Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease

NCT06488495 | Recruiting DMC

• 1 other identifier: 4-2024-0147
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1.objective Evaluation of effectiveness and safety of exercise intervention program for patients with non-tuberculous mycobacterial pulmonary disease 2. background Nontuberculous mycobacterial pulmonary disease (NTM-PD) is a chronic respiratory infection that generally affects individuals with structural lung diseases, such as chronic obstructive pulmonary disease (COPD) and bronchiectasis and without structural lung disease. The prevalence of NTM-PD is increasing worldwide , which has caused public health concerns because of environmental exposure to nontuberculous mycobacteria (NTM) and chronic intractable diseases. Pulmonary rehabilitation is essential to the non-pharmacological treatment of chronic respiratory diseases. Positive effects of exercise training have been demonstrated in COPD and bronchiectasis. However, there are limited data on the effectiveness and safety of exercise program for patients with non-tuberculous mycobacterial pulmonary disease 3. design 1\) Prospective, single-center, randomized, open-label, two-group clinical study 2) Patients eligible for the study are randomly assigned 1:1 4. group

• 40-80 years old
• culture positive within 6months
• with respiratory symptoms 7. Outcome measure
• primary outcome : Oxygen uptake max
• secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker

Conditions

Nontuberculous Mycobacterial Pulmonary Disease

Keywords

NTM; Pulmonary Disease; Exercise

Outcome Measures

Primary Outcomes (1)

• VO2max, maximal oxygen consumption

  VO2max will be measured in baseline, after 6-week exercise program in the intervetion arm and baseline, before exercise program, and after 6-week exercise program in the control arm. The difference of VO2 max between the group will be assessed.

  Immediate intervention group : 1) before exercise program (baseline) 2) after 6-week exerrcise program 3) after 6 month of exercise program

Secondary Outcomes (32)

• physical function

  Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)

• physical function

  Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)

• physical function

  Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)

• physical function

  Delayed intervention group : 1) Baseline 2) Pre-evaluation (before exercise program), 3) Post-evaluation ( after 6-week exercise program), 4) long-term evaluation ( after 6months of exercise program)

• physical function

  Immediate intervention group : 1) Baseline (before exercise program), 2) Post-evaluation ( after 6-week exercise program), 3) long-term evaluation ( after 6months of exercise program)

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

Participants receive the exercise intervention immediately after randomization

Behavioral: Exercise Program

Delayed Intervention Group

OTHER

Participants receive the exercise intervention immediately after enrollment.

Behavioral: Exercise Program

Interventions

Exercise Program BEHAVIORAL

The exercise intervention includes a six-week program with weekly supervised sessions and daily home-based exercises.

Immediate Intervention Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 40-80 diagnosed with NTM pulmonary disease.
• Present respiratory symptoms.
• Positive NTM culture within the last 6 months.
• Voluntary consent to participate.

You may not qualify if:

• Diagnosed with cardiovascular disease.
• Recent major hemoptysis.
• Musculoskeletal issues preventing free movement.
• Unable to read the consent form.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; 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: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 5, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

KR (1)