Back to resultsThe Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD, Pulmonary Function, Soft Tissue Mobilization
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
IASTM+respiratory Exercise
Respiratory Exercise
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with GOLD stage I-II COPD
- Between the ages of 40-65
- COPD in stable period
- No other respiratory disease that impairs respiratory functions such as asthma
- Knee flexion angle of 15 degrees and above in the hamstring muscle shortness test,
- Individuals without musculoskeletal problems in their lower extremities were included.
Exclusion Criteria:
- COPD patients who receive home oxygen therapy or who need oxygen therapy frequently
- COPD exacerbation, hospitalization with acute exacerbation in the last 15 days
- Pregnancy
- Kyphoscoliosis, advanced postural disorder
- Prior thoracic surgery
- Advanced heart failure
- Patients with primary pulmonary hypertension or have had a pulmonary embolism,
- Having serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
- Neuromuscular disease
- Having dementia, Alzheimer's or advanced cognitive problems,
- Diagnosed with lung cancer or other malignancy,
- People with morbid obesity will not be included in the study.
Sites / Locations
- Emine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IASTM group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Respiratory Function
Respiratory Function evaluated with spirometer
Secondary Outcome Measures
Chest circumference measurement
It will be performed in a standing position with body weight evenly distributed over both lower extremities. During the tidal volume maximum inspiration and maximum expiration, the body of the person will be surrounded by a tape measure separately from the fourth intercostal space (axillary region), xiphoid process and subcostal region lines. To determine rib cage mobility, the difference between chest circumference measurements at maximum inspiration and maximum expiration will be recorded in centimeters. Measurements will be repeated for both groups before and after the application.
Popliteal angle test
Popliteal Angle Test will be used to evaluate hamstring muscle mobility. The person to be evaluated will be placed on the back with the hip and knee joints flexed to 90° and the contralateral side with the extremity extended. The person will be instructed to hold the back surface of the leg with their hands and maintain the flexion angle. Meanwhile, the inclinometer will be detected in the anterior-midline of the tibia. Then, the person will be asked to extend the knee as much as tolerated and the last degree of movement will be measured. It will be repeated before and after the application for both the treatment and control groups.
Finger-floor distance measurement
To consider the mobility of the posterior chain muscles as a whole, the finger-to-ground distance test with high reliability and sensitivity will be used. The person standing on a block with a height of 15 cm from the ground will be asked to bend forward and touch his toes without bending his knees, and at the end of the movement, the distance between the distal end of his extended fingers and the ground will be measured. Values above the block will be evaluated as minus, and values below the block will be evaluated as plus. The measurement will be repeated three times and the average value will be recorded. It will be repeated before and after the application for both the treatment and control groups.
Hand grip strength
Measurement will be taken with the patients in a sitting position, shoulder adduction, elbow flexion at 90°, forearm prono-supination neutral, and wrist joint in neutral position. 3 consecutive measurements will be provided with 60-second rest breaks between measurements and the result obtained from the average of the three measurements will be recorded. It will be repeated before and after the application for both the treatment and control groups.
