Self Selected Exercise Intensity in PAD Patients

University of Nove de Julho

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04333615

SelfSelectedPAD

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

20 participants in 3 patient groups

Control Session

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Exercise

Self-selected Session

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Walking with pain

Active Comparator group

Description:

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.

Treatment:

Behavioral: Exercise