Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06389734
• Other study ID #: B-ER-111-470
• Status: Completed
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: April 2024
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• GOLD grade II~IV

• Stable condition

• No acute exacerbations in 6 weeks

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Exercise Capacity
• Exercise Training
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Function
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Manual soft tissue release
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 release
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 training
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	forced vital capacity (FVC)	FVC is measured by the lung function test, and the unit presented will be in percent and liter.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	FEV1/FVC ratio	FEV1/FVC ratio is measured by the lung function test, and the unit presented will be in percent.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	expiratory reserve volume (ERV)	ERV is measured by the lung function test, and the unit presented will be in liter.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	functional residual capacity (FRC)	FRC is measured by the lung functions test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	inspiratory capacity (IC)	IC is measured by the lung functions test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	inspiratory reserve volume (IRV),	IRV is measured by the lung functions test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	residual volume (RV)	RV is measured by the lung function test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	total lung capacity (TLC)	TLC is measured by the lung function test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	tidal volume (TV)	TV is measured by the lung function test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Primary	vital capacity (VC)	VC is measured by the lung function test, and the unit presented will be in liters.	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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).	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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).	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	oxygen saturation	oxygen saturation is measured by the oximeter, and the unit presented will be in percent	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	heart rate (HR)	HR is measured by cardiopulmonary exercise test, and the unit presented will be in beat per minute (BPM)	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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).	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	Diaphragmatic mobility	Diaphragmatic mobility is measured by the ultrasound, and the unit presented will be in millimeters	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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)	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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.	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	maximal expiratory pressure (MEP)	MEP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O).	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	maximal inspiratory pressure (MIP)	MIP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O).	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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.	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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.	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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.	Change from baseline (0 week) to follow-up (12 weeks)
Secondary	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.	Change from baseline (0 week) to follow-up (12 weeks)