Meal Delivery and Exercise

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04906759
Status
Recruiting
Apply to this trial

Conditions

  • Frailty

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Meals plus exercise — BEHAVIORAL
    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 only — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Jul 19, 2021
Status verified
Dec 2024
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Meals plus exercise
  • Experimental: Meals only

Primary Outcome Measure

Change in gait speed [ Time Frame: 4 weeks,8 weeks,12 weeks from baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Jessica Lee, MD,MS
[email protected]
(713) 500-5457
Paola Robles Cordova
[email protected]
(713) 500-7904

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