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

NCT04350541 | Suspended DMC

• 1 other identifier: 07640919.4.0000.5208
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Exercise tolerance

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

  24 weeks

• Peripheral endothelial function

  Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device

  24 weeks

Secondary Outcomes (3)

• Quality of life assessment: Short Form-36 questionnaire

  24 weeks

• Perception of clinical change

  24 weeks

• Distance covered in the six-minute walk test

  24 weeks

Study Arms (2)

Interval training

EXPERIMENTAL

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

Continuous training

ACTIVE COMPARATOR

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

Interventions

High-intensity interval training OTHER

Exercise with high-intensity intervals followed by active rest

Interval training

Continuous aerobic training OTHER

Interval Moderate-intensity aerobic training without intervals

Continuous training

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist, clinical research

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 17, 2020
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 15, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)