Peripheral Arterial DiseasePhase 1/2NCT06518590
Effect of Single-versus Double-limb Cycling Exercise on Blood Flow in Patients With Peripheral Artery Disease
A Phase 1/2 study testing Cycle in people with Peripheral Arterial Disease, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Cycle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Cycle
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CycleDevice
Kettler upright bike Giro P:
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Cycle |
| Group(C) | Active comparator | Twenty five patients will receive medications in addition to health advices. Receives: Device: Cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: baseline
Secondary outcomes (3)
Functional capacity test (6 Min walk test )
Functional 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).
Measured: baseline
The ankle -brachial index test
which will be measured by Duplex at the beginning and at the end of the program of exercising
Measured: baseline
Walking impairment questionnaire
Walking 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Marwan Mohamed Kamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518590
- Sponsor's protocol ID
- cyling on blood flow in PAD
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Firnhaber JM, Powell CS. Lower Extremity Peripheral Artery Disease: Diagnosis and Treatment. Am Fam Physician. 2019 Mar 15;99(6):362-369.
PubMed 30874413Bevan 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.
PubMed 31996023
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single-versus Double-limb Cycling Exercise on Blood Flow in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT06518590
- Acronym / sponsor ID
- cyling on blood flow in PAD
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group(A) | Active comparator | Device: CycleTwenty 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(B) | Active comparator | Device: CycleTwenty-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(C) | Active comparator | Device: CycleTwenty five patients will receive medications in addition to health advices. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CycleKettler upright bike Giro P: | Device | Group(A), Group(B), Group(C) |
Primary outcome
Blood flow velocity by Doppler
Time frame: baseline
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 .
3 secondary outcomes
Functional capacity test (6 Min walk test )
Time frame: baseline
The ankle -brachial index test
Time frame: baseline
Walking impairment questionnaire
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 30874413Firnhaber JM, Powell CS. Lower Extremity Peripheral Artery Disease: Diagnosis and Treatment. Am Fam Physician. 2019 Mar 15;99(6):362-369.
- Background: PubMed 31996023Bevan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cycle in people with Peripheral Arterial Disease, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merna Marwan Mohamed, B.Sc. (01117948467, merna.abuzahra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow velocity by Doppler (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06518590, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.