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Recruiting NCT04906759

Meal Delivery and Exercise

No phase Interventional Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meals plus exercise, Meals only.
Who it may be relevant to
Registry conditions: Frailty. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults

Overview

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.

Interventions

  • 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
  • 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 h

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT04906759 · HSC-MS-21-0125 · 1K23AG072042-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