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Heat Therapy for Limited Mobility

Phase 1 & 2

Recruiting

Research Sponsored by University of North Texas Health Science Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 8 weeks of heat therapy or sham

Awards & highlights

Study Summary

This trial tested whether home-based leg heat therapy can help older adults stay active and improve blood flow.

Who is the study for?

This trial is for post-menopausal women aged 55 to 80 with a BMI under 35 (unless athletic), normal blood pressure, and no recent tobacco use. They must have a healthy heart rhythm and general health. Exclusions include certain medication uses, respiratory illnesses, history of severe allergies or clotting issues, cancer diagnosis, cardiovascular abnormalities, latex allergy, leg or arm skin issues.Check my eligibility

What is being tested?

The study investigates if applying heat therapy at home to the legs can improve walking ability, blood vessel health, and the body's response to exercise in older adults. Participants will either receive real heat treatment or a sham (fake) therapy as a comparison.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from the heat application on legs or possible skin irritation due to sensitivity to the heating device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 8 weeks of heat therapy or sham

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 8 weeks of heat therapy or sham

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 8 weeks of heat therapy or sham for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6 minute walk test

Blood flow response to exercise

Macrovascular function

+1 more

Secondary outcome measures

Physical performance Battery

Trial Design

2Treatment groups

Experimental Treatment

Group I: Home-based heat therapy and vascular function and exercise hyperemia in older adultsExperimental Treatment2 Interventions

The investigators will determine if home-based leg heat therapy improves vascular function and exercise hyperemia in the older adults of Aim 1. Using state-of-the-art techniques of skeletal muscle microdialysis and high-resolution duplex ultrasound, the investigators will pharmacodissect mechanisms of vascular function and exercise hyperemia before and after each intervention. The outcomes of Aim 2, while providing insight into the mechanisms whereby heat therapy improves functional capacity, should be considered independent of the outcomes of Aim 1 given that vascular health is a key independent, yet modifiable risk factor for cardiovascular morbidity and mortality.

Group II: Home-based heat therapy and functional capacity in older adultsExperimental Treatment2 Interventions

The investigators will determine the extent to which home-based leg heat therapy improves functional capacity in older adults. Functional capacity will be assessed before and after heat therapy or sham intervention via the 6-min walk test and the Short Physical Performance Battery.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of North Texas Health Science CenterLead Sponsor

39 Previous Clinical Trials

20,100 Total Patients Enrolled

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,554 Total Patients Enrolled

Media Library

Home-based leg heat therapy Clinical Trial Eligibility Overview. Trial Name: NCT05706181 — Phase 1 & 2

Hyperaemia Research Study Groups: Home-based heat therapy and functional capacity in older adults, Home-based heat therapy and vascular function and exercise hyperemia in older adults

Hyperaemia Clinical Trial 2023: Home-based leg heat therapy Highlights & Side Effects. Trial Name: NCT05706181 — Phase 1 & 2

Home-based leg heat therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05706181 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient cohort for this research trial limited to those under 60 years of age?

"This trial has a relatively narrow age range of 55 to 80. However, 3 trials are available for minors and 49 trials cater specifically to patients over the age of 65."

Answered by AI

Are enrollees still being accepted into this clinical trial?

"Affirmative. On clinicaltrials.gov, the study's initiation date is November 3rd of 2022 and it was recently revised on January 20th of this year. 72 participants are expected to be recruited at 1 trial site."

Answered by AI

How many participants have been recruited for this clinical research?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was initially published on November 3rd 2022, is currently accepting participants. The trial aims to recruit 72 patients from a single site."

Answered by AI

Who do you consider to be the ideal participants for this medical experiment?

"This research project is currently accepting applications from 72 people with a history of hyperaemia between the ages of 55 and 80. To be considered, interested parties must adhere to the following prerequisites: no nicotine consumption in 6 months prior; systolic blood pressure lower than 140 mmHg and diastolic below 90 mmHg; standard 12-lead ECG (reviewed by medical professional); satisfactory results on a clinical evaluation administered by an accredited doctor (e.g., General Health Questionnaire - see attached document); BMI under 35 unless they possess athletic/muscular bodily composition, calculated as body weight (in kilograms) divided by"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heat Therapy, Functional Capacity, and Vascular Health in Older Adults

2022. "Heat Therapy, Functional Capacity, and Vascular Health in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05706181.