AgingHEXNCT04034888
Home Exercise Program for Homebound Older Adults
A study testing HEX in people with Aging, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Exercise can be beneficial for older adults by promoting health, delaying or reversing functional decline, reducing chronic disease risk, decreasing falls, increasing strength and stamina, improving ability to perform activities of daily living (ADL), and improving overall quality of life (QOL). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- HEX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 30 May 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Veteran enrolled in the Veterans Administration Medical Health Care System's Home- Based Primary Care Program
- Aged 65 years or older
Who cannot join
- Paraplegia
- Life expectancy of less than 12 months
- Currently engaged in a physical therapy program
- Any medical condition(s) or contraindications precluding patient participation in the study as per medical judgement of study team
Trial locations and contacts
1 site in 1 country.
About this study
Exercise can be beneficial for older adults by promoting health, delaying or reversing functional decline, reducing chronic disease risk, decreasing falls, increasing strength and stamina, improving ability to perform activities of daily living (ADL), and improving overall quality of life (QOL). Developing and implementing exercise programs for homebound older adults for whom traveling to routine clinic-based appointments may not be feasible or safe becomes critical. Homebound, older adults are at increased risk for recurrent hospitalization, use of emergency care, nursing home placement, and death. Indeed, one study shows patients had significantly higher risk of being admitted into a hospital or nursing home, higher mortality, and higher health care expenditures compared to those in a comparison group. The purpose of this pilot is to develop and implement a pragmatic and feasible intervention to improve physical functioning in older homebound adults with chronic mobility disability. Unfortunately, little is known about the feasibility and utility of pragmatic home-based exercise rehabilitation in older adults with severe mobility limitations.
The investigators propose to develop and implement an intervention targeting functional limitations in this population with mobility disability. Our overall goals are to maintain and restore physical functioning and QOL for older, homebound adults. This research carries direct benefits for these patients as even modest improvements in disabled older adults may translate into significantly better QOL, reduce disability, minimize or reverse gradual declines related to serious chronic disease, resort functional independence, and increase community living capacity. Thus, the specified objectives of finalizing and implementing a sustainable home-based exercise program have practical implications for disabled older adults. Were homebound patients even slightly higher in terms of functional capacity, it could provide a partial degree of functional independence, impacting QOL for both patients and caregivers.
Read the detailed description
The purpose of this study is to develop and implement a pragmatic and feasible intervention to improve physical functioning in older homebound adults with chronic mobility disability. Unfortunately, little is known about the feasibility and utility of pragmatic home-based exercise rehabilitation in older adults with severe mobility limitations.
The Specific Aims and Hypotheses of this proposal are:
Specific Aim #1: Using human-centered design methodologies, work with providers and patients to develop a feasible multi-component home exercise program targeting mobility, strength, and performance of task-oriented ADLs. Feasibility will be determined by assessing adherence and retention to the developed exercise program.
Hypothesis 1: The investigators hypothesize that a task-based exercise intervention can be feasibly delivered in the homes of homebound, older adults.
Specific Aim #2: Perform a feasibility study to better assess feasibility and determine the effect(s) of the home-based intervention created in Aim 1 on functional outcomes (primary outcome SPPB), mobility, and QOL changes in homebound older adults with mobility disability.
Hypothesis 2: The investigators hypothesize that the developed 12-week multi-component exercise intervention will improve performance of basic ADLs, functional mobility, and QOL; as well as outcomes related to patient satisfaction, emergency department visits, and hospitalization.
- Conditions
- Aging
- Being tested
- HEX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEXBehavioural
HEX is a customized exercise program with components including: 1) controlled flexibility movements; 2) progressive ADL training focusing on bed mobility, bed to chair transfers, and indoor walking; 3) task-specific seated resistance training to improve ability to get out of bed and; 4) and balance exercises. Participants will be expected to perform their HEX program at least 2 times/week in their home and all individualized exercise sessions will be supervised by an Exercise Physiologist. Each exercise has four levels of difficulty, which will be progressed as tolerated throughout the 12-weeks. Seated resistance exercises were designed to target all the major muscle groups and will include the following: arm curls, shoulder raises (lateral/front), overhead arm raise, wrist curls, leg extensions, hip flexion, hip ab/adduction, sit-to-stands, torso rotation, and marching.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Program (HEX) | Experimental | Customized home exercise program Receives: Behavioral: HEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery
captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (4)
Change in 30-second sit-to-stand test
determines lower extremity strength and endurance in older adults. The number of sit-to-stands is recorded.
Measured: Baseline, 6 weeks, 12-weeks
Change in 30-second arm curl test
determines upper extremity strength and endurance in older adults. The number of arm curls is recorded.
Measured: Baseline, 6 weeks, 12-weeks
Change in Grip Strength
This is a surrogate marker for sarcopenia and will be measured with a hand dynamometer. The arm to be tested held by the participant's side and elbow at a 90° angle. The participant squeezes the hand as hard as possible for few seconds. The best out of two trials separated by 60 seconds will be used.
