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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exercise Training for Patients With Poor Leg Circulation

NCT00118560

Diabetes Mellitus, Type 2 Intermittent Claudication

COMPLETED NA

Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients

NCT04759469

Diabetes Mellitus, Type 2

COMPLETED NA

Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women

NCT04488341

Coagulation Disorder

UNKNOWN NA

Local or Systemic Effects: Mechanisms Related to Arm Crank Exercise - Comparison Between Individuals With and Without PAD

NCT06828172

Peripheral Arterial Disease

ENROLLING_BY_INVITATION NA

Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women

NCT06271798

Varicose Veins

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group(A)

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

Group Type ACTIVE_COMPARATOR

Cycle

Intervention Type DEVICE

Kettler upright bike Giro P:

Group(B)

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

Group Type ACTIVE_COMPARATOR

Cycle

Intervention Type DEVICE

Kettler upright bike Giro P:

Group(C)

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

Group Type ACTIVE_COMPARATOR

Cycle

Intervention Type DEVICE

Kettler upright bike Giro P:

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cycle

Kettler upright bike Giro P:

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes