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

Not Applicable

Completed

• Conditions: Manual Soft Tissue Release; Exercise Capacity; Cardiac Autonomic Function; Chronic Obstructive Pulmonary Disease; Exercise Training; Lung Function

• Registration Number: NCT06389734
• Lead Sponsor: National Cheng Kung University

Brief 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.

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 Timeline

• Study Start: 2023-03-02
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 s (FEV1)	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.
FEV1/FVC ratio	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)	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.
residual volume (RV)	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.
inspiratory reserve volume (IRV),	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.
forced vital capacity (FVC)	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.
inspiratory capacity (IC)	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.
tidal volume (TV)	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.
functional residual capacity (FRC)	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.
total lung capacity (TLC)	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.
vital capacity (VC)	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.

Secondary Outcome Measures

Name	Time	Method
six minute walk test (6-MWT)	Change from baseline (0 week) to follow-up (12 weeks)	6-MWT assesses the distance a person can walk within 6 minutes, and the unit presented will be in meters.
fatigue severity scale (FSS)	Change from baseline (0 week) to follow-up (12 weeks)	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.
Rate of perceived exertion (RPE)	Change from baseline (0 week) to follow-up (12 weeks)	RPE is measured by the cardiopulmonary exercise test. This scale ranges from 0 (very light activity) to 10 (maximum effort activity).
Oxygen consumption (VO2)	Change from baseline (0 week) to follow-up (12 weeks)	VO2 is measured by the cardiopulmonary exercise test, and the unit presented will be in milliliters of oxygen consumed per minute (ml/min).
heart rate (HR)	Change from baseline (0 week) to follow-up (12 weeks)	HR is measured by cardiopulmonary exercise test, and the unit presented will be in beat per minute (BPM)
blood pressure (BP)	Change from baseline (0 week) to follow-up (12 weeks)	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).
oxygen saturation	Change from baseline (0 week) to follow-up (12 weeks)	oxygen saturation is measured by the oximeter, and the unit presented will be in percent
Diaphragmatic mobility	Change from baseline (0 week) to follow-up (12 weeks)	Diaphragmatic mobility is measured by the ultrasound, and the unit presented will be in millimeters
Cardiac Autonomic Function	Change from baseline (0 week) to follow-up (12 weeks)	Cardiac Autonomic Function is measured by heart rate variability of electrocardiography, and the unit presented will be in millisecond (ms) and millisecond square (ms2)
Modified Medical Research Council (mMRC)	Change from baseline (0 week) to follow-up (12 weeks)	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.
36-Item Short Form Health Survey (SF-36)	Change from baseline (0 week) to follow-up (12 weeks)	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.
maximal expiratory pressure (MEP)	Change from baseline (0 week) to follow-up (12 weeks)	MEP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O).
maximal inspiratory pressure (MIP)	Change from baseline (0 week) to follow-up (12 weeks)	MIP is measured by the pressure meter, and the unit presented will be in centimetre of water (cmH2O).
St. George's Respiratory Questionnaire (SGRQ)	Change from baseline (0 week) to follow-up (12 weeks)	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.

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan