Peripheral Artery DiseaseNCT04333615
Self Selected Exercise Intensity in PAD Patients
A study testing Exercise in people with Peripheral Artery Disease, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Although the benefits of supervised walking training in patients with peripheral arterial disease (PAD) and symptoms of intermittent claudication (IC) are well established, one of the main problems found in this type of protocol is low adherence to training, which is possibly related to pain during training. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Artery Disease
- 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
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2021to 3 Oct 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral artery disease in one or both limbs (ankle brachial index <0.9);
- Claudication symptoms in six-minute walking test;
- who can walk at least 90 meters without interruption;
- that have physical conditions to perform the exercise sessions;
Who cannot join
- do not finish three experimental sessions;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Self-selected Walking Exercise Intensity on Adherence, Functional Capacity and Cardiovascular Risk Indicators in Patients With Peripheral Artery Disease
Although the benefits of supervised walking training in patients with peripheral arterial disease (PAD) and symptoms of intermittent claudication (IC) are well established, one of the main problems found in this type of protocol is low adherence to training, which is possibly related to pain during training. In addition, little is known about the impact of performing exercise with pain on cerebral blood flow and cardiovascular health indicators. Thus, the objective of the present study will be to analyze the acute effects of walking exercise with self-selected intensity on the cardiovascular health indicators of patients with PAD. Therefore, 17 patients with PAD will undergo three experimental sessions: exercise with self-selected intensity, exercise until maximum pain and control. The responses of the cardiovascular variables (heart rate variability, blood pressure, heart rate, arterial stiffness and endothelial function) will be obtained before and after the sessions. In addition, during the session cardiovascular responses (cerebral blood flow, blood pressure and heart rate), perceptual and affective responses, as well as information about the exercises performed during the session will be obtained. The responses before and after exercise will be analyzed using the two-way analysis of variance for repeated measures (ANOVA) and the Newman-Keuls post-hoc test. The value of P <0.05 will be considered significant.
- Conditions
- Peripheral Artery Disease
- Being tested
- Exercise
- Keywords
- Peripheral artery disease, Exercise, Cerebral blood flow, Cardiovascular system
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
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: self-selected exercise, walking with pain exercise, and control session.
| Study group | Role | What they receive |
|---|---|---|
| Control Session | Sham comparator | The control session will consist of resting on the treadmill for 30 min. It will be recommended that the patient do cycles in which he / she stands for 3 to 5 minutes and sits for 2 to 3 minutes in between, aiming to minimize the effect of body positioning on cardiovascular responses. Receives: Behavioral: Exercise |
| Self-selected Session | Experimental | In the self-selected exercise session, individuals will perform 30 min of exercise with self-selected intensity. This means that the duration of the series and the intensity (speed) of the treadmill are at the discretion of the patient. The important thing is that in the end it totals 30 minutes of exercise. This choice of intensity and duration of the series can be made regardless of the occurrence of pain. Receives: Behavioral: Exercise |
| Walking with pain | Active comparator | In the exercise until maximum pain session (current recommendation of walking exercise prescription for patients with PAD), individuals will perform series of 3 to 5 minutes with adjusted intensity so that they feel moderate to maximum pain. This means that the patient will start walking and the Physical Education professional, experienced and able to prescribe exercises for patients with PAD, will adjust the treadmill speed so that the patient walks with moderate pain or even maximum pain. There will be rest intervals of 2 to 3 minutes. The patient will be encouraged to complete a total of 30 minutes of exercise. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral perfusion
The cerebral perfusion at rest will be obtained by a transcranial doppler (TCD, Spencer Technologies, United States). To this end, patients will wear a helmet (Marc 600; Spencer Technologies, United States) capable of bilaterally attaching two 2 MHz ultrasound probes to the temporal window. With a method similar to that of an extracranial doppler, the transcranial doppler is capable of capturing the speeds of brain flows. The flow velocities of the middle cerebral artery will be measured bilaterally for 5 minutes, with patients at rest.
Measured: Change from baseline at 30 minutes after the beginning of the exercise.
Secondary outcomes (6)
Brachial blood pressure
Blood pressure will be obtained continuously by the Finometer blood pressure monitor (Finapress Medical System, Netherlands) using the beat-to-beat finger occlusion photoplethysmography technique.
Measured: Change from baseline at 30 minutes after the beginning of the exercise.
Heart rate variability
Heart rate variability will be assessed in order to estimate the autonomic modulation of the cardiovascular system. Therefore, after 20 minutes of rest, patients will remain in the supine position for 10 minutes, during which time RR intervals will be recorded, using a heart rate monitor valid for this function (V8000, Polar Electro, Finland).
Measured: Change from baseline at post-intervention, after 20 minutes.
Feeling Scale
A feeling scale is a single-item scale with a 11-point bipolar dimensional model, ranging from +5 to -5, commonly used to measure affective valence (pleasure / displeasure) during exercise.
Measured: Change from baseline at 35 minutes after the beginning of the exercise.
Subjective perceived effort
The perceived effort will be evaluated using the scale adapted from subjective perception of effort (0-10 points). The perceived effort will be defined as the intensity of effort, tension and subjectively perceived fatigue that the individual feels during the exercise.
Measured: Change from baseline at 35 minutes after the beginning of the exercise.
Cognitive function
Moca is a screening instrument were evaluating seven cognitive domains of a person and had the score between 0 and 30, where 0 is the worst score and 30 the best one. The domains will be: Visuospatial/executive functions, verbal memory, registration and learning, naming, 5-minute delayed verbal memory, attention, abstraction and orientation. A experienced researcher will explain how cognitive testes work and will apply to the patient.
Measured: Change from baseline at post-intervention, after 1 hour.
Cognitive function 2
The Stroop test is an important tool to the assessment of the cognitive flexibility, cognitive inhibition, selective attention and information processing speed of the patient. The test consists in three phases, the first one is naming time of nonconflicting stimuli (naming colors of colored square), the second one is naming time of conflicting (where naming colors words that are printed in a different color than their meaning). The third one is to name colors of color words printed in a different color. An experienced researcher will explain how cognitive testes work and will apply to the patient.
Measured: Change from baseline at post-intervention, after 1 hour and 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Sep 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
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 Artery DiseaseStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael M Ritti Dias, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333615
- Sponsor's protocol ID
- SelfSelectedPAD
- Status last verified
- Oct 2022
- First submitted
- 17 Feb 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveira MD, Kanegusuku H, Faria DRG, Pecanha TO, Wolosker N, Correia MA, Ritti-Dias RM. Post-exercise effects of self-selected exercise intensity on cardiovascular parameters in peripheral artery disease: a randomized crossover study. Einstein (Sao Paulo). 2025 Sep 19;23:eAO1498. doi: 10.31744/einstein_journal/2025AO1498. eCollection 2025.
PubMed 40990702de Oliveira MD, Kanegusuku H, de Faria DRG, Wolosker N, Correia MA, Ritti-Dias RM. Walking Intensity Preference of Patients With Peripheral Arterial Disease. J Cardiopulm Rehabil Prev. 2024 Jan 1;44(1):71-72. doi: 10.1097/HCR.0000000000000823. Epub 2023 Aug 30. No abstract available.
PubMed 37646619
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-selected Walking Exercise Intensity on Adherence, Functional Capacity and Cardiovascular Risk Indicators in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04333615
- Acronym / sponsor ID
- SelfSelectedPAD
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral artery disease, Exercise, Cerebral blood flow, Cardiovascular system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 3 Apr 2020 (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.
