Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

NCT06178913 | Completed DMC

• 1 other identifier: 4-2023-0549
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The study goal is to develop exercise intervention methods to improve the prognosis and quality of life of patients with non-tuberculous mycobacterial lung disease and to confirm the effectiveness of exercise intervention. This prospective study is scheduled to be conducted as a pre-post single-arm feasibility trial, targeting a total of 50 subjects.

Conditions

Nontuberculous Mycobacteria

Outcome Measures

Primary Outcomes (1)

• VO2max

  The patient wears a mask that transmits inhalation and exhalation to a gas analyzer on the treadmill and a heart rate monitor that measures heart rate. The treadmill gradually increases the incline and increases the speed. When the patient runs as far as they can run and raises their hand to show the measurer, the patient's VO2max is measured by measuring the maximum amount of oxygen that can be taken in and heart rate.

  within the first 1 week (plus or minus 1 week) after the end of exercise intervention

Secondary Outcomes (16)

• The 6-Minute Walk Test

  within the first 1 week (plus or minus 1 week) after the end of exercise intervention

• 30-Second Sit-to-Stand

  within the first 1 week (plus or minus 1 week) after the end of exercise intervention

• Short Physical Performance Battery

  within the first 1 week (plus or minus 1 week) after the end of exercise intervention

• Muscular strength (Handgrip strength in kilograms)

  within the first 1 week (plus or minus 1 week) after the end of exercise intervention

• COPD Assessment Test

  within the first 1 week (plus or minus 1 week) after the end of exercise intervention

Study Arms (1)

Exercise intervention

EXPERIMENTAL

Other: Exercise intervention

Interventions

Exercise intervention OTHER

The exercise intervention method is a circuit training method that combines strength training and aerobic exercise forms and consists of a total of 12 movements. Performing movements 1 to 12 in order is 1 set. After completing the set, when the heart rate returns to the plateau (less than 59% of maximum heart rate), proceed to the next set, for a total of 3 sets.

Exercise intervention

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 80 years diagnosed with non-tuberculous mycobacterial lung disease according to the ATS/IDSA guideline, Patients with respiratory symptoms (cough, phlegm, difficulty breathing, etc.) at the time of selection, Patients who understand the purpose of the clinical study and voluntarily agree to participate in this clinical study

You may not qualify if:

• Patients diagnosed with cardiovascular disease (Angina, HFrEF, arrhythmia, history of heart valve surgery, etc.), Patients who have had massive hemoptysis within the last 3 months, Patients who have difficulty moving freely due to musculoskeletal problems (osteoarthritis, intervertebral disc herniation, spinal stenosis, etc.), Patients who cannot read the consent form (e.g. illiterate, foreigner, etc.)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 21, 2023
• Study Start: July 10, 2023
• Primary Completion: January 10, 2024
• Study Completion: February 20, 2024
• Last Updated: July 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)