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Meal Delivery and Exercise

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Frailty

Treatments

Behavioral: Meals only
Behavioral: Meals plus exercise

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04906759
HSC-MS-21-0125
1K23AG072042-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Meals plus exercise
Experimental group
Treatment:
Behavioral: Meals plus exercise
Meals only
Experimental group
Treatment:
Behavioral: Meals only

Trial contacts and locations

1

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Central trial contact

Paola Robles Cordova; Jessica Lee, MD,MS

Data sourced from clinicaltrials.gov

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