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

NCT ID: NCT06389734

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2024-02-02

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Manual soft tissue release

Intervention Type: 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.

Exercise training

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Myofascial release

Intervention Type: 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.

Exercise training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

Kun-Ling Tsai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kun-Ling Tsai, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

B-ER-111-470

Identifier Type: -

Identifier Source: org_study_id