Chronic Obstructive Pulmonary DiseaseNCT06389734
Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF
A study testing Manual soft tissue release, Myofascial release and Exercise training in people with Chronic Obstructive Pulmonary Disease and Manual Soft Tissue Release, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Manual Soft Tissue Release, Exercise Training
- What is being tested?
- Manual soft tissue release, Myofascial release and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2023to 2 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOLD grade II~IV
- Stable condition
- No acute exacerbations in 6 weeks
Who cannot join
- Acute heart failure and, or arrhythmia
- Pulmonary arterial hypertension
- Skeletal and, or neuromuscular disorders
- Chest surgery
- Untreated or uncontrolled conditions
- Rheumatoid conditions
- Depends on oxygen supply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Combining Manual Soft Tissue Release and Physical Exercise Training on Lung Function(LF), Exercise Capacity(EC), and Cardiac Autonomic Function(CAF) in Moderate to Severe COPD: A Randomized Controlled Trial
The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) commonly presents with accessory respiratory muscle tightness and weakness, affecting chest wall compliance and lung elasticity. However, traditional physical therapy interventions, including pursed-lip breathing, sputum clearance techniques, and respiratory muscle training, are often used in treatment guidelines, with few studies focusing on muscle release for the accessory respiratory muscles. Although the effects of manual therapy on lung function and chest tightness in COPD have been demonstrated, the effects of soft tissue release combined with exercise intervention on COPD, including lung function, exercise capacity, and cardiac autonomic function, remain unknown. Therefore, this study proposes a randomized controlled trial to investigate the effects of manual soft tissue release combined with exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with COPD. It is expected that the results of this study will demonstrate that combining manual soft tissue release with exercise training may increase gas exchange in the lungs, reduce respiratory effort, improve co-morbidities, delay disease progression, and enhance patient quality of life and clinical intervention.
- Conditions
- Chronic Obstructive Pulmonary Disease, Manual Soft Tissue Release, Exercise Training, Lung Function, Exercise Capacity, Cardiac Autonomic Function
- Being tested
- Manual soft tissue release, Myofascial release, Exercise training
- Keywords
- chronic obstructive pulmonary disease, manual soft tissue release, exercise training, lung function, exercise capacity, cardiac autonomic function, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual soft tissue releaseBehavioural
The manual soft tissue release includes muscle energy techniques and passive stretching, targeting the anterior scalene, upper trapezius, pectoralis major, pectoralis minor, and diaphragm.
Three times a week for six weeks, with three rounds per session, each session having three repetitions, with a 30-second break in between, lasting 15 to 30 seconds each time.
Myofascial releaseBehavioural
The myofascial release includes suboccipital muscle, anterior chest wall myofascial, and anterior neck myofascial.
Three times a week for six weeks, with three rounds per session, each session having three repetitions, with a 30-second break in between, lasting 15 to 30 seconds each time.
Exercise trainingBehavioural
The exercise training includes aerobic exercise training by treadmill. The initial intensity is set at 60% to 85% of the average speed measured during the patient's six-minute walk test (6MWT). Intensity adjustments will be made using the Modified Borg Scale (scores ranging from 4 to 7). Training duration is 30 minutes, three times a week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive combining manual soft tissue release and exercise training. Receives: Behavioral: Manual soft tissue release; Behavioral: Exercise training |
| Control group | Active comparator | The control group will receive combining myofascial release and exercise training. Receives: Behavioral: Myofascial release; Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 s (FEV1)
FEV1 is measured by the lung function test, and the unit presented will be in percent and liter.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
forced vital capacity (FVC)
FVC is measured by the lung function test, and the unit presented will be in percent and liter.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
FEV1/FVC ratio
FEV1/FVC ratio is measured by the lung function test, and the unit presented will be in percent.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
expiratory reserve volume (ERV)
ERV is measured by the lung function test, and the unit presented will be in liter.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
functional residual capacity (FRC)
FRC is measured by the lung functions test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
inspiratory capacity (IC)
IC is measured by the lung functions test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
inspiratory reserve volume (IRV),
IRV is measured by the lung functions test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
residual volume (RV)
RV is measured by the lung function test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
total lung capacity (TLC)
TLC is measured by the lung function test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
tidal volume (TV)
TV is measured by the lung function test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
vital capacity (VC)
VC is measured by the lung function test, and the unit presented will be in liters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
Secondary outcomes (14)
Rate of perceived exertion (RPE)
RPE is measured by the cardiopulmonary exercise test. This scale ranges from 0 (very light activity) to 10 (maximum effort activity).
