Additional Manual Therapy Over Inspiratory Muscle Training in COPD

Effectiveness of 12-Weeks Inspiratory Muscle Training With Manual Therapy in Patients With COPD: Randomized Controlled Study

The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new approach that has not yet been investigated in COPD.

Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD patients.

Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Chronic Obstructive Pulmonary Disease Severe
• Intervention / Treatment: Other: Manual therapy technics; Other: Inspiratory Muscle Training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34010
    • Istinye University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of chronic obstructive pulmonary disease
• Being clinically stable
• Having FEV1/FVC ratio of ≤ 50% of the predicted value after bronchodilator drugs.

Exclusion Criteria:

• Having an acute bronchitis,
• Having a pneumonia,
• Having an exacerbation of COPD,
• Having thoracic spinal scoliosis,
• Having substantial chest wall deformity, or acute rib or vertebral fracture.
• Unable to perform the pulmonary function test because of cognitive or physical impairments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Therapy additional over Inspiratory muscle training; Participants receive manual therapy protocol session three times a week for 12 weeks. The manual therapy protocol session lasts 30 minutes and included of the following manual therapy techniques: suboccipital decompression, gliding of the cervical vertebral articulations in the anterior/posterior direction, myofascial release of sternocleidomastoid and trapezius muscles, gliding of sternoclavicular joint in the anterior/posterior direction, myofascial release of intercostal muscles and paravertebral muscles, diaphragmatic release, rib raising, mobilization of scapulothoracic joint, and gliding of the thoracic vertebral articulations in the anterior/posterior direction. And all participants receive inspiratory muscle training.	Other: Manual therapy technics; Manual therapy technics; Other: Inspiratory Muscle Training; Inspiratory Muscle Training
Active Comparator: Inspiratory Muscle Training; Participants receive only inspiratory muscle training by using Threshold Inspiratory Muscle Training device. Training load is 40% of the measured maximum inspiratory pressure, weekly. Participants receive inspiratory muscle training session for 30 min-per day, 7 days per week, for 12 weeks.	Other: Inspiratory Muscle Training; Inspiratory Muscle Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function Test	Before the pulmonary function test, all subjects rested to avoid fatigue. The lung function test including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and vital capacity (VC) was performed in a seated position using a portable spirometer according to the American Thoracic Society guidelines.	12 weeks
respiratory muscle strength	For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity.	12 weeks
6 minute walk test	6 minute walk test (6MWT) was applied to measure exercise capacity. The patient's heart rate, breathing frequency, and oxygen saturation were monitored with the pulse oximeter, and the values were recorded before and after the test. The distance was expressed both as metres.	12 weeks
Dyspnea perception	Dyspnea perception was assessed using the modified Medical Research Council (MMRC) dyspnea scale, Levels of dyspnea are graded 0 (absence of dyspnea during strenuous exercise), to 4 (dyspnea during daily activities).	12 weeks
Fatigue perception	Fatigue perception was assessed with Turkish version of Fatigue Severity Scale. A high score indicates increased fatigue intensity and the maximum score of the scale is 63.	12 weeks
St.George Respiratory Questionnaire	Quality of life was measured using the Turkish version of St.George Respiratory Questionnaire (SGRQ). It is a specific quality of life questionnaire for respiratory diseases. SGRQ consists of three subscale and 50 items; symptoms (8 items), activities (16 items), effects of the disease (26 items). Each subscale is scored ranging from 0 to 100 points. High scores indicate that worsened the quality of life.	12 weeks

Collaborators and Investigators

• Sponsor: Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2020
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: manual therapy; copd; inspiratory muscle therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Muscle Weakness
• Other Study ID Numbers: manual therapy in COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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