Effectiveness of a Home-based Cardiovascular Rehabilitation Program Compared With Standard Care in Patients With Moderate to Severe Peripheral Artery Disease: a Pilot Randomized Controlled Trial (PILOT-PAD-CYCLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
Peripheral arterial disease (PAD) is a chronic atherosclerotic condition associated with impaired mobility, reduced quality of life, cardiovascular events, and risk of lower limb amputation. Although supervised exercise therapy (SET) is recommended for symptomatic PAD, access and adherence remain limited, particularly among patients with moderate-to-severe disease or chronic limb-threatening ischemia (CLTI).
The PILOT-PAD-CYCLE study is a prospective, single-center, pilot randomized controlled trial designed to evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week home-based exercise therapy (HET) program using a portable pedal exerciser in adults with moderate-to-severe PAD, including CLTI, with or without foot wounds.
Twelve participants will be randomized 1:1 to either HET plus standard care or standard care alone. The intervention includes individualized exercise prescription, remote supervision by a kinesiologist, cardiovascular education, and follow-up over 12 weeks. Outcomes include feasibility and acceptability metrics, 6-minute walk test distance, vascular perfusion indices, quality of life, and cardiovascular events up to 6 months.
This pilot trial aims to generate feasibility data and preliminary efficacy estimates to support the development of a future multicenter randomized controlled trial.
详细描述
Peripheral arterial disease (PAD) is a major manifestation of systemic atherosclerosis and is associated with impaired walking capacity, functional decline, cardiovascular morbidity, reduced quality of life, and increased risk of lower limb amputation. Patients with moderate-to-severe PAD and chronic limb-threatening ischemia (CLTI) represent a particularly vulnerable population with substantial mobility limitations and high rates of cardiovascular events and mortality.
Supervised exercise therapy (SET) is recommended as a first-line therapy for symptomatic PAD and has demonstrated significant benefits on walking performance, functional capacity, and quality of life. However, access to SET programs remains limited in many regions due to geographic barriers, transportation difficulties, costs, limited specialized infrastructure, and poor adherence, particularly among individuals with advanced PAD, foot wounds, frailty, or mobility impairment.
Home-based exercise therapy (HET) has emerged as a promising alternative to traditional SET. Portable pedal exercisers may provide a low-cost, accessible, and feasible exercise modality for patients unable to participate in treadmill-based rehabilitation programs. However, evidence regarding the feasibility, acceptability, and preliminary efficacy of pedal exerciser-based HET in patients with moderate-to-severe PAD or CLTI remains limited.
The PILOT-PAD-CYCLE study is a prospective, single-center, pilot randomized controlled trial conducted at Hôtel-Dieu de Lévis (Québec, Canada). The study aims to evaluate the feasibility and acceptability of a 12-week HET program using a portable pedal exerciser in adults with moderate-to-severe PAD, including patients with foot wounds.
Twelve participants will be randomized in a 1:1 ratio to either:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants, clinical staff, and research personnel will be aware of group allocation. Statistical analyses will be conducted while preserving group blinding whenever feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Moderate-to-severe peripheral arterial disease defined by at least one of the following:
- •ABI < 0.6 Ankle systolic pressure < 70 mmHg Toe systolic pressure < 40 mmHg Toe-brachial index < 0.4
- •With or without lower limb wound
- •Declined referral to an in-person supervised exercise therapy program
- •Able to provide informed consent
排除标准
- •Lower limb revascularization within the previous 30 days
- •Planned revascularization during the first 12 weeks of the study
- •Unable to use a portable pedal exerciser
- •Unable to perform a 6-minute walk test
- •Medically unstable according to the treating clinical or rehabilitation team
- •Participation in a cardiovascular rehabilitation program within the previous year
研究组 & 干预措施
Standard Care
Usual standard care delivered by their physician for peripheral artery disease
Home-based exercise therapy (HET) plus standard care
Standard care
干预措施: Home-Based Exercise Therapy Using Portable Pedal Exerciser (Behavioral)
研究者
Jérôme Patry
Principal Investigator
Laval University