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

NCT06389734 | Completed

• 1 other identifier: B-ER-111-470
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (14)

• Rate of perceived exertion (RPE)

  Change from baseline (0 week) to follow-up (12 weeks)

• Oxygen consumption (VO2)

  Change from baseline (0 week) to follow-up (12 weeks)

• oxygen saturation

  Change from baseline (0 week) to follow-up (12 weeks)

• heart rate (HR)

  Change from baseline (0 week) to follow-up (12 weeks)

• blood pressure (BP)

  Change from baseline (0 week) to follow-up (12 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive combining manual soft tissue release and exercise training.

Behavioral: Manual soft tissue release; Behavioral: Exercise training

Control group

ACTIVE COMPARATOR

The control group will receive combining myofascial release and exercise training.

Behavioral: Myofascial release; Behavioral: Exercise training

Interventions

Manual soft tissue release BEHAVIORAL

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.

Intervention group

Myofascial release BEHAVIORAL

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.

Control group

Exercise training BEHAVIORAL

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.

Control group; Intervention group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GOLD grade II\~IV
• Stable condition
• No acute exacerbations in 6 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Myofascial Release Therapy; Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kun-Ling Tsai, Ph.D.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study population will be randomized and separated in two groups, experimental and control group.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 29, 2024
• Study Start: March 2, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)