Meal Delivery and Exercise

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty
• Intervention / Treatment: Behavioral: Meals plus exercise; Behavioral: Meals only

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Lee, MD,MS; Phone Number: 713-500-5457; Email: Jessica.Lee@uth.tmc.edu
• Study Contact Backup: Name: Paola Robles Cordova; Phone Number: (713) 500-7904; Email: Paola.RoblesCordova@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Jessica Lee, MD,MS; Phone Number: 713-500-5457; Email: Jessica.Lee@uth.tmc.edu
      • Contact: Paola Robles Cordova; Phone Number: (713) 500-7904; Email: Paola.RoblesCordova@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meals plus exercise	Behavioral: 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.
Experimental: Meals only	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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
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)	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.	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	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	4 weeks,8 weeks,12 weeks from baseline
change in measure of IL-6 (pg/mL) expression		4 weeks,8 weeks,12 weeks from baseline
Change in measures of CRP (ng/mL) expression		4 weeks,8 weeks,12 weeks from baseline
Change in measures of TNF-α (pg/mL) expression		4 weeks,8 weeks,12 weeks from baseline
Change in measures of microbiome (fecal sample) expression		4 weeks,8 weeks,12 weeks from baseline
change in IL-6 (pg/mL) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline
change in CRP (ng/mL) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline
change in TNF-α (pg/mL) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline
change in HSP70 (ng/mL) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline
change in MIP-1β (pg/mL) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline
change in sIL-6R (pg/mL) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline
change in microbiome (fecal sample) as measured by the frailty status		4 weeks,8 weeks,12 weeks from baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jessica Lee, MD,MS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; nutrition; homebound patients
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: HSC-MS-21-0125; 1K23AG072042-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No