Effect of Single-versus Double-limb Cycling Exercise on Blood Flow in Patients With Peripheral Artery Disease

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Peripheral Arterial Disease

Treatments: Device: Cycle

Study type: Interventional

Funder types: Other

Identifiers

NCT06518590

cyling on blood flow in PAD

Details and patient eligibility

About

This study will be conducted to investigate the effect of single limb cycling exercise and the effect of double limb cycling exercise on blood flow in patients with peripheral artery disease and compare between both effects.

Full description

Global populations are undergoing a major epidemiological transition in which the burden of atherosclerotic cardiovascular diseases is shifting rapidly from high-income to low-income and middle-income countries (LMICs). Peripheral artery disease (PAD) is no exception, so that greater focus is now required on the prevention and management of this disease in less-advantaged countries (Gerry et al., 2017) PAD prevalence and incidence are both sharply age-related, rising >10% among patients in their 60s and 70s. With the aging of the global population, it seems likely that PAD will be increasingly common in the future. Prevalence seems to be higher among men than women for more severe or symptomatic disease (Michael et al., 2015).

PAD causes leg pain, impaired health-related quality of life, immobility, tissue loss and a high risk of major adverse events, including myocardial infarction, stroke, revascularization, amputation and death. The drug cilostazol, exercise therapy and revascularization are the current treatment options for the limb symptoms of PAD, but each has limitations (Jonathan et al., 2022) Few studies conducted the importance of active and passive movements and aerobic exercises for Cardiovascular especially peripheral artery disease patients as mentioned previously, thus the aim of this study is to conduct single limb cycling exercise and double limbs cycling exercise to PAD patient to determine the effect of cycling on blood flow velocity and which is more effective and leads to more benefits compared to the control group.

Enrollment: 75 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Mild to moderate PAD ( ABI ranges from less than 0.90 to 0.50) 2. Intermittent claudication / Typical claudication 3. Their age will be ranged from 50_60 years old. 4. Quitting smoking for more than 3 months 5. Body mass index (BMI) from 25.0 to 29.9kg/m2.

Exclusion criteria

• 1. Patients with uncontrolled pulmonary disease. 2. Patients with vascular severe complication as critical limb ischemia(ABI less than 0.5) 3. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.

  2. Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).

  3. Any patients who missed more than two weeks of the program or want to terminate the program.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Group(A)

Active Comparator group

Description:

Twenty five patients will receive unilateral limb training sequentially (counter weighted single limb cycling ) (dominant limb, then non-dominant limb) by bicycle for 20-30 minutes per session, three sessions per week for 2 months (8 weeks), in addition to health advices and their medications

Treatment:

Device: Cycle

Group(B)

Active Comparator group

Description:

Twenty-five patients will receive bilateral limbs training by bicycle for 20_ 30 minutes per session, three sessions per week for 2 months (8 weeks), in addition to health advices and their medications

Treatment:

Device: Cycle

Group(C)

Active Comparator group

Description:

Twenty five patients will receive medications in addition to health advices.

Treatment:

Device: Cycle