- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05023876
The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
July 30, 2024 updated by: Emine Atıcı, Okan University
Effect of Instrument Assisted Soft Tissue Mobilization in Chronic Obstructive Pulmonary Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey, 34959
- Emine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
|
Instrument assisted soft tissue mobilization
|
|
Experimental: IASTM group
|
Respiratory Exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Function
Time Frame: 5 minute
|
Respiratory Function evaluated with spirometer
|
5 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest circumference measurement
Time Frame: 5 minute
|
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.
|
5 minute
|
|
Popliteal angle test
Time Frame: 3 minutes
|
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.
|
3 minutes
|
|
Finger-floor distance measurement
Time Frame: 3 minutes
|
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.
|
3 minutes
|
|
Hand grip strength
Time Frame: 3 minutes
|
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.
|
3 minutes
|
|
6-minute walk test
Time Frame: 6 minute
|
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.
|
6 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2022
Primary Completion (Actual)
September 28, 2022
Study Completion (Actual)
September 28, 2022
Study Registration Dates
First Submitted
August 21, 2021
First Submitted That Met QC Criteria
August 21, 2021
First Posted (Actual)
August 27, 2021
Study Record Updates
Last Update Posted (Actual)
August 1, 2024
Last Update Submitted That Met QC Criteria
July 30, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 006
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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