6-minute walk test
The 6-minute walk test (6MWT) is the most commonly used field test in patients with COPD. Participants will be asked to walk the longest distance they can walk at their own pace for a period of 6 minutes, under the supervision of a physiotherapist, in a 30-meter straight corridor. After the test is complete, the total distance walked will be recorded in meters. It will be repeated before and after the application for both the treatment and control groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05023876
Brief Title
The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
Official Title
Effect of Instrument Assisted Soft Tissue Mobilization in Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization applied to the hamstring muscle on respiratory function in patients with COPDThe patients to be included in the study will be divided into two groups by simple randomization. A group will be given breathing exercises (pursed lip breathing, diaphragmatic breathing and thoracic expansion exercises) as a home program. The other group will be given breathing exercises in the form of a home program in addition to 1 session of EDYM per week. Both groups will be evaluated before and 4 weeks after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pulmonary Function, Soft Tissue Mobilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IASTM group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
IASTM+respiratory Exercise
Intervention Description
Instrument assisted soft tissue mobilization
Intervention Type
Other
Intervention Name(s)
Respiratory Exercise
Intervention Description
Respiratory Exercise
Primary Outcome Measure Information:
Title
Respiratory Function
Description
Respiratory Function evaluated with spirometer
Time Frame
5 minute
Secondary Outcome Measure Information:
Title
Chest circumference measurement
Description
It will be performed in a standing position with body weight evenly distributed over both lower extremities. During the tidal volume maximum inspiration and maximum expiration, the body of the person will be surrounded by a tape measure separately from the fourth intercostal space (axillary region), xiphoid process and subcostal region lines. To determine rib cage mobility, the difference between chest circumference measurements at maximum inspiration and maximum expiration will be recorded in centimeters. Measurements will be repeated for both groups before and after the application.
Time Frame
5 minute
Title
Popliteal angle test
Description
Popliteal Angle Test will be used to evaluate hamstring muscle mobility. The person to be evaluated will be placed on the back with the hip and knee joints flexed to 90° and the contralateral side with the extremity extended. The person will be instructed to hold the back surface of the leg with their hands and maintain the flexion angle. Meanwhile, the inclinometer will be detected in the anterior-midline of the tibia. Then, the person will be asked to extend the knee as much as tolerated and the last degree of movement will be measured. It will be repeated before and after the application for both the treatment and control groups.
Time Frame
3 minutes
Title
Finger-floor distance measurement
Description
To consider the mobility of the posterior chain muscles as a whole, the finger-to-ground distance test with high reliability and sensitivity will be used. The person standing on a block with a height of 15 cm from the ground will be asked to bend forward and touch his toes without bending his knees, and at the end of the movement, the distance between the distal end of his extended fingers and the ground will be measured. Values above the block will be evaluated as minus, and values below the block will be evaluated as plus. The measurement will be repeated three times and the average value will be recorded. It will be repeated before and after the application for both the treatment and control groups.
Time Frame
3 minutes
Title
Hand grip strength
Description
Measurement will be taken with the patients in a sitting position, shoulder adduction, elbow flexion at 90°, forearm prono-supination neutral, and wrist joint in neutral position. 3 consecutive measurements will be provided with 60-second rest breaks between measurements and the result obtained from the average of the three measurements will be recorded. It will be repeated before and after the application for both the treatment and control groups.
Time Frame
3 minutes
Title
6-minute walk test
Description
The 6-minute walk test (6MWT) is the most commonly used field test in patients with COPD. Participants will be asked to walk the longest distance they can walk at their own pace for a period of 6 minutes, under the supervision of a physiotherapist, in a 30-meter straight corridor. After the test is complete, the total distance walked will be recorded in meters. It will be repeated before and after the application for both the treatment and control groups.
Time Frame
6 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with GOLD stage I-II COPD
Between the ages of 40-65
COPD in stable period
No other respiratory disease that impairs respiratory functions such as asthma
Knee flexion angle of 15 degrees and above in the hamstring muscle shortness test,
Individuals without musculoskeletal problems in their lower extremities were included.
Exclusion Criteria:
COPD patients who receive home oxygen therapy or who need oxygen therapy frequently
COPD exacerbation, hospitalization with acute exacerbation in the last 15 days
Pregnancy
Kyphoscoliosis, advanced postural disorder
Prior thoracic surgery
Advanced heart failure
Patients with primary pulmonary hypertension or have had a pulmonary embolism,
Having serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
Neuromuscular disease
Having dementia, Alzheimer's or advanced cognitive problems,
Diagnosed with lung cancer or other malignancy,
People with morbid obesity will not be included in the study.
Facility Information:
Facility Name
Emine
City
İstanbul
ZIP/Postal Code
34959
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs