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Leg Heat Therapy for Aging

Phase 2
Recruiting
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-week follow-up
Awards & highlights

Study Summary

This trial is looking at the effects of home-based leg heat therapy on elderly sedentary individuals. The study will help to establish if the therapy can improve muscle function, walking performance and quality of life.

Who is the study for?
This trial is for sedentary individuals aged 65 or older who do not smoke and exercise less than three days a week. They must be able to fit into water-circulating trousers and complete a 6-minute walk test without the help of walking aids other than a cane. People with active cancer or those under age 65 are excluded.Check my eligibility
What is being tested?
The study tests if leg heat therapy can improve muscle size, strength, walking performance, and quality of life in elderly people. Participants will wear special trousers that circulate hot water around their legs daily for 90 minutes over 12 weeks, comparing two temperatures: therapeutic (42ºC) versus sham (33ºC).See study design
What are the potential side effects?
Potential side effects may include discomfort from the heat, skin irritation where the trousers contact the body, and possible overheating during treatment sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12-week follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Six-minute walk distance
Secondary outcome measures
Phosphocreatine
Repeated chair rises
Short-Form (SF)-36 Questionnaire
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heat therapyExperimental Treatment1 Intervention
Participants will be provided a leg heat therapy system and will be instructed to apply the therapy daily (90 min/day) for 12 consecutive weeks. The water heater will circulate water at 42ºC.
Group II: Sham controlPlacebo Group1 Intervention
Participants will be provided a leg heat therapy system and will be instructed to apply the therapy daily (90 min/day) for 12 consecutive weeks. The water heater will circulate water at 33ºC.

Find a Location

Who is running the clinical trial?

Purdue UniversityLead Sponsor
224 Previous Clinical Trials
72,744 Total Patients Enrolled
2 Trials studying Aging
65 Patients Enrolled for Aging
American College of Sports Medicine FoundationUNKNOWN
1 Previous Clinical Trials
24 Total Patients Enrolled
Indiana Clinical and Translational Sciences InstituteOTHER
19 Previous Clinical Trials
4,653 Total Patients Enrolled

Media Library

Leg Heat Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05543980 — Phase 2
Aging Research Study Groups: Heat therapy, Sham control
Aging Clinical Trial 2023: Leg Heat Therapy Highlights & Side Effects. Trial Name: NCT05543980 — Phase 2
Leg Heat Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543980 — Phase 2

Frequently Asked Questions

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

What is the current number of participants in this research endeavor?

"Indeed, the data hosted on clinicaltrials.gov confirms that this medical investigation is currently searching for participants. The study was first announced in September 5th 2022 and underwent some amendments until its most recent update of September 13th 2022. 20 individuals need to be recruited from a single institution for successful completion of the trial."

Answered by AI

Can patients use the Leg heat therapy device without fear of adverse effects?

"Based on the phase 2 trial, our experts at Power have assigned a value of 2 to the safety rating for this leg heat therapy device as there is some data reinforcing its security but none attesting to its effectiveness."

Answered by AI

Is this research currently accepting volunteers?

"Affirmative. Clinicaltrials.gov confirms that this research is currently seeking participants, having been first posted on September 5th 2022 and modified most recently on the 13th of the same month. A total of 20 volunteers are needed from a single medical centre for the study to proceed."

Answered by AI
~8 spots leftby Apr 2025