Although the benefits of supervised walking training in patients with peripheral arterial disease (PAD) and symptoms of intermittent claudication (IC) are well established, one of the main problems found in this type of protocol is low adherence to training, which is possibly related to pain during training. In addition, little is known about the impact of performing exercise with pain on cerebral blood flow and cardiovascular health indicators. Thus, the objective of the present study will be to analyze the acute effects of walking exercise with self-selected intensity on the cardiovascular health indicators of patients with PAD. Therefore, 17 patients with PAD will undergo three experimental sessions: exercise with self-selected intensity, exercise until maximum pain and control. The responses of the cardiovascular variables (heart rate variability, blood pressure, heart rate, arterial stiffness and endothelial function) will be obtained before and after the sessions. In addition, during the session cardiovascular responses (cerebral blood flow, blood pressure and heart rate), perceptual and affective responses, as well as information about the exercises performed during the session will be obtained. The responses before and after exercise will be analyzed using the two-way analysis of variance for repeated measures (ANOVA) and the Newman-Keuls post-hoc test. The value of P <0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Session | Sham comparator | Behavioral: ExerciseThe control session will consist of resting on the treadmill for 30 min. It will be recommended that the patient do cycles in which he / she stands for 3 to 5 minutes and sits for 2 to 3 minutes in between, aiming to minimize the effect of body positioning on cardiovascular responses. |
| Self-selected Session | Experimental | Behavioral: ExerciseIn the self-selected exercise session, individuals will perform 30 min of exercise with self-selected intensity. This means that the duration of the series and the intensity (speed) of the treadmill are at the discretion of the patient. The important thing is that in the end it totals 30 minutes of exercise. This choice of intensity and duration of the series can be made regardless of the occurrence of pain. |
| Walking with pain | Active comparator | Behavioral: ExerciseIn the exercise until maximum pain session (current recommendation of walking exercise prescription for patients with PAD), individuals will perform series of 3 to 5 minutes with adjusted intensity so that they feel moderate to maximum pain. This means that the patient will start walking and the Physical Education professional, experienced and able to prescribe exercises for patients with PAD, will adjust the treadmill speed so that the patient walks with moderate pain or even maximum pain. There will be rest intervals of 2 to 3 minutes. The patient will be encouraged to complete a total of 30 minutes of exercise. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Peripheral artery disease in one or both limbs (ankle brachial index <0.9);
- Claudication symptoms in six-minute walking test;
- who can walk at least 90 meters without interruption;
- that have physical conditions to perform the exercise sessions;
Key exclusion criteria (1 listed)
- do not finish three experimental sessions;
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: self-selected exercise, walking with pain exercise, and control session. | Behavioural | Control Session, Self-selected Session, Walking with pain |
Primary outcome
Cerebral perfusion
Time frame: Change from baseline at 30 minutes after the beginning of the exercise.
The cerebral perfusion at rest will be obtained by a transcranial doppler (TCD, Spencer Technologies, United States). To this end, patients will wear a helmet (Marc 600; Spencer Technologies, United States) capable of bilaterally attaching two 2 MHz ultrasound probes to the temporal window. With a method similar to that of an extracranial doppler, the transcranial doppler is capable of capturing the speeds of brain flows. The flow velocities of the middle cerebral artery will be measured bilaterally for 5 minutes, with patients at rest.
6 secondary outcomes
Brachial blood pressure
Time frame: Change from baseline at 30 minutes after the beginning of the exercise.
Heart rate variability
Time frame: Change from baseline at post-intervention, after 20 minutes.
Feeling Scale
Time frame: Change from baseline at 35 minutes after the beginning of the exercise.
Subjective perceived effort
Time frame: Change from baseline at 35 minutes after the beginning of the exercise.
Cognitive function
Time frame: Change from baseline at post-intervention, after 1 hour.
Cognitive function 2
Time frame: Change from baseline at post-intervention, after 1 hour and 10 minutes.
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 20 Oct 2022.
- Derived from this study: PubMed 40990702Oliveira MD, Kanegusuku H, Faria DRG, Pecanha TO, Wolosker N, Correia MA, Ritti-Dias RM. Post-exercise effects of self-selected exercise intensity on cardiovascular parameters in peripheral artery disease: a randomized crossover study. Einstein (Sao Paulo). 2025 Sep 19;23:eAO1498. doi: 10.31744/einstein_journal/2025AO1498. eCollection 2025.
- Derived from this study: PubMed 37646619de Oliveira MD, Kanegusuku H, de Faria DRG, Wolosker N, Correia MA, Ritti-Dias RM. Walking Intensity Preference of Patients With Peripheral Arterial Disease. J Cardiopulm Rehabil Prev. 2024 Jan 1;44(1):71-72. doi: 10.1097/HCR.0000000000000823. Epub 2023 Aug 30. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Peripheral Artery Disease
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
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.
Raphael M Ritti Dias, PhD principal investigator
University of Nove de Julho
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 Peripheral Artery Disease, 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 4 inclusion and 1 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 20 Oct 2022. 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?
Cerebral perfusion (time frame: Change from baseline at 30 minutes after the beginning of the exercise.). 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 NCT04333615, 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 20 Oct 2022.