Self Selected Exercise Intensity in PAD Patients

NCT04333615 | Completed

• 1 other identifier: SelfSelectedPAD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Peripheral artery disease; Exercise; Cerebral blood flow; Cardiovascular system

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at 30 minutes after the beginning of the exercise.

Secondary Outcomes (6)

• Brachial blood pressure

  Change from baseline at 30 minutes after the beginning of the exercise.

• Heart rate variability

  Change from baseline at post-intervention, after 20 minutes.

• Feeling Scale

  Change from baseline at 35 minutes after the beginning of the exercise.

• Subjective perceived effort

  Change from baseline at 35 minutes after the beginning of the exercise.

• Cognitive function

  Change from baseline at post-intervention, after 1 hour.

Study Arms (3)

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.

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.

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Three conditions will be tested: self-selected exercise, walking with pain exercise, and control session.

Control Session; Self-selected Session; Walking with pain

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• do not finish three experimental sessions;

Sponsors & Collaborators

• University of Nove de Julho: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Location

Related Publications (2)

• 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.

  PMID: 40990702 DERIVED

• de 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.

  PMID: 37646619 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Raphael M Ritti Dias, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: April 3, 2020
• Study Start: September 1, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)