Self Selected Exercise Intensity in PAD Patients

NCT ID: NCT04333615

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-10-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Session

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.

Group Type: SHAM_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

Self-selected Session

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Walking with pain

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• do not finish three experimental sessions;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Raphael Mendes Ritti Dias

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raphael M Ritti Dias, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

Universidade Nove de Julho

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 40990702 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37646619 (View on PubMed)

Other Identifiers

SelfSelectedPAD

Identifier Type: -

Identifier Source: org_study_id