Meals plus exercise for Frailty

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TXFrailty+6 MoreMeals plus exercise - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Frailty

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Enhanced Implementation (EI)
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Metformin
2
Lifestyle therapy

Study Objectives

5 Primary · 20 Secondary · Reporting Duration: 6 months post baseline visit

Week 12
Change in Measure of MIP-1β (pg/mL) expression
Change in Measure of sIL-6R (pg/mL) expression
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 gait speed
Change in grip strength
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
Change in measure of HSP70 (ng/mL) expression
Change in measures of CRP (ng/mL) expression
Change in measures of TNF-α (pg/mL) expression
Change in measures of microbiome (fecal sample) expression
Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
change in CRP (ng/mL) as measured by the frailty status
change in HSP70 (ng/mL) as measured by the frailty status
change in IL-6 (pg/mL) as measured by the frailty status
change in MIP-1β (pg/mL) as measured by the frailty status
change in TNF-α (pg/mL) as measured by the frailty status
change in measure of IL-6 (pg/mL) expression
change in microbiome (fecal sample) as measured by the frailty status
change in sIL-6R (pg/mL) as measured by the frailty status
Month 6
Number of patients that required emergency room visits
Number of patients that required hospitalization

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Enhanced Implementation (EI)
2
Metformin
3
Lifestyle therapy

Trial Design

2 Treatment Groups

Meals plus exercise
1 of 2
Meals only
1 of 2

Experimental Treatment

64 Total Participants · 2 Treatment Groups

Primary Treatment: Meals plus exercise · No Placebo Group · N/A

Meals plus exercise
Behavioral
Experimental Group · 1 Intervention: Meals plus exercise · Intervention Types: Behavioral
Meals only
Behavioral
Experimental Group · 1 Intervention: Meals only · Intervention Types: Behavioral
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

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post baseline visit

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
820 Previous Clinical Trials
259,440 Total Patients Enrolled
1 Trials studying Frailty
9 Patients Enrolled for Frailty
National Institute on Aging (NIA)NIH
1,452 Previous Clinical Trials
4,280,114 Total Patients Enrolled
17 Trials studying Frailty
10,925 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

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are considered physically weak or vulnerable according to the Fried Frailty Phenotype scale.
You are in good health condition.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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