Additional Manual Therapy Over Inspiratory Muscle Training in COPD

NCT ID: NCT04533516

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-29
• Study Completion Date: 2021-04-12

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease Severe; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Manual therapy technics

Intervention Type: OTHER

Manual therapy technics

Inspiratory Muscle Training

Intervention Type: OTHER

Inspiratory Muscle Training

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.

Group Type: ACTIVE_COMPARATOR

Inspiratory Muscle Training

Intervention Type: OTHER

Inspiratory Muscle Training

Interventions

Manual therapy technics

Manual therapy technics

Intervention Type: OTHER

Inspiratory Muscle Training

Inspiratory Muscle Training

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Çırak

Physiotherapist, PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstinye University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Manual therapy in COPD

Identifier Type: -

Identifier Source: org_study_id