Clinical trial NCT06389734: Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population will be randomized and separated in two groups, experimental and control group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced expiratory volume in 1 s (FEV1)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: forced vital capacity (FVC)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: FEV1/FVC ratio
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: expiratory reserve volume (ERV)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: functional residual capacity (FRC)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: inspiratory capacity (IC)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: inspiratory reserve volume (IRV),
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: residual volume (RV)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: total lung capacity (TLC)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: tidal volume (TV)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: vital capacity (VC)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
Secondary outcomes:
measure: Rate of perceived exertion (RPE)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: oxygen saturation
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: heart rate (HR)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: blood pressure (BP)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: Diaphragmatic mobility
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: Cardiac Autonomic Function
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: six minute walk test (6-MWT)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: maximal expiratory pressure (MEP)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: maximal inspiratory pressure (MIP)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: fatigue severity scale (FSS)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: Modified Medical Research Council (mMRC)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Change from baseline (0 week) to follow-up (12 weeks)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: Study Principal Investigator
name: Kun-Ling Tsai, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: