Additional Manual Therapy Over Inspiratory Muscle Training in COPD

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533516
• Other study ID #: Manual therapy in COPD
• Status: Completed
• Phase: N/A
• Start date: August 29, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: July 2021
• Source: Istinye University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 12, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Severe
• Lung Diseases, Obstructive
• Muscle Weakness
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Other:
• Manual therapy technics
Manual therapy technics
• Inspiratory Muscle Training
Inspiratory Muscle Training

Locations

Country	Name	City	State
Turkey	Istinye University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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