Recruiting

Meal Delivery & Exercise

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04906759

Conditions

Frailty

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Meals plus exercise

Meals only

Study Details

Brief 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 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

Study ID

NCT04906759

Start date

Jul 19, 2021

Status verified date

Dec, 2024

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • homebound (normally unable to leave the home unassisted)
  • frail or prefrail by The Fried Frailty Phenotype (FFP)
  • medically stable

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Meals plus exercise

experimental: Meals only

Interventions

Meals plus exercise

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jessica Lee, MD,MS

713-500-5457Jessica.Lee@uth.tmc.edu

Paola Robles Cordova

(713) 500-7904Paola.RoblesCordova@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jessica Lee, MD,MS

(713) 500-5457Jessica.Lee@uth.tmc.edu

Paola Robles Cordova

(713) 500-7904Paola.RoblesCordova@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • homebound patients
  • exercise
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-06.