Structured Home-based Exercise Versus Walking Advice in Claudication

Status Active, not recruiting

Clinical Trial Summary

A recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (PAD) and claudication to be implemented in real-world care. This randomized-controlled trial aims to test the effects on mobility, hemodynamics and cardiovascular outcomes of a structured home-based exercise program (SHB) compared to walking advice (WA) recommendation intended as usual care, in PAD patients. Male and females PAD patients at Leriche-Fontaine's stage II and aged more than 60 years old will be enrolled. Patients will be randomized in SHB or WA groups. Patients of SHB group will receive a prescription of a home-based walking program during serial testing sessions at the hospital. The program will include two 10-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. Two follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence and to update the exercise program by increasing the walking speed. Patients randomized in WA group will receive the advice to walk as suggested by the guidelines. In particular, patients will be recommended to gather almost 30 minutes of walking at least 3 times per week; when they will face claudication pain, they will be allowed to rest and restart walking as soon as possible. Outcome measures will be performed at the entry prior to randomization, at the end of exercise programs (6-month) and after 12-month follow up. Primary outcomes will be the pain-free walking distance and the 6-minute walking distance collected during the 6-minute walking test Secondary outcomes will include ankle-brachial index, quality of life, lower limb strength and long-term clinical outcomes including revascularization and mortality.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04751890
Study type	Interventional
Source	University Hospital of Ferrara
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 1, 2021
Completion date	December 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04534257` - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Completed	`NCT02554266` - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed	`NCT03921905` - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting	`NCT06369350` - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion	Early Phase 1
Not yet recruiting	`NCT05063474` - Microvascular Reactivity in Peripheral Artery Disease
Recruiting	`NCT04545268` - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance	N/A
Recruiting	`NCT02389023` - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery	N/A
Completed	`NCT02522884` - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries	N/A
Completed	`NCT02542267` - In-Stent Restenosis Post-Approval Study	N/A
Completed	`NCT02539940` - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed	`NCT02563535` - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia	Phase 4
Completed	`NCT02262949` - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System	N/A
Completed	`NCT02228564` - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease	N/A
Completed	`NCT02145065` - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)	N/A
Completed	`NCT01743872` - Optical Imaging Measurement of Intravascular Solution Efficacy Trial	N/A
Recruiting	`NCT01424020` - Walking Estimated Limitation Calculated by History - Study 2	Phase 4
Active, not recruiting	`NCT01597453` - NOR-SYS: The Norwegian Stroke in the Young Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms