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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Exercise Training; Exercise Capacity; Lung Function; Manual Soft Tissue Release; Cardiac Autonomic Function
• Intervention / Treatment: Behavioral: Manual soft tissue release; Behavioral: Exercise training; Behavioral: Myofascial release

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive combining manual soft tissue release and exercise training.	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.; Behavioral: 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.
Active Comparator: Control group; The control group will receive combining myofascial release and exercise training.	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Investigators: Principal Investigator: Kun-Ling Tsai, Ph.D., Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lung function; exercise capacity; pulmonary rehabilitation; exercise training; chronic obstructive pulmonary disease; cardiac autonomic function; manual soft tissue release
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: B-ER-111-470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No