Effects of a Pulmonary and Cardiovascular Rehabilitation Program

January 11, 2025 updated by: Letícia Baltieri, University of Campinas, Brazil
Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease.
  • Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation.
  • Referral with medical clearance for rehabilitation

Exclusion Criteria:

  • Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise
Other: Exercise
effect of exercise after three months (comparison of the patient with himself)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: three months
The Six-Minute Walk Test (6MWT) is used to measure functional capacity. For the test, the study participant walks in a flat 30-meter corridor for 6 minutes and the evaluator marks the final distance covered. This distance is normalized according to age and individual anthropometric characteristics in a solution validated in the literature. This distance represents the functional capacity that can be within or below that predicted by the literature.
three months
Inspiratory muscle strength
Time Frame: three months
Using an analog manometer, inspiratory muscle strength was assessed by means of maximum inspiratory pressure (MIP) in cmH2O. During this procedure, the patient was comfortably seated in a chair with his/her feet flat on the floor and, using a nose clip, was instructed to take a maximal deep inspiration into the mouthpiece of the device after a complete exhalation. The average of three dimensions was recorded. Both the absolute value of the estimates and the predicted value according to the literature were recorded using the following equations according to Neder et al., 1999
three months
Expiratory muscle strength
Time Frame: three months
Using an analog manometer, exspiratory muscle strength was assessed by means of maximum inspiratory pressure (MEP) in cmH2O. During this procedure, the patient was comfortably seated in a chair with his/her feet flat on the floor and, using a nose clip, was instructed to take a maximal deep expiration into the mouthpiece of the device after a complete inspiration. The average of three dimensions was recorded. Both the absolute value of the estimates and the predicted value according to the literature were recorded using the following equations according to Neder et al., 1999
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: three months
We will use the St. George's Respiratory Questionnaire or SF-36
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2019

Primary Completion (Actual)

November 3, 2024

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.004.580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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