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

NCT06518590 | Not Yet Recruiting Phase 1

• 1 other identifier: cyling on blood flow in PAD
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Blood flow velocity by Doppler

  Blood 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 .

  baseline

Secondary Outcomes (3)

• Functional capacity test (6 Min walk test )

  baseline

• The ankle -brachial index test

  baseline

• Walking impairment questionnaire

  baseline

Study Arms (3)

Group(A)

ACTIVE COMPARATOR

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

Device: Cycle

Group(B)

ACTIVE COMPARATOR

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

Device: Cycle

Group(C)

ACTIVE COMPARATOR

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

Device: Cycle

Interventions

Cycle DEVICE

Kettler upright bike Giro P:

Group(A); Group(B); Group(C)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.
• \. Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).
• \. Any patients who missed more than two weeks of the program or want to terminate the program.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Firnhaber JM, Powell CS. Lower Extremity Peripheral Artery Disease: Diagnosis and Treatment. Am Fam Physician. 2019 Mar 15;99(6):362-369.

  PMID: 30874413 BACKGROUND

• Bevan GH, White Solaru KT. Evidence-Based Medical Management of Peripheral Artery Disease. Arterioscler Thromb Vasc Biol. 2020 Mar;40(3):541-553. doi: 10.1161/ATVBAHA.119.312142. Epub 2020 Jan 30.

  PMID: 31996023 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Merna Marwan Mohamed, B.Sc.

CONTACT

01117948467; merna.abuzahra@gmail.com

Ahmad MAHDI AHMED, Assistant Professor

CONTACT

01007056624; Ahmed.mahdy@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: July 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07