Intermittent ClaudicationNCT05611021
Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease
A study testing Exercise in people with Intermittent Claudication and Cardiovascular Diseases, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Intermittent Claudication, Cardiovascular Diseases, Blood Pressure
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jun 2022to 20 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral arterial disease diagnosis;
- Age ≥ 40 years old;
- If a woman, be in menopause without the use of hormone replacement therapy;
- Do not be an active smoker;
- Be apt to perform exercise.
Who cannot join
- Any change in medication;
- Any health impairment that contraindicates the practice of physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study
The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.
Read the detailed description
Twenty patients with peripheral arterial disease and claudication symptoms will be recruited. The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on Borg's Subjective Perceived Exertion Scale. During the experimental conditions (walking, arm-cranking and control) blood pressure, heart rate and cerebral blood velocity will be evaluated, along with perceived exertion and affective responses. Before and after experimental conditions, vascular function, blood pressure, heart rate variability, cerebral blood velocity, subjective perceived exertion and affective responses will be evaluated.
- Conditions
- Intermittent Claudication, Cardiovascular Diseases, Blood Pressure, Endothelial Dysfunction, Peripheral Arterial Disease
- Being tested
- Exercise
- Medical subject headings
- Intermittent Claudication, Cardiovascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Three conditions will be tested: Walking, arm-cranking and control condition.
| Study group | Role | What they receive |
|---|---|---|
| Walking Condition | Experimental | In the walking condition, the patients will perform fifteen bouts of two minutes of treadmill walking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration. Receives: Behavioral: Exercise |
| Arm-Cranking Condition | Active comparator | In the arm-cranking condition, the patients will perform fifteen bouts of two minutes of arm-cranking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration. Receives: Behavioral: Exercise |
| Control Condition | Sham comparator | The control condition will consist of resting in the standing position for thirty minutes. The patients will be instructed to rest in the sitting position for two minutes at periods equivalent to the intervals from the exercise conditions, totalling sixty minutes of duration. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in vascular function post-exercise in the brachial and femoral arteries.
Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.
Measured: Change from baseline at post-intervention, after 20 minutes.
Secondary outcomes (3)
Change from baseline in blood pressure post-exercise.
Blood pressure will be measured by an automatic monitor.
Measured: Change from baseline at post-intervention, after 10 minutes.
Change from baseline in heart rate variability post-exercise.
Autonomic modulation of the cardiovascular system will be measured by the heart rate variability (HRV) technique, by a heart rate monitor valid for this function.
Measured: Change from baseline at post-intervention, after 30 minutes.
Change from baseline in cerebral blood velocity post-exercise.
Cerebral blood velocity will be measured by a transcranial doppler ultrasound.
Measured: Change from baseline at 35 minutes after the beginning of the exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start8 Jun 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on the Borg's subjective perceived exertion scale.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilia de Almeida Correia, University of Nove de Julho
- Investigators
- Marilia Correia, PhD, Principal investigator, Nove de Julho UniversityRaphael Ritti-Dias, PhD, Study chair, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611021
- Sponsor's protocol ID
- AcuteEBPAD
- Status last verified
- Mar 2025
- First submitted
- 20 Oct 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data is planned to be made available after the completion of the study, if required.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Responses to Arm-Crank Exercise on Cardiovascular Function of Patients With Peripheral Artery Disease: Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT05611021
- Acronym / sponsor ID
- AcuteEBPAD
- Conditions
- Intermittent Claudication, Cardiovascular Diseases, Blood Pressure, Endothelial Dysfunction, Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 9 Nov 2022 (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.
The aim of this study is to analyze acute responses of arm-cranking exercise on cardiovascular function of peripheral arterial disease patients and compare it to the main exercise recommendation, walking exercise.
Detailed description
Twenty patients with peripheral arterial disease and claudication symptoms will be recruited. The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on Borg's Subjective Perceived Exertion Scale. During the experimental conditions (walking, arm-cranking and control) blood pressure, heart rate and cerebral blood velocity will be evaluated, along with perceived exertion and affective responses. Before and after experimental conditions, vascular function, blood pressure, heart rate variability, cerebral blood velocity, subjective perceived exertion and affective responses will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will perform three experimental conditions, in randomized order (walking, arm-cranking and control). The exercise conditions will be composed of 15 bouts of 2 minutes exercise with an intensity equivalent to 13-15 on the Borg's subjective perceived exertion scale.
| Arm | Type | Receives |
|---|---|---|
| Walking Condition | Experimental | Behavioral: ExerciseIn the walking condition, the patients will perform fifteen bouts of two minutes of treadmill walking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration. |
| Arm-Cranking Condition | Active comparator | Behavioral: ExerciseIn the arm-cranking condition, the patients will perform fifteen bouts of two minutes of arm-cranking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration. |
| Control Condition | Sham comparator | Behavioral: ExerciseThe control condition will consist of resting in the standing position for thirty minutes. The patients will be instructed to rest in the sitting position for two minutes at periods equivalent to the intervals from the exercise conditions, totalling sixty minutes of duration. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Peripheral arterial disease diagnosis;
- Age ≥ 40 years old;
- If a woman, be in menopause without the use of hormone replacement therapy;
- Do not be an active smoker;
- Be apt to perform exercise.
Key exclusion criteria (2 listed)
- Any change in medication;
- Any health impairment that contraindicates the practice of physical exercise.
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 |
|---|---|---|
| ExerciseThree conditions will be tested: Walking, arm-cranking and control condition. | Behavioural | Arm-Cranking Condition, Control Condition, Walking Condition |
Primary outcome
Change from baseline in vascular function post-exercise in the brachial and femoral arteries.
Time frame: Change from baseline at post-intervention, after 20 minutes.
Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.
3 secondary outcomes
Change from baseline in blood pressure post-exercise.
Time frame: Change from baseline at post-intervention, after 10 minutes.
Change from baseline in heart rate variability post-exercise.
Time frame: Change from baseline at post-intervention, after 30 minutes.
Change from baseline in cerebral blood velocity post-exercise.
Time frame: Change from baseline at 35 minutes after the beginning of the exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. Individual participant data is planned to be made available after the completion of the study, if required.
Related trials for Intermittent Claudication
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
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.
Marilia Correia, PhD principal investigator
Nove de Julho University
Raphael Ritti-Dias, PhD study chair
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Intermittent Claudication and Cardiovascular Diseases, run by University of Nove de Julho at 1 site in Brazil.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in vascular function post-exercise in the brachial and femoral arteries. (time frame: Change from baseline at post-intervention, after 20 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.