Skip to main content
OpenTrials
Completed

NCT Number: NCT04333615

Self Selected Exercise Intensity in PAD Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Motor Activity Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Brachial blood pressure

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

    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.

  2. Heart rate variability

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

    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).

  3. Feeling Scale

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

    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.

  4. Subjective perceived effort

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

    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.

  5. Cognitive function

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

    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.

  6. Cognitive function 2

    Time frame: Change from baseline at post-intervention, after 1 hour and 10 minutes.

    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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Effects of Self-selected Walking Exercise Intensity on Adherence, Functional Capacity and Cardiovascular Risk Indicators in Patients With Peripheral Artery Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.