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Completed

NCT Number: NCT06389734

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiac Autonomic Function Chronic Disease Disease Attributes Exercise Capacity Exercise Training Lung Diseases Lung Diseases, Obstructive Lung Function Manual Soft Tissue Release Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 701, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Forced expiratory volume in 1 s (FEV1)

    Time frame: 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.

  2. forced vital capacity (FVC)

    Time frame: 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.

  3. FEV1/FVC ratio

    Time frame: 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.

  4. expiratory reserve volume (ERV)

    Time frame: 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.

  5. functional residual capacity (FRC)

    Time frame: 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.

  6. inspiratory capacity (IC)

    Time frame: 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.

  7. inspiratory reserve volume (IRV),

    Time frame: 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.

  8. residual volume (RV)

    Time frame: 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.

  9. total lung capacity (TLC)

    Time frame: 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.

  10. tidal volume (TV)

    Time frame: 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.

  11. vital capacity (VC)

    Time frame: 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 outcomes

  1. Rate of perceived exertion (RPE)

    Time frame: 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).

  2. Oxygen consumption (VO2)

    Time frame: 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).

  3. oxygen saturation

    Time frame: 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

  4. heart rate (HR)

    Time frame: 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)

  5. blood pressure (BP)

    Time frame: 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).

  6. Diaphragmatic mobility

    Time frame: 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

  7. Cardiac Autonomic Function

    Time frame: 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)

  8. six minute walk test (6-MWT)

    Time frame: 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.

  9. maximal expiratory pressure (MEP)

    Time frame: 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).

  10. maximal inspiratory pressure (MIP)

    Time frame: 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).

  11. St. George's Respiratory Questionnaire (SGRQ)

    Time frame: 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.

  12. fatigue severity scale (FSS)

    Time frame: 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.

  13. Modified Medical Research Council (mMRC)

    Time frame: 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.

  14. 36-Item Short Form Health Survey (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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