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NCT05543980 · ClinicalTrials.gov registry record · Phase 1
Leg Heat Therapy in Elderly Individuals
A Phase 1 study, sponsored by Purdue University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05543980 is a Phase 1 study that has completed, run by Purdue University. The registered enrollment target is 24 participants.
The verdict
NCT05543980, a Phase 1 study, has completed, sponsored by Purdue University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This pilot randomized, sham-controlled trial aimed to establish the feasibility and safety of home-based leg HT in community-dwelling older adults and inform the design of a future, larger study. Participants were randomized to either an HT or a sham group and were asked to apply the treatment daily for 90 min over 12 consecutive weeks. The primary outcomes were compliance with the HT regimen, measured by a hidden timer, completion rates, and device safety. The secondary goals were to examine the effects of leg HT on 6-min walk distance, sit-to-stand performance, blood pressure, quality of life, and the morphology and strength of the calf muscles, as assessed using combined T1-weighted and mDixon magnetic resonance imaging (MRI). Building upon previous findings in young individuals, preclinical models of PAD, and older individuals with PAD, we hypothesized that older adults treated with leg HT for 12 weeks would display improved walking performance, increased calf strength, and reduced intramuscular fat when compared to sham-treated individuals.
Interventions
- DEVICE Sham device
- DEVICE Leg heat therapy device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-09-05 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05543980
The ClinicalTrials.gov registry entry for NCT05543980 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham device is the first listed.
NCT05543980 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05543980 about?
NCT05543980 is a clinical study titled "Leg Heat Therapy in Elderly Individuals". This pilot randomized, sham-controlled trial aimed to establish the feasibility and safety of home-based leg HT in community-dwelling older adults and inform the design of a future, larger study. Participants were randomized to either an HT or a sham group and were asked to apply the treatment daily...
What is the current status of trial NCT05543980?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-09-05. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT05543980?
The interventions under investigation include: Sham device (DEVICE), Leg heat therapy device (DEVICE).
Who is sponsoring clinical trial NCT05543980?
This trial is sponsored by Purdue University, which has 141 total clinical trials registered on ClinicalTrials.gov.
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