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NCT03288181
Effects of Passive Muscle Stretching on Vascular Function and Symptoms of PAD
NA trial testing Muscle Stretch in Peripheral Arterial Disease in 13 participants. Completed in 15 June 2016.
30 May 2016
Quick facts
| Lead sponsor | Tallahassee Research Institute, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 5 October 2015 |
| Primary completion | 30 May 2016 |
| Estimated completion | 15 June 2016 |
Drugs / interventions tested
- Muscle Stretch
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
- Claudication — all drugs for Claudication →
Sponsor
Tallahassee Research Institute, Inc.
Who can join
Eligibility, any sex, with Peripheral Arterial Disease or Claudication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with peripheral arterial disease often have walking impairment due to insufficient oxygen supply to lower extremity skeletal muscle. In an aging rat model, we have previously shown that daily calf muscle stretching improves endothelium-dependent dilation of soleus muscle arterioles and blood flow during exercise. The effect of muscle stretching on endothelial function and walking distance in patients with peripheral arterial disease is unknown. We performed a prospective, randomized, non-blinded, crossover study in 13 patients with stable symptomatic peripheral artery disease. Patients were randomized to undergo either 4 weeks of passive calf muscle stretching (ankle dorsiflexion splints applied 30 minutes/day, 5 days/week) followed by 4 weeks of no muscle stretching (control group) and vice versa. Endothelium-dependent flow-mediated dilation and endothelium- independent nitroglycerin-induced dilation of the popliteal artery and a 6 minute walk test were evaluated at baseline and after each 4 week treatment interval. Patients crossed over to the other treatment arm after 4 weeks and endothelium-dependent flow-mediated dilation and endothelium- independent nitroglycerin-induced dilation of the popliteal artery and the 6 minute walk test were repeated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03288181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Tallahassee Research Institute, Inc. trials
Trials by the same sponsor.
- NCT03271177 — Ultrasound Comparison of Radial Artery Hyperplasia After Use of a 7F Sheathless Guide vs. 6F Sheath/Guide Combination · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03288181 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tallahassee Research Institute, Inc.
- Last refreshed: 19 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03288181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing