Meal Delivery and Exercise

NCT04906759 | Recruiting DMC

• 2 other identifiers: HSC-MS-21-01251K23AG072042-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

homebound patients; exercise; nutrition

Outcome Measures

Primary Outcomes (5)

• 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

  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)

  4 weeks,8 weeks,12 weeks from baseline

• Change in measure of HSP70 (ng/mL) expression

  4 weeks,8 weeks,12 weeks from baseline

• Change in Measure of MIP-1β (pg/mL) expression

  4 weeks,8 weeks,12 weeks from baseline

• Change in Measure of sIL-6R (pg/mL) expression

  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

  4 weeks,8 weeks,12 weeks from baseline

• Change in grip strength

  4 weeks,8 weeks,12 weeks from baseline

• Change in daily average steps from the activity tracker

  4 weeks,8 weeks,12 weeks from baseline

• Number of patients that required emergency room visits

  6 months post baseline visit

• Number of patients that required hospitalization

  6 months post baseline visit

Study Arms (2)

Meals plus exercise

EXPERIMENTAL

Behavioral: Meals plus exercise

Meals only

EXPERIMENTAL

Behavioral: Meals only

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 plus exercise

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.

Meals only

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Meals; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jessica Lee, MD,MS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Lee, MD,MS

CONTACT

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

Paola Robles Cordova

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: July 19, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)