Measured: Baseline, 6 weeks, 12 weeks
Change in Lower Extremity Strength
will be measured with a wireless digital handheld manual muscle dynamometer during leg extension. To evaluate the knee extensor muscles, the dynamometer will be placed on the anterior part of the lower leg. Participants will perform 3 isometric maximal voluntary contractions of 5 seconds with a 60-second recovery period between contractions.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Feb 2020
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyssa Stookey, University of Maryland, Baltimore
- Investigators
- Alyssa Stookey, PhD, Principal investigator, University of Maryland School of Medicine and Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034888
- Sponsor's protocol ID
- UMaryland
- Acronym
- HEX
- Status last verified
- Dec 2024
- First submitted
- 16 Jul 2019
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers outside of our study team.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Exercise Program for Homebound Older Adults
- ClinicalTrials.gov ID
- NCT04034888
- Acronym / sponsor ID
- HEX / UMaryland
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 26 Jul 2019 (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.
Exercise can be beneficial for older adults by promoting health, delaying or reversing functional decline, reducing chronic disease risk, decreasing falls, increasing strength and stamina, improving ability to perform activities of daily living (ADL), and improving overall quality of life (QOL). Developing and implementing exercise programs for homebound older adults for whom traveling to routine clinic-based appointments may not be feasible or safe becomes critical. Homebound, older adults are at increased risk for recurrent hospitalization, use of emergency care, nursing home placement, and death. Indeed, one study shows patients had significantly higher risk of being admitted into a hospital or nursing home, higher mortality, and higher health care expenditures compared to those in a comparison group. The purpose of this pilot is to develop and implement a pragmatic and feasible intervention to improve physical functioning in older homebound adults with chronic mobility disability. Unfortunately, little is known about the feasibility and utility of pragmatic home-based exercise rehabilitation in older adults with severe mobility limitations.
The investigators propose to develop and implement an intervention targeting functional limitations in this population with mobility disability. Our overall goals are to maintain and restore physical functioning and QOL for older, homebound adults. This research carries direct benefits for these patients as even modest improvements in disabled older adults may translate into significantly better QOL, reduce disability, minimize or reverse gradual declines related to serious chronic disease, resort functional independence, and increase community living capacity. Thus, the specified objectives of finalizing and implementing a sustainable home-based exercise program have practical implications for disabled older adults. Were homebound patients even slightly higher in terms of functional capacity, it could provide a partial degree of functional independence, impacting QOL for both patients and caregivers.
Detailed description
The purpose of this study is to develop and implement a pragmatic and feasible intervention to improve physical functioning in older homebound adults with chronic mobility disability. Unfortunately, little is known about the feasibility and utility of pragmatic home-based exercise rehabilitation in older adults with severe mobility limitations.
The Specific Aims and Hypotheses of this proposal are:
Specific Aim #1: Using human-centered design methodologies, work with providers and patients to develop a feasible multi-component home exercise program targeting mobility, strength, and performance of task-oriented ADLs. Feasibility will be determined by assessing adherence and retention to the developed exercise program.
Hypothesis 1: The investigators hypothesize that a task-based exercise intervention can be feasibly delivered in the homes of homebound, older adults.
Specific Aim #2: Perform a feasibility study to better assess feasibility and determine the effect(s) of the home-based intervention created in Aim 1 on functional outcomes (primary outcome SPPB), mobility, and QOL changes in homebound older adults with mobility disability.
Hypothesis 2: The investigators hypothesize that the developed 12-week multi-component exercise intervention will improve performance of basic ADLs, functional mobility, and QOL; as well as outcomes related to patient satisfaction, emergency department visits, and hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Program (HEX) | Experimental | Behavioral: HEXCustomized home exercise program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Veteran enrolled in the Veterans Administration Medical Health Care System's Home- Based Primary Care Program
- Aged 65 years or older
Key exclusion criteria (4 listed)
- Paraplegia
- Life expectancy of less than 12 months
- Currently engaged in a physical therapy program
- Any medical condition(s) or contraindications precluding patient participation in the study as per medical judgement of study team
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 |
|---|---|---|
| HEXHEX is a customized exercise program with components including: 1) controlled flexibility movements; 2) progressive ADL training focusing on bed mobility, bed to chair transfers, and indoor walking; 3) task-specific seated resistance training to improve ability to get out of bed and; 4) and balance exercises. Participants will be expected to perform their HEX program at least 2 times/week in their home and all individualized exercise sessions will be supervised by an Exercise Physiologist. Each exercise has four levels of difficulty, which will be progressed as tolerated throughout the 12-weeks. Seated resistance exercises were designed to target all the major muscle groups and will include the following: arm curls, shoulder raises (lateral/front), overhead arm raise, wrist curls, leg extensions, hip flexion, hip ab/adduction, sit-to-stands, torso rotation, and marching. | Behavioural | Home Exercise Program (HEX) |
Primary outcome
Change in Short Physical Performance Battery
Time frame: Baseline, 6 weeks, 12 weeks
captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB score is based on timed measures of standing balance, walking speed, and ability to rise from a chair.
4 secondary outcomes
Change in 30-second sit-to-stand test
Time frame: Baseline, 6 weeks, 12-weeks
Change in 30-second arm curl test
Time frame: Baseline, 6 weeks, 12-weeks
Change in Grip Strength
Time frame: Baseline, 6 weeks, 12 weeks
Change in Lower Extremity Strength
Time frame: Baseline, 6 weeks, 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 4 Dec 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers outside of our study team.
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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.
Alyssa Stookey, PhD principal investigator
University of Maryland School of Medicine and Baltimore VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEX in people with Aging, run by University of Maryland, Baltimore 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 2 inclusion and 4 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 4 Dec 2024. 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 in Short Physical Performance Battery (time frame: Baseline, 6 weeks, 12 weeks). 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 4 Dec 2024.