Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD

Sponsor
Universidade Federal de Pernambuco (Other)
Overall Status
Suspended
CT.gov ID
NCT04350541
Collaborator
(none)
40
1
2
27.5
1.5

Study Details

Study Description

Brief Summary

INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.

Condition or Disease Intervention/Treatment Phase
  • Other: High-intensity interval training
  • Other: Continuous aerobic training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Heart Failure Associated With Chronic Obstructive Lung Disease and Maximum Exercise Tolerance: Evaluation of the Distribution and Pulmonary Deposition of Radioaerosol, Peripheral and Coronary Endothelial Function, Brain Natriuretic Peptide
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interval training

Interval training will consist of 10 minutes of warm-up between 40-50% of the peak oxygen consumption (VO2peak), followed by four to six repetitions of three-minute intervals between 80-90% of VO2peak and three minutes between 40-50% VO2peak and finally, five minutes of cooling down between 30-40% of VO2peak.

Other: High-intensity interval training
Exercise with high-intensity intervals followed by active rest

Active Comparator: Continuous training

The continuous aerobic training will consist of 10 minutes of warm-up with intensity between 40 and 50% of VO2peak, 20 minutes of conditioning between 60 and 70% of VO2peak and 5 minutes of cooling down between 30 and 40% of VO2peak.

Other: Continuous aerobic training
Interval Moderate-intensity aerobic training without intervals

Outcome Measures

Primary Outcome Measures

  1. Exercise tolerance [24 weeks]

    Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.

  2. Peripheral endothelial function [24 weeks]

    Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device

Secondary Outcome Measures

  1. Quality of life assessment: Short Form-36 questionnaire [24 weeks]

    Evaluated by the Short Form-36 questionnaire

  2. Perception of clinical change [24 weeks]

    Evaluated by the Patient Global Impression of Change Scale which is a one-dimensional measure in which individuals can rate their associated improvement on a 7-item scale ranging from "1 = no changes" to "7 = much better".

  3. Distance covered in the six-minute walk test [24 weeks]

    Evaluated by the six-minute walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Sedentary individuals with Heart Failure of all etiologies;

  • Diagnosed moderate and severe chronic obstructive pulmonary disease;

  • Clinical stability;

  • No change in the medication class within three months before the beginning of the research.

Exclusion Criteria:
  • Unstable angina;

  • Myocardial infarction;

  • Previous cardiac surgery up to three months before the beginning of the study;

  • Hemodynamic instability;

  • Orthopedic and neurological diseases;

  • Psychological and/or mental impairment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Pernambuco Recife Pernambuco Brazil 50740-560

Sponsors and Collaborators

  • Universidade Federal de Pernambuco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BRUNA THAYS SANTANA DE ARAƚJO, physiotherapist, clinical research, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT04350541
Other Study ID Numbers:
  • 07640919.4.0000.5208
First Posted:
Apr 17, 2020
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021