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

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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06518590
Enrollment
75
Registered
2024-07-24
Start date
2024-07-31
Completion date
2024-12-31
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief summary

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.

Detailed 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.

Interventions

DEVICECycle

Kettler upright bike Giro P:

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood flow velocity by DopplerbaselineBlood flow (velocity) and circulation: which will be measured by the doppler ultrasonogrophy at the begining and at the end of the study. \- Doppler ultrasonogrophy of the lower extremity arteries, from common femoral to pedal arteries peak systolic velocity (PSV) recorded in meters per second (Ugwu.,et al .,2021 ) .The normal peak systolic velocity (PSV ) in peripheral lower limb arteries varies from 45-180 cm/s . Severe arterial disease manifests as a PSV in excess of 200 cm/s , monophasic waveform and spectral broading of the doppler wave form .

Secondary

MeasureTime frameDescription
Functional capacity test (6 Min walk test )baselineFunctional capacity which will be : measured by a Six min walk test before and after the program of exercising according to the American Thoracic Society 113, TECHNICAL ASPECTS OF THE 6MWT (at the beginning and at the end of the study).
The ankle -brachial index testbaselinewhich will be measured by Duplex at the beginning and at the end of the program of exercising
Walking impairment questionnairebaselineWalking impairment questionnaire: An effective tool to assess the effect of treatment in patients with intermittent claudication. WIQ is a valid tool to detect improvement or deterioration in the daily walking ability of patients with intermittent claudication.

Contacts

Primary ContactMerna Marwan Mohamed, B.Sc.
merna.abuzahra@gmail.com01117948467
Backup ContactAhmad MAHDI AHMED, Assistant Professor
Ahmed.mahdy@pt.cu.edu.eg01007056624

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026