Cardiovascular Effects of Pulmonary Rehabilitation in COPD

NCT03943030 | Completed

• 1 other identifier: 96766418100005327
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Chronic obstructive pulmonary disease (COPD) is characterized by airflow obstruction, which is clinically manifested by dyspnea and leads the patient to a vicious cycle of sedentary lifestyle. Pulmonary rehabilitation (PR) is an important therapeutic strategy to break this cycle. Cardiovascular diseases are frequent in patients with (COPD) and are associated with higher mortality. The effects of (PR) on cardiovascular risk factors in patients with (COPD) have been little studied so far. Objectives: To evaluate the effects of pulmonary rehabilitation compared to the control group on cardiovascular risk factors in patients with (COPD). Methods: A randomized clinical trial will be conducted. Patients with (COPD) will be divided into two groups: Group I (GI): group that will be rehabilitated, with 3 weekly sessions, for 8 weeks and Group II (GII): control group, without intervention. In both groups, a baseline evaluation will be performed, which will be repeated after 9 weeks and consists of: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI). Outcomes commonly used in the assistance to assess (PR) will also be measured. Expected Results: The study is expected to improve understanding of the impact of (PR) on cardiovascular variables in patients with (COPD).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary rehabilitation; Chronic Obstructive Pulmonary Disease; Cardiovascular effects; Endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

• Dilatation mediated by the flow of the brachial artery

  The flow-mediated dilatation of the brachial artery will be assessed non-invasively by the ultrasound device (SONOSITE®, M-Turbo, Sony). A high-frequency transducer (HFL38xp, SONOSITE®, Sony) will be used to obtain longitudinal images of the brachial artery walls.

  Eight Weeks.

Secondary Outcomes (16)

• Brachial ankle index

  Eight Weeks.

• Body-mass Index

  Eight Weeks.

• Airflow Obstruction

  Eight Weeks.

• Dyspnea - Modified Medical Research Council (mMRC scale)

  Eight Weeks.

• Exercise Capacity

  Eight Weeks.

Study Arms (2)

Pulmonary rehabilitation

EXPERIMENTAL

The PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured.

Other: Pulmonary rehabilitation

Group control

NO INTERVENTION

The group will not receive pulmonary rehabilitation intervention. Patients will be guided and maintain their daily and routine lives normally during the evaluation process. However, a baseline evaluation will be performed, which will be repeated after 9 weeks: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes commonly used in the assistance to assess PR will also be measured.

Interventions

Pulmonary rehabilitation OTHER

The PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured.

Pulmonary rehabilitation

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD;
• Stable patients (no exacerbation in the last 4 weeks).

You may not qualify if:

• Patients with contraindications to exercise (decompensated ischemic heart disease or neuromuscular diseases) or unable to perform evaluations and / or participate in the pulmonary rehabilitation program.
• Bood pressure greater than 160/90 mmHg,
• Serum cholesterol greater than 220,
• Diabetes mellitus,
• Active smoking or using vasodilator drugs (calcium channel blockers and ACE inhibitors).
• Use of β-blocker will be directed to ingest the last dose of this drug 24 hours before the measurement of endothelial function.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Marli Knorst

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial, performed with two groups: intervention and controls (usual care).

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: May 9, 2019
• Study Start: February 11, 2019
• Primary Completion: December 18, 2021
• Study Completion: July 18, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)