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Meal Delivery + Exercise for Frailty
N/A
Recruiting
Led By Jessica Lee, MD,MS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Homebound (normally unable to leave the home unassisted)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post baseline visit
Awards & highlights
Study Summary
This trial will test whether a home-based exercise program can improve frailty status and gait speed in older adults. Additionally, it will examine how well established and novel frailty biomarkers correlate with each other.
Who is the study for?
This trial is for homebound older adults who are medically stable but frail or prefrail according to The Fried Frailty Phenotype. Participants must be able to walk, follow instructions, and not be in any other physical therapy programs or have terminal illnesses.Check my eligibility
What is being tested?
The study is testing the impact of a home-based exercise program delivered with Meals on Wheels on walking speed and frailty status. It also examines changes in specific blood markers related to inflammation and stress before and after exercising.See study design
What are the potential side effects?
Since this trial involves meals and exercise, side effects may include muscle soreness, fatigue from increased activity, potential dietary changes due to new meal plans, and possible falls or injuries from exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I usually can't leave my home without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post baseline visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post baseline visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Measure of MIP-1β (pg/mL) expression
Change in Measure of sIL-6R (pg/mL) expression
Change in gait speed
+2 moreSecondary outcome measures
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
Change in daily average steps from the activity tracker
Change in grip strength
+17 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Meals plus exerciseExperimental Treatment1 Intervention
Group II: Meals onlyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meals plus exercise
2019
N/A
~10
Meals only
2019
N/A
~10
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,913 Total Patients Enrolled
1 Trials studying Frailty
9 Patients Enrolled for Frailty
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,979 Total Patients Enrolled
21 Trials studying Frailty
11,269 Patients Enrolled for Frailty
Jessica Lee, MD,MSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Frailty
9 Patients Enrolled for Frailty
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may have trouble understanding or following instructions.I cannot walk on my own.I cannot use my arms or I am in physical or occupational therapy.I usually can't leave my home without help.My health condition is currently stable.
Research Study Groups:
This trial has the following groups:- Group 1: Meals plus exercise
- Group 2: Meals only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved in this medical experiment?
"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical trial is actively recruiting participants, with the initial posting date being July 19th 2021 and last updated March 9th 2022. 64 individuals are sought from a single center for participation in the study."
Answered by AI
Is this trial currently seeking new participants?
"According to clinicaltrials.gov, this trial is still recruiting participants with the earliest post-date being July 19th 2021 and most recent update occurring on March 9th 2022."
Answered by AI
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