Cardiopulmonary Function and Quality of Life in Pulmonary Tuberculosis

NCT04844502 | Active Not Recruiting DMC

• 1 other identifier: 10481219.9.0000.5257
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This work aims to assess cardiopulmonary function and quality of life in people with sequelae of pulmonary tuberculosis undergoing rehabilitation. It is an experimental clinical study, with evaluation before and after the intervention. Included participants will be randomized and divided into a control group and an intervention group. Quality of life is examined by two questionnaires and physical fitness by specific tests, before and after the intervention. The intervention is the realization of a supervised physical exercise protocol.

Conditions

Tuberculosis, Pulmonary; Physical Disability; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Physical Capacity

  Comparison between a physical capacity evaluation

  9 months

Secondary Outcomes (1)

• Quality of Life reported

  9 months

Study Arms (2)

Control Group

NO INTERVENTION

Frequent life activities.

Intervention Group

EXPERIMENTAL

Protocol of physical exercises

Other: Physical rehabilitation

Interventions

Physical rehabilitation OTHER

Rehabilitation can be applied to the intervention group in two ways: in person or by home orientation. The face-to-face form will correspond to 5 weeks of intervention, 3 sessions per week, which should include: a) aerobic resistance training of 30 minutes in total, five minutes of cooling down); b) strengthening of peripheral muscles using 20-minute sessions of calisthenic exercises; and c) maintained active stretching, for 10 minutes, for the main muscle groups. The home-based intervention will correspond to three months of daily activities, monitored twice a week in the first month and once a week in the second and third months, by telephone or video conference, and will follow an exercise protocol that includes: a) aerobic resistance training for 15 uninterrupted minutes; b) anaerobic training to strengthen the peripheral muscles for 15 minutes at intervals with breathing exercises; and c) maintained active stretching, for 10 minutes, for the main muscle groups.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Pulmonary Tuberculosis,
• negative culture in induced sputum;
• pulmonary function report (spirometry), chest X-ray and complete blood count with biochemistry updated in the last month,
• in accordance with the Informed Consent Form.

You may not qualify if:

• Non-cooperative patients,
• clinical instability and / or musculoskeletal injury that compromises Pulmonary Rehabilitation and limits the perception of physical capacity;
• comorbidities that may cause or accentuate dyspnea (Asthma, COPD, Pulmonary Fibrosis, Obesity);
• stable angina, severe arrhythmias and / or heart failure.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

University Hospital

Rio de Janeiro, Rio de Janeiro, 21941-617, Brazil

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diego de Faria Magalhães Torres

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 14, 2021
• Study Start: April 7, 2021
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)