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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
Contact:
Jessica Lee, MD,MS
(713) 500-5457
Jessica.Lee@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jessica Lee, MD,MS
713-500-5457
Jessica.Lee@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.