FrailtyNCT04906759
Meal Delivery and Exercise
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 evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6… 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- homebound (normally unable to leave the home unassisted)
- frail or prefrail by The Fried Frailty Phenotype (FFP)
- medically stable
Who cannot join
- robust by FFP
- have Mini-Cog score <3 and/or are unable to follow instructions
- have a pre-diagnosed terminal illness
- unable to ambulate
- unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jessica Lee, MD,MS, (713) 500-5457, Jessica.Lee@uth.tmc.edu
Paola Robles Cordova, (713) 500-7904, Paola.RoblesCordova@uth.tmc.edu
About this study
Official title: A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults
The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.
- 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
Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
Meals onlyBehavioural
Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Meals plus exercise | Experimental | Not described Receives: Behavioral: Meals plus exercise |
| Meals only | Experimental | Not described Receives: Behavioral: Meals only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed
this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Score from 0(not frail),1-2(pre frail) and 3-5(frail)
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in measure of HSP70 (ng/mL) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in Measure of MIP-1β (pg/mL) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in Measure of sIL-6R (pg/mL) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
Secondary outcomes (20)
Change in 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: 4 weeks,8 weeks,12 weeks from baseline
Change in grip strength
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles .This is measured by using a dynamometer which will be squeezed by the participant 3 times in each hand.The force is measured in kilograms.
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in daily average steps from the activity tracker
Measured: 4 weeks,8 weeks,12 weeks from baseline
Number of patients that required emergency room visits
Measured: 6 months post baseline visit
Number of patients that required hospitalization
Measured: 6 months post baseline visit
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
This consists of 6 questions and each is scored form 0(patient is very dependent)-6(patient is independent)
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
This consists of 8 questions and each has a summary score range from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
This questionnaire consists of 20 questions and each is answered from 1(never)-4(always) for a total score ranging form 20-80
Measured: 4 weeks,8 weeks,12 weeks from baseline
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
LSNS-R total score is an equally weighted sum of twelve items. Scores range from 0 to 90, a higher number indicating a better outcome
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in measure of IL-6 (pg/mL) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of CRP (ng/mL) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of TNF-α (pg/mL) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of microbiome (fecal sample) expression
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in IL-6 (pg/mL) as measured by the frailty status
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in CRP (ng/mL) as measured by the frailty status
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in TNF-α (pg/mL) as measured by the frailty status
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in HSP70 (ng/mL) as measured by the frailty status
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in MIP-1β (pg/mL) as measured by the frailty status
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in sIL-6R (pg/mL) as measured by the frailty status
Measured: 4 weeks,8 weeks,12 weeks from baseline
change in microbiome (fecal sample) as measured by the frailty status
Measured: 4 weeks,8 weeks,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 posted28 May 2021
- Study start19 Jul 2021
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- 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
- NCT04906759
- Sponsor's protocol ID
- HSC-MS-21-0125
- Other IDs
- 1K23AG072042-01
- Status last verified
- Dec 2024
- First submitted
- 25 May 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults
- ClinicalTrials.gov ID
- NCT04906759
- Acronym / sponsor ID
- HSC-MS-21-0125
- Conditions
- Frailty
- Keywords
- homebound patients, exercise, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 28 May 2021 (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 purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meals plus exercise | Experimental | Behavioral: Meals plus exercise |
| Meals only | Experimental | 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)
- homebound (normally unable to leave the home unassisted)
- frail or prefrail by The Fried Frailty Phenotype (FFP)
- medically stable
Key exclusion criteria (5 listed)
- robust by FFP
- have Mini-Cog score <3 and/or are unable to follow instructions
- have a pre-diagnosed terminal illness
- unable to ambulate
- unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.
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 exerciseParticipants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers. | Behavioural | Meals plus exercise |
| Meals onlyParticipants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers. | Behavioural | Meals only |
Primary outcome
Change in gait speed
Time frame: 4 weeks,8 weeks,12 weeks from baseline
this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Score from 0(not frail),1-2(pre frail) and 3-5(frail)
Change in measure of HSP70 (ng/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in Measure of MIP-1β (pg/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in Measure of sIL-6R (pg/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
20 secondary outcomes
Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in grip strength
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in daily average steps from the activity tracker
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Number of patients that required emergency room visits
Time frame: 6 months post baseline visit
Number of patients that required hospitalization
Time frame: 6 months post baseline visit
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in measure of IL-6 (pg/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of CRP (ng/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of TNF-α (pg/mL) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Change in measures of microbiome (fecal sample) expression
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in IL-6 (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in CRP (ng/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in TNF-α (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in HSP70 (ng/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in MIP-1β (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in sIL-6R (pg/mL) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
change in microbiome (fecal sample) as measured by the frailty status
Time frame: 4 weeks,8 weeks,12 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- 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.
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 5 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: looking for participants now, as of the sponsor's last update on 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Lee, MD,MS (713-500-5457, Jessica.Lee@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed (time frame: 4 weeks,8 weeks,12 weeks from baseline). The study lists 5 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 6 Dec 2024.