ClinicalTrials.gg
CompletedNCT03301116Updated Jun 27, 2025

Promoting Seniors' Health With Home Care Aides

An interventional study of Healthy Moves for Aging Well (Healthy Moves) and Active Mind for Aging Well (Active Mind) in Muscle Weakness, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 60 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
157
Allocation
Randomized
Ages
60 Years to 110 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 145 studies in Muscle Weakness with a site in United States — 21 open to participants now, 27 under way, none of them phase 3. Muscle Weakness · United States.

Enrollment
13th of 113
157 · median 32
Started
2017
with 11 others
No phase
81 of 145
9 open now
Registered
58th of 145
by date

Among the 145 studies in Muscle Weakness with a site in United States, this one is the 13th largest by enrollment of the 113 interventional ones that give a count, is one of 12 that started in 2017, is one of 81 with no phase, and was the 58th registered.

Muscle Weakness

477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.

Browse Muscle Weakness studies →

Open to participants now

21 of the 145 studies in Muscle Weakness with a site in United States are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 54 Muscle Weakness studies recruiting now, 24 (44%) set no upper age limit and 22 (41%) stop at 75 or younger; 6 take children under 18; 19 take healthy volunteers.

This study: 60 Years to 110 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Muscle Weakness

Keywords

  • Exercise
  • Frail Elderly
  • Homebound Persons
  • Activities of Daily Living
  • Mobility Limitation
  • Home Care Services
  • Long-Term Care
  • Dual MEDICAID MEDICARE Eligibility
04

Who can participate

Ages eligible
60 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

HOME CARE CLIENTS

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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

Exclusion Criteria

  • Not having a home care client who participates in the study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
157 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Healthy Moves for Aging Well (Healthy Moves)

  • Active comparator
    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.

    Behavioral: Active Mind for Aging Well (Active Mind)

Interventions

  • BehavioralHealthy 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.

  • BehavioralActive 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Month 4

Secondary outcomes

  1. Short Physical Performance Battery (SPPB)

    Range 0-12 (Guralnik et al., 1994)

    Time frame: Baseline, Month 4, Month 8

  2. 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)

    Time frame: Baseline, Month 4, Month 8

  3. Self-rated health

    General self-rated health, range 1-5 (poor to excellent)

    Time frame: Baseline, Month 4, Month 8

  4. 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).

    Time frame: Baseline, Month 4, Month 8

Other outcomes

  1. Basic activities of daily living (secondary outcome)

    8-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-16 (Gill, Robinson, and Tinetti, 1998)

    Time frame: Baseline, Month 4, Month 8

  2. Activities of daily living that are specifically targeted by the intervention (secondary outcome)

    6-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-12

    Time frame: Baseline, Month 4, Month 8

  3. Instrumental activities of daily living (secondary outcome)

    4-item scale; each task will be scored 0-no difficulty/no help; 1=difficulty but no help; 2=need help, summed score range 0-8

    Time frame: Baseline, Month 4, Month 8

  4. Physical activity levels (secondary outcome)

    Days and amount of time spent on three types of physical activity in the past week: strengthening, stretching, and aerobics

    Time frame: Baseline, Month 4, Month 8

  5. Falls (secondary outcome)

    Number of falls in the past 4 months, and whether any reported falls led to injury that needed medical attention (Yes/No)

    Time frame: Baseline, Month 4, Month 8

  6. Ankle range of motion (secondary outcome)

    Angle between ankle dorsiflexion and plantarflexion in degrees

    Time frame: Baseline, Month 4, Month 8

  7. Pain (secondary outcome)

    A scale adapted from SF36 to measure pain, after taking pain medication if applicable, range 0-10

    Time frame: Baseline, Month 4, Month 8

  8. Depressive symptoms (secondary outcome)

    Feelings in the past week. 9-item scale (Yes/No), range 0-9

    Time frame: Baseline, Month 4, Month 8

07

Study locations

1 site
  • University of Illinois at Chicago
    Chicago, Illinois 60608, United States
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: After the publication of the main study results

Access criteria: To protect participants from re-identification while retaining the analytic utility of the data, the data and associated documentation will be available to users only under a data-sharing agreement, managed by the National Archive of Computerized Data on Aging (NACDA), that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will only be released once all Institutional Review Board (IRB) approvals and human subjects concerns have been addressed.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Dec 2022, 63 months.

Of 200 non-industry interventional studies with no phase under Muscle Weakness, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 63 months is above that.

Counting every sponsor, half of 212 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2017
First posted
Oct 4, 2017
StartActual
Sep 1, 2017
Primary completionActual
Dec 7, 2022
CompletionActual
Dec 7, 2022
Last update
Jun 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03301116
Responsible party
Naoko Muramatsu (Associate Professor, University of Illinois at Chicago) — Principal investigator
First posted
Oct 4, 2017
Start date
Sep 1, 2017
Primary completion
Dec 7, 2022
Completion
Dec 7, 2022
Last update
Jun 27, 2025

Study contacts

Naoko Muramatsu, PhD
principal investigator · University of Illinois at Chicago

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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