Measured: Change from baseline (0 week) to follow-up (12 weeks)
Oxygen consumption (VO2)
VO2 is measured by the cardiopulmonary exercise test, and the unit presented will be in milliliters of oxygen consumed per minute (ml/min).
Measured: Change from baseline (0 week) to follow-up (12 weeks)
oxygen saturation
oxygen saturation is measured by the oximeter, and the unit presented will be in percent
Measured: Change from baseline (0 week) to follow-up (12 weeks)
heart rate (HR)
HR is measured by cardiopulmonary exercise test, and the unit presented will be in beat per minute (BPM)
Measured: Change from baseline (0 week) to follow-up (12 weeks)
blood pressure (BP)
BP is measured by the cardiopulmonary exercise test, which is divided into two parameters: systolic blood pressure (SBP) and diastolic blood pressure (DBP).
The unit presented will be in millimeters of mercury (mmHg).
Measured: Change from baseline (0 week) to follow-up (12 weeks)
Diaphragmatic mobility
Diaphragmatic mobility is measured by the ultrasound, and the unit presented will be in millimeters
Measured: Change from baseline (0 week) to follow-up (12 weeks)
Cardiac Autonomic Function
Cardiac Autonomic Function is measured by heart rate variability of electrocardiography, and the unit presented will be in millisecond (ms) and millisecond square (ms2)
Measured: Change from baseline (0 week) to follow-up (12 weeks)
six minute walk test (6-MWT)
6-MWT assesses the distance a person can walk within 6 minutes, and the unit presented will be in meters.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
maximal expiratory pressure (MEP)
MEP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O).
Measured: Change from baseline (0 week) to follow-up (12 weeks)
maximal inspiratory pressure (MIP)
MIP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O).
Measured: Change from baseline (0 week) to follow-up (12 weeks)
St. George's Respiratory Questionnaire (SGRQ)
SGRQ is assessing how obstructive airway disease affects overall health, daily life, and well-being. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
fatigue severity scale (FSS)
FSS is assessing the impact of fatigue on a person's activity and lifestyle. There are nine items, and each item is scored from 1 to 9 (strongly disagree to strongly agree).
Higher total scores indicate more severe fatigue.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
Modified Medical Research Council (mMRC)
mMRC is assessing the subjective degree of breathlessness by patients during physical activity. It rates on a scale from 0 to 4, with a higher rate indicating the worst possible shortness of breath.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
36-Item Short Form Health Survey (SF-36)
SF-36 is assessing the subjective survey health status and quality of life. It consists of eight sections, with scores ranging from 0 to 100. Higher scores indicate better health and less disability.
Measured: Change from baseline (0 week) to follow-up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start2 Mar 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study population will be randomized and separated in two groups, experimental and control group.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ling Tsai, National Cheng Kung University
- Investigators
- Kun-Ling Tsai, Ph.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389734
- Sponsor's protocol ID
- B-ER-111-470
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combining Manual Soft Tissue Release and Physical Exercise Training on Lung Function(LF), Exercise Capacity(EC), and Cardiac Autonomic Function(CAF) in Moderate to Severe COPD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06389734
- Acronym / sponsor ID
- B-ER-111-470
- Conditions
- Chronic Obstructive Pulmonary Disease, Manual Soft Tissue Release, Exercise Training, Lung Function, Exercise Capacity, Cardiac Autonomic Function
- Keywords
- chronic obstructive pulmonary disease, manual soft tissue release, exercise training, lung function, exercise capacity, cardiac autonomic function, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 29 Apr 2024 (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 potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated.
