Exercise Program in Patients With Nontuberculous Mycobacterial Pulmonary Disease
NCT Number: NCT06488495
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nontuberculous Mycobacterial Pulmonary Disease
Interventions: BEHAVIORAL: Exercise Program|BEHAVIORAL: Exercise Program
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-24
Completion Date: 2027-04-01
Locations: Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

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

1. arm 1 : immediate exercise intervention group Exercise intervention will begin immediately after randomization.
2. arm 2 : delayed intervention group : Exercise intervention will begin 6 weeks after randomization.

5. intervention

1) 6-week exercise program : one-day hospital-based education, 5-day home-based exercise 6. Participants :

1) patients with nontuberculous mycobacterial pulmonary disease

* 40-80 years old
* culture positive within 6months
* with respiratory symptoms 7. Outcome measure

  1. primary outcome : Oxygen uptake max
  2. secondary outcome : 6MWT(six-minute walk test), quality of life, pulmonary function, body composition, inflammatory marker

Primary Outcome Measures: 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 Outcome Measures: physical function, 6min walk test will be measured in both intervention arm and control arm (delayed intervention group)., 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, 6min walk test will be measured in both intervention arm and control arm (delayed intervention group)., 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, 30second sit to stand will be measured in both intervention arm and control arm (delayed intervention group)., 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, 30second sit to stand will be measured in both intervention arm and control arm (delayed intervention group)., 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, Short physical performance battery (SPPB) will be measured in both intervention arm and control arm (delayed intervention group)., 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, Short physical performance battery (SPPB) will be measured in both intervention arm and control arm (delayed intervention group)., 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, global physical activity Questionnaire (GPAQ) : According to the GPAQ analysis guidelines, the metabolic equivalent of task (MET) min per week after assigning MET values (four METs for moderate intensity and eight METs for vigorous intensity) to incorporate the intensity of PA will be calculated. The score of less than 600 classifies the subject as inactive; a score of 600 or more classifies the subject as active., 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, global physical activity Questionnaire (GPAQ) : According to the GPAQ analysis guidelines, the metabolic equivalent of task (MET) min per week after assigning MET values (four METs for moderate intensity and eight METs for vigorous intensity) to incorporate the intensity of PA will be calculated. The score of less than 600 classifies the subject as inactive; a score of 600 or more classifies the subject as active., 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)|Quality of Life, Body composition will be measured by bioimpedance analysis using an InBody 770 device (Biospace, Seoul, Republic of Korea). Skeletal muscle mass, appendicular skeletal muscle mass, fat mass, fat free mass will be measured. Sarcopenia was diagnosed when patients also exhibited low appendicular skeletal muscle mass divided by height squared (\<7.0 kg/m2 for males and \<5.7 kg/m2 for females). Adipopenia was defined when the fat mass index (FMI) was below the lower limit of the normal range (\<3 kg/m2 for males and \<5 kg/m2 for females), based on a study examining normal FMI in a Korean population, 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)|Quality of Life, Body composition will be measured by bioimpedance analysis using an InBody 770 device (Biospace, Seoul, Republic of Korea). Skeletal muscle mass, appendicular skeletal muscle mass, fat mass, fat free mass will be measured. Sarcopenia was diagnosed when patients also exhibited low appendicular skeletal muscle mass divided by height squared (\<7.0 kg/m2 for males and \<5.7 kg/m2 for females). Adipopenia was defined when the fat mass index (FMI) was below the lower limit of the normal range (\<3 kg/m2 for males and \<5 kg/m2 for females), based on a study examining normal FMI in a Korean population, 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)|Quality of Life, COPD assessment test (CAT) :The score will range from 0 to 40. Higher scores indicate COPD has a greater impact on the QOL., 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)|Quality of Life, COPD assessment test (CAT) The score will range from 0 to 40. Higher scores indicate COPD has a greater impact on the QOL., 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)|Quality of Life, Quality of Life Questionnaire-Bronchiectasis (QOL-B) :Score will range from 0 to 100. Higher scores indicate COPD has a greater impact on the QOL. Higher scores indicate high QOL., 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)|Quality of Life, Quality of Life Questionnaire-Bronchiectasis (QOL-B) : Score will range from 0 to 100. Higher scores indicate COPD has a greater impact on the QOL. Higher scores indicate high QOL., 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)|Quality of Life, Hospital anxiety and depression scale (HDAS) :The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The scale distinguishes between mild symptoms (≥8) and severe symptoms (≥11) of depression or anxiety., 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)|Quality of Life, Hospital anxiety and depression scale (HDAS) : The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). The scale distinguishes between mild symptoms (≥8) and severe symptoms (≥11) of depression or anxiety., 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)|Pulmonary Function, PFT(pulmonary function test), 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)|Pulmonary Function, PFT(pulmonary function test), 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)|Pulmonary Function, FVC(forced vital capacity), 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)|Pulmonary Function, FVC(forced vital capacity), 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)|Pulmonary Function, FEV1(forced expiratory, 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)|Pulmonary Function, FEV1(forced expiratory, 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)|Biochemical inflammatory marker, CBC(complete blood count), 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)|Biochemical inflammatory marker, CBC(complete blood count), 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)|Biochemical inflammatory marker, Albumin, 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)|Biochemical inflammatory marker, Albumin, 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)|Biochemical inflammatory marker, CRP(C reactive protein), 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)|Biochemical inflammatory marker, CRP(C reactive protein), 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)|Biochemical inflammatory marker, ESR(erythrocyte), 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)|Biochemical inflammatory marker, ESR(erythrocyte), 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)|Body composition and handgrip strength, Body composition and handgrip strength be measured in both intervention arm and control arm(delayed intervention group).

Handgrip strength be measured in both intervention arm and control arm(delayed intervention group.

Handgrip strength will be measured using Digital Grip Dynamometer TKK5401. Based on the criteria suggested by the Asian Working Group for Sarcopenia, handgrip strength was categorized into two groups: low handgrip strength, \< 28 kg for male and \< 18 kg for female; and normal handgrip strength, ≥ 28 kg for male and ≥ 18 kg for female, 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)|Body composition and handgrip strength, Body composition and handgrip strength be measured in both intervention arm and control arm(delayed intervention group).

Handgrip strength be measured in both intervention arm and control arm(delayed intervention group.

Handgrip strength will be measured using Digital Grip Dynamometer TKK5401. Based on the criteria suggested by the Asian Working Group for Sarcopenia, handgrip strength was categorized into two groups: low handgrip strength, \< 28 kg for male and \< 18 kg for female; and normal handgrip strength, ≥ 28 kg for male and ≥ 18 kg for female, 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)