trained to deliver Active Mind for Aging Well (Active Mind), a gentle thinking activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the activity. Home care clients will be asked to do a word search puzzle every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period. Receives: Behavioral: Active Mind for Aging Well (Active Mind) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4
Activities of daily living that are specifically targeted by the intervention (6-items scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help; summed score, range 0-12)
Measured: Month 4
Secondary outcomes (4)
Short Physical Performance Battery (SPPB)
Range 0-12 (Guralnik et al., 1994)
Measured: Baseline, Month 4, Month 8
Exercise-related social support from home care aides
Frequency of support from home care aides. Three items, range 3-9. Adapted from Sallis et al. (1987)
Measured: Baseline, Month 4, Month 8
Self-rated health
General self-rated health, range 1-5 (poor to excellent)
Measured: Baseline, Month 4, Month 8
Fear of falling
Short Falls Efficacy Scale-International (FES-I), seven items, 4-point scale (not at all worried to very worried), range 7-28 (Kempen et al., 2008).
Measured: Baseline, Month 4, Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Sep 2017
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Home care aide-client pairs will be randomly assigned to one of two groups in parallel for the duration of the study. Home care aides will not be allowed to have multiple participating clients assigned to different groups to prevent group contamination.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Naoko Muramatsu, University of Illinois Chicago
- Investigators
- Naoko Muramatsu, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301116
- Sponsor's protocol ID
- 2016-0689
- Other IDs
- R01AG053675
- Status last verified
- Jun 2025
- First submitted
- 21 Sep 2017
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the end of the study, data collection instruments, codebooks, and other data documentation will be made available in conjunction with the dataset in a standard format that is readable across a variety of applications. Guidelines from relevant state agencies and collaborators will be followed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Seniors' Health With Home Care Aides: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03301116
- Acronym / sponsor ID
- 2016-0689
- Conditions
- Muscle Weakness
- Keywords
- Exercise, Frail Elderly, Homebound Persons, Activities of Daily Living, Mobility Limitation, Home Care Services, Long-Term Care, Dual MEDICAID MEDICARE Eligibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 4 Oct 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.
This study aims to test whether a safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of older home care clients.
Detailed description
Regular physical activity benefits older adults physically and mentally. However, the availability and the evidence for physical activity programs that are safe and appropriate for home-bound older adults at risk for nursing home admission are limited. The current project aims to examine the effectiveness of a safe physical activity program, led by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home. The primary aim is to test whether the safe physical activity program with a built-in motivational enhancement component, performed in a seated position, preserves the function and well-being of home care clients. The secondary aim is to understand for whom the program is efficacious, the extent to which the program can reach the target population, the extent to which participants drop out of the program, the extent to which program participants maintain the behavioral change introduced by the intervention, and what the program's cost-effectiveness is. Building on a pilot project that demonstrated the program's feasibility in a large home care program funded by the state and Medicaid, this randomized controlled trial will inform future expansion of the physical activity program into real-world home care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Home care aide-client pairs will be randomly assigned to one of two groups in parallel for the duration of the study. Home care aides will not be allowed to have multiple participating clients assigned to different groups to prevent group contamination.
| Arm | Type | Receives |
|---|---|---|
| Healthy Moves | Experimental | Behavioral: Healthy Moves for Aging Well (Healthy Moves)Home care aides (HCAs) will be trained to deliver Healthy Moves for Aging Well (Healthy Moves), a gentle physical activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the three chair-bound moves. Home care clients will be asked to do the three moves every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period. |
| Active Mind | Active comparator | Behavioral: Active Mind for Aging Well (Active Mind)Home care aides (HCAs) will be trained to deliver Active Mind for Aging Well (Active Mind), a gentle thinking activity program, to their clients. On the first home care visit after the training, HCAs will introduce the program, assess their clients' readiness for the activity and have their clients set personally meaningful goals, and teach the activity. Home care clients will be asked to do a word search puzzle every day. HCAs remind clients of their activity as part of their regular home care visits throughout the 4-month intervention period. |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- English or Spanish-speaking older adults aged 60+
- Receiving Illinois Department on Aging Community Care Program In-Home service from the collaborating home care agency
- Able to sit in a chair independently for >=15 minutes (it is fine if the person needs help with transferring to a chair)
- Cognitive status sufficient to follow directions and respond to survey questions as determined by the Six-Item Screener (Callahan, et al., 2002) (the instrument used in the phone screening) and the Modified Mini-Mental State (3MS) Examination (the instrument used in the in-home screening)
- Willing to be assigned to either intervention program
Key exclusion criteria (6 listed)
- Having a legal guardian appointed
- Bedridden or unable to sit in a chair independently
- Receiving hospice care or having a terminal diagnosis
- Self-reported inability to read large print books
- HOME CARE AIDES
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 |
|---|---|---|
| Healthy Moves for Aging Well (Healthy Moves)A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position. The intervention will be delivered by home care aides for their clients. | Behavioural | Healthy Moves |
| Active Mind for Aging Well (Active Mind)A word puzzle program which consists of a brief motivational enhancement and word search activities. The intervention will be delivered by home care aides for their clients. | Behavioural | Active Mind |
Primary outcome
Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4
Time frame: Month 4
Activities of daily living that are specifically targeted by the intervention (6-items scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help; summed score, range 0-12)
4 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline, Month 4, Month 8
Exercise-related social support from home care aides
Time frame: Baseline, Month 4, Month 8
Self-rated health
Time frame: Baseline, Month 4, Month 8
Fear of falling
Time frame: Baseline, Month 4, Month 8
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 27 Jun 2025.
- Individual participant dataSharing planned: Yes. After the end of the study, data collection instruments, codebooks, and other data documentation will be made available in conjunction with the dataset in a standard format that is readable across a variety of applications. Guidelines from relevant state agencies and collaborators will be followed.
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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.
Naoko Muramatsu, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Moves for Aging Well (Healthy Moves) and Active Mind for Aging Well (Active Mind) in people with Muscle Weakness, run by University of Illinois Chicago 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 11 inclusion and 6 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 27 Jun 2025. 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?
Change from Baseline Function (Daily activity difficulties and dependency in older home care clients) at Month 4 (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.