Detailed description
Chronic obstructive pulmonary disease (COPD) commonly presents with accessory respiratory muscle tightness and weakness, affecting chest wall compliance and lung elasticity. However, traditional physical therapy interventions, including pursed-lip breathing, sputum clearance techniques, and respiratory muscle training, are often used in treatment guidelines, with few studies focusing on muscle release for the accessory respiratory muscles. Although the effects of manual therapy on lung function and chest tightness in COPD have been demonstrated, the effects of soft tissue release combined with exercise intervention on COPD, including lung function, exercise capacity, and cardiac autonomic function, remain unknown. Therefore, this study proposes a randomized controlled trial to investigate the effects of manual soft tissue release combined with exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with COPD. It is expected that the results of this study will demonstrate that combining manual soft tissue release with exercise training may increase gas exchange in the lungs, reduce respiratory effort, improve co-morbidities, delay disease progression, and enhance patient quality of life and clinical intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population will be randomized and separated in two groups, experimental and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Manual soft tissue release, Behavioral: Exercise trainingThe intervention group will receive combining manual soft tissue release and exercise training. |
| Control group | Active comparator | Behavioral: Myofascial release, Behavioral: Exercise trainingThe control group will receive combining myofascial release and exercise training. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- GOLD grade II~IV
- Stable condition
- No acute exacerbations in 6 weeks
Key exclusion criteria (7 listed)
- Acute heart failure and, or arrhythmia
- Pulmonary arterial hypertension
- Skeletal and, or neuromuscular disorders
- Chest surgery
- Untreated or uncontrolled conditions
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 |
|---|---|---|
| Manual soft tissue releaseThe manual soft tissue release includes muscle energy techniques and passive stretching, targeting the anterior scalene, upper trapezius, pectoralis major, pectoralis minor, and diaphragm. Three times a week for six weeks, with three rounds per session, each session having three repetitions, with a 30-second break in between, lasting 15 to 30 seconds each time. | Behavioural | Intervention group |
| Myofascial releaseThe myofascial release includes suboccipital muscle, anterior chest wall myofascial, and anterior neck myofascial. Three times a week for six weeks, with three rounds per session, each session having three repetitions, with a 30-second break in between, lasting 15 to 30 seconds each time. | Behavioural | Control group |
| Exercise trainingThe exercise training includes aerobic exercise training by treadmill. The initial intensity is set at 60% to 85% of the average speed measured during the patient's six-minute walk test (6MWT). Intensity adjustments will be made using the Modified Borg Scale (scores ranging from 4 to 7). Training duration is 30 minutes, three times a week for six weeks. | Behavioural | Control group, Intervention group |
Primary outcome
Forced expiratory volume in 1 s (FEV1)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
FEV1 is measured by the lung function test, and the unit presented will be in percent and liter.
forced vital capacity (FVC)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
FVC is measured by the lung function test, and the unit presented will be in percent and liter.
FEV1/FVC ratio
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
FEV1/FVC ratio is measured by the lung function test, and the unit presented will be in percent.
expiratory reserve volume (ERV)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
ERV is measured by the lung function test, and the unit presented will be in liter.
functional residual capacity (FRC)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
FRC is measured by the lung functions test, and the unit presented will be in liters.
inspiratory capacity (IC)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
IC is measured by the lung functions test, and the unit presented will be in liters.
inspiratory reserve volume (IRV),
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
IRV is measured by the lung functions test, and the unit presented will be in liters.
residual volume (RV)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
RV is measured by the lung function test, and the unit presented will be in liters.
total lung capacity (TLC)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
TLC is measured by the lung function test, and the unit presented will be in liters.
tidal volume (TV)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
TV is measured by the lung function test, and the unit presented will be in liters.
vital capacity (VC)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
VC is measured by the lung function test, and the unit presented will be in liters.
14 secondary outcomes
Rate of perceived exertion (RPE)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
Oxygen consumption (VO2)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
oxygen saturation
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
heart rate (HR)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
blood pressure (BP)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
Diaphragmatic mobility
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
Cardiac Autonomic Function
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
six minute walk test (6-MWT)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
maximal expiratory pressure (MEP)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
maximal inspiratory pressure (MIP)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
fatigue severity scale (FSS)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
Modified Medical Research Council (mMRC)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
36-Item Short Form Health Survey (SF-36)
Time frame: Change from baseline (0 week) to follow-up (12 weeks)
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 29 Apr 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.
Kun-Ling Tsai, Ph.D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual soft tissue release, Myofascial release and Exercise training in people with Chronic Obstructive Pulmonary Disease and Manual Soft Tissue Release, run by National Cheng Kung University at 1 site in Taiwan.
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 3 inclusion and 7 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 29 Apr 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 Taiwan. 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?
Forced expiratory volume in 1 s (FEV1) (time frame: Change from baseline (0 week) to follow-up (12 weeks)). The study lists 11 primary outcomes in all. 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 29 Apr 2024.