FrailtyNCT04087343
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
A study testing Meals plus exercise and Meals only in people with Frailty, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Meals plus exercise and Meals only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolled in UT-Health Harris Health House Call Program (HCP)
- Frail or pre frail by FFP
- medically stable
Who cannot join
- robust by FFP
- Mini-Cog score <3 and/or are unable to follow instructions
- pre-diagnosed terminal illness
- unable to ambulate,and/or are unable to use their upper extremities
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults.
- Conditions
- Frailty
- Being tested
- Meals plus exercise, Meals only
- Keywords
- homebound patients, exercise, nutrition
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meals plus exerciseBehavioural
Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
Meals onlyBehavioural
Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Meals plus exercise | Experimental | Not described Receives: Behavioral: Meals plus exercise |
| Meals only | Active comparator | Not described Receives: Behavioral: Meals only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
Measured: baseline
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
Measured: 12 weeks after study initiation
Secondary outcomes (12)
Levels of Plasma Vitamin C
Measured: baseline
Levels of Plasma Vitamin C
Measured: 12 weeks from baseline
Levels of Serum Folate
Measured: Baseline
Levels of Serum Folate
Measured: 12 weeks from baseline
Levels of Vitamin B12
Measured: Baseline
Levels of Vitamin B12
Measured: 12 weeks from baseline
Levels of Vitamin 25-OHD
Measured: Baseline
Levels of Vitamin 25-OHD
Measured: 12 weeks from baseline
Levels of Methylmalonic Acid (MMA)
Measured: Baseline
Levels of Methylmalonic Acid (MMA)
Measured: 12 weeks from baseline
Levels of Homocysteine (HCy)
Measured: Baseline
Levels of Homocysteine (HCy)
Measured: 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start18 Sep 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Jessica Lee, The University of Texas Health Science Center, Houston
- Investigators
- Jessica Lee, MD,MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087343
- Sponsor's protocol ID
- HSC-MS-19-0191
- Other IDs
- KL2TR003168
- Status last verified
- Jan 2023
- First submitted
- 10 Sep 2019
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
- ClinicalTrials.gov ID
- NCT04087343
- Acronym / sponsor ID
- HSC-MS-19-0191
- Conditions
- Frailty
- Keywords
- homebound patients, exercise, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meals plus exercise | Experimental | Behavioral: Meals plus exercise |
| Meals only | Active comparator | Behavioral: Meals only |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- enrolled in UT-Health Harris Health House Call Program (HCP)
- Frail or pre frail by FFP
- medically stable
Key exclusion criteria (4 listed)
- robust by FFP
- Mini-Cog score <3 and/or are unable to follow instructions
- pre-diagnosed terminal illness
- unable to ambulate,and/or are unable to use their upper extremities
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 |
|---|---|---|
| Meals plus exercisePatients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study. | Behavioural | Meals plus exercise |
| Meals onlyPatients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study. | Behavioural | Meals only |
Primary outcome
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Time frame: baseline
The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Time frame: 12 weeks after study initiation
The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.
12 secondary outcomes
Levels of Plasma Vitamin C
Time frame: baseline
Levels of Plasma Vitamin C
Time frame: 12 weeks from baseline
Levels of Serum Folate
Time frame: Baseline
Levels of Serum Folate
Time frame: 12 weeks from baseline
Levels of Vitamin B12
Time frame: Baseline
Levels of Vitamin B12
Time frame: 12 weeks from baseline
Levels of Vitamin 25-OHD
Time frame: Baseline
Levels of Vitamin 25-OHD
Time frame: 12 weeks from baseline
Levels of Methylmalonic Acid (MMA)
Time frame: Baseline
Levels of Methylmalonic Acid (MMA)
Time frame: 12 weeks from baseline
Levels of Homocysteine (HCy)
Time frame: Baseline
Levels of Homocysteine (HCy)
Time frame: 12 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jessica Lee, MD,MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals plus exercise and Meals only in people with Frailty, run by The University of Texas Health Science Center, Houston 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 3 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 8 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. (time frame: baseline). The study lists 2 primary outcomes in all. 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 8 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.