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Additional Manual Therapy Over Inspiratory Muscle Training in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease Severe, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual therapy technics
Inspiratory Muscle Training
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease Severe focused on measuring copd, manual therapy, inspiratory muscle therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • İstinye University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy additional over Inspiratory muscle training

Inspiratory Muscle Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
July 2, 2021
Sponsor
Istinye University
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1. Study Identification

Unique Protocol Identification Number
NCT04533516
Brief Title
Additional Manual Therapy Over Inspiratory Muscle Training in COPD
Official Title
Effectiveness of 12-Weeks Inspiratory Muscle Training With Manual Therapy in Patients With COPD: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 29, 2020 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istinye University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Severe, Muscle Weakness
Keywords
copd, manual therapy, inspiratory muscle therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy additional over Inspiratory muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Inspiratory Muscle Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy technics
Intervention Description
Manual therapy technics
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Inspiratory Muscle Training
Primary Outcome Measure Information:
Title
Pulmonary Function Test
Description
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.
Time Frame
12 weeks
Title
respiratory muscle strength
Description
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.
Time Frame
12 weeks
Title
6 minute walk test
Description
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.
Time Frame
12 weeks
Title
Dyspnea perception
Description
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).
Time Frame
12 weeks
Title
Fatigue perception
Description
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.
Time Frame
12 weeks
Title
St.George Respiratory Questionnaire
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
İstinye University
City
İstanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Additional Manual Therapy Over Inspiratory Muscle Training in COPD

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