Self Selected Exercise Intensity in PAD Patients

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333615
• Other study ID #: SelfSelectedPAD
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: October 2022
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Nove de Julho	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brachial blood pressure	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.	Change from baseline at 30 minutes after the beginning of the exercise.
Secondary	Heart rate variability	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).	Change from baseline at post-intervention, after 20 minutes.
Secondary	Feeling Scale	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.	Change from baseline at 35 minutes after the beginning of the exercise.
Secondary	Subjective perceived effort	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.	Change from baseline at 35 minutes after the beginning of the exercise.
Secondary	Cognitive function	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.	Change from baseline at post-intervention, after 1 hour.
Secondary	Cognitive function 2	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.	Change from baseline at post-intervention, after 1 hour and 10 minutes.