Clinical trial NCT04333615: Self Selected Exercise Intensity in PAD Patients
Official title: Effects of Self-selected Walking Exercise Intensity on Adherence, Functional Capacity and Cardiovascular Risk Indicators in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Peripheral artery disease
Exercise
Cerebral blood flow
Cardiovascular system
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2020-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Cerebral perfusion
timeFrame: Change from baseline at 30 minutes after the beginning of the exercise.
Secondary outcomes:
measure: Brachial blood pressure
timeFrame: Change from baseline at 30 minutes after the beginning of the exercise.
measure: Heart rate variability
timeFrame: Change from baseline at post-intervention, after 20 minutes.
measure: Feeling Scale
timeFrame: Change from baseline at 35 minutes after the beginning of the exercise.
measure: Subjective perceived effort
timeFrame: Change from baseline at 35 minutes after the beginning of the exercise.
measure: Cognitive function
timeFrame: Change from baseline at post-intervention, after 1 hour.
measure: Cognitive function 2
timeFrame: Change from baseline at post-intervention, after 1 hour and 10 minutes.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Raphael M Ritti Dias, PhD
role: PRINCIPAL_INVESTIGATOR
References: