Nontuberculous MycobacteriaNCT06178913
Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease
A study testing Exercise intervention in people with Nontuberculous Mycobacteria, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Nontuberculous Mycobacteria
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: Improving Prognosis and Evaluating Patient Experience Through Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease
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.
Read the detailed description
- After confirming the intention to participate in the study for patients with non-tuberculous mycobacterial lung disease who meet the selection criteria, basic personal information and clinical history information are collected.
- When three people are recruited, they are organized into one group and begin a four-week exercise program. A total of 17 groups will be recruited and 50 people will be registered, and within 1 week before and after the start of the exercise program, VO2 max, physical function (6MWT, 30s sit to stand, SPPB, Handgrip strength), Baseline PFT, Laboratory test, Quality of life test (QOL) -B, CAT) is performed.
- Once a week for 4 weeks, full-body strength training and aerobic exercise are performed for 60 minutes with an exercise expert (supervised exercise), and the remaining 6 days a week are home-based exercises, in which the subject exercises independently at home. Write it down in participants exercise diary.
- VO2 max, physical function (6MWT, 30s sit to stand, SPPB, handgrip strength), PFT, laboratory test, and quality of life test (QOL-B, CAT) are conducted again within one week before and after the exercise intervention is completed.
- Conditions
- Nontuberculous Mycobacteria
- Being tested
- Exercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Not described Receives: Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Secondary outcomes (16)
The 6-Minute Walk Test
The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
30-Second Sit-to-Stand
The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Short Physical Performance Battery
The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Muscular strength (Handgrip strength in kilograms)
The 6-Minute Walk Test, 30-Second Sit-to-Stand, Short Physical Performance Battery, and Muscular Strength (Handgrip strength in kilograms) are employed to assess the physical ability of our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
COPD Assessment Test
The COPD Assessment Test and the Quality of Life-Bronchiectasis (QOL-B) questionnaire are used for evaluating the quality of life in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
the Quality of Life-Bronchiectasis (QOL-B) questionnaire
The COPD Assessment Test and the Quality of Life-Bronchiectasis (QOL-B) questionnaire are used for evaluating the quality of life in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
forced vital capacity in percent
Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
forced expiratory volume exhaled in the first second in percent
Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
a forced expiratory volume in 1 s/forced vital capacity ratio in percent
Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
bronchodilator response in percent
Forced vital capacity in percent, forced expiratory volume exhaled in the first second in percent, the forced expiratory volume in 1 s/forced vital capacity ratio in percent, and bronchodilator response in percent are utilized to evaluate lung function in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
WBC count per microliter
WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
hemoglobin in gram per deciliter
WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Albumin in gram per deciliter
WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
CRP in miligram per liter
WBC count per microliter, hemoglobin in grams per deciliter, albumin in grams per deciliter, and CRP in milligrams per liter are used to assess inflammation, nutrition, and anemia status in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Body fat mass in kilogram
Body fat mass in kilograms and skeletal muscle mass in kilograms are used to assess the amount of fat and muscle in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
skeletal muscle mass in kilogram
Body fat mass in kilograms and skeletal muscle mass in kilograms are used to assess the amount of fat and muscle in our study participants.
Measured: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start10 Jul 2023
- Primary completion10 Jan 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous MycobacteriaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178913
- Sponsor's protocol ID
- 4-2023-0549
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prognosis and Evaluating Patient Experience Through Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06178913
- Acronym / sponsor ID
- 4-2023-0549
- Conditions
- Nontuberculous Mycobacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- After confirming the intention to participate in the study for patients with non-tuberculous mycobacterial lung disease who meet the selection criteria, basic personal information and clinical history information are collected.
- When three people are recruited, they are organized into one group and begin a four-week exercise program. A total of 17 groups will be recruited and 50 people will be registered, and within 1 week before and after the start of the exercise program, VO2 max, physical function (6MWT, 30s sit to stand, SPPB, Handgrip strength), Baseline PFT, Laboratory test, Quality of life test (QOL) -B, CAT) is performed.
- Once a week for 4 weeks, full-body strength training and aerobic exercise are performed for 60 minutes with an exercise expert (supervised exercise), and the remaining 6 days a week are home-based exercises, in which the subject exercises independently at home. Write it down in participants exercise diary.
- VO2 max, physical function (6MWT, 30s sit to stand, SPPB, handgrip strength), PFT, laboratory test, and quality of life test (QOL-B, CAT) are conducted again within one week before and after the exercise intervention is completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Other: Exercise intervention |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionThe 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. | Other | Exercise intervention |
Primary outcome
VO2max
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
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.
16 secondary outcomes
The 6-Minute Walk Test
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
30-Second Sit-to-Stand
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Short Physical Performance Battery
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Muscular strength (Handgrip strength in kilograms)
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
COPD Assessment Test
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
the Quality of Life-Bronchiectasis (QOL-B) questionnaire
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
forced vital capacity in percent
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
forced expiratory volume exhaled in the first second in percent
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
a forced expiratory volume in 1 s/forced vital capacity ratio in percent
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
bronchodilator response in percent
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
WBC count per microliter
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
hemoglobin in gram per deciliter
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Albumin in gram per deciliter
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
CRP in miligram per liter
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Body fat mass in kilogram
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
skeletal muscle mass in kilogram
Time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Nontuberculous Mycobacteria, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: within the first 1 week (plus or minus 1 week) after the end of exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.