COPDNCT05023876
The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
A study testing IASTM+respiratory Exercise and Respiratory Exercise in people with COPD and Pulmonary Function, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- COPD, Pulmonary Function, Soft Tissue Mobilization
- What is being tested?
- IASTM+respiratory Exercise and Respiratory Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2022to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COPD, Pulmonary Function, Soft Tissue Mobilization
- Being tested
- IASTM+respiratory Exercise, Respiratory Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTM+respiratory ExerciseOther
Instrument assisted soft tissue mobilization
Respiratory ExerciseOther
Respiratory Exercise
| Study group | Role | What they receive |
|---|---|---|
| IASTM group | Experimental | Not described Receives: Other: Respiratory Exercise |
| Control Group | Experimental | Not described Receives: Other: IASTM+respiratory Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function
Respiratory Function evaluated with spirometer
Measured: 5 minute
Secondary outcomes (5)
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.
Measured: 5 minute
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.
Measured: 3 minutes
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.
Measured: 3 minutes
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.
Measured: 3 minutes
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.
Measured: 6 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start14 Mar 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023876
- Sponsor's protocol ID
- 006
- Status last verified
- Jul 2024
- First submitted
- 21 Aug 2021
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument Assisted Soft Tissue Mobilization in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05023876
- Acronym / sponsor ID
- 006
- Conditions
- COPD, Pulmonary Function, Soft Tissue Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM group | Experimental | Other: Respiratory Exercise |
| Control Group | Experimental | Other: IASTM+respiratory Exercise |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IASTM+respiratory ExerciseInstrument assisted soft tissue mobilization | Other | Control Group |
| Respiratory ExerciseRespiratory Exercise | Other | IASTM group |
Primary outcome
Respiratory Function
Time frame: 5 minute
Respiratory Function evaluated with spirometer
5 secondary outcomes
Chest circumference measurement
Time frame: 5 minute
Popliteal angle test
Time frame: 3 minutes
Finger-floor distance measurement
Time frame: 3 minutes
Hand grip strength
Time frame: 3 minutes
6-minute walk test
Time frame: 6 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM+respiratory Exercise and Respiratory Exercise in people with COPD and Pulmonary