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NCT04222751 · ClinicalTrials.gov registry record · NA
Static Muscular Stretching for Treatment of PAD
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04222751 is a NA study that has completed, run by Florida State University. The registered enrollment target is 21 participants.
The verdict
NCT04222751, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.
Interventions
- DEVICE Ankle Splint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04222751
The ClinicalTrials.gov registry entry for NCT04222751 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ankle Splint is the first listed.
NCT04222751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04222751 about?
NCT04222751 is a clinical study titled "Static Muscular Stretching for Treatment of PAD". Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the pu...
What is the current status of trial NCT04222751?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2020-07-29. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT04222751?
The interventions under investigation include: Ankle Splint (DEVICE).
Who is sponsoring clinical trial NCT04222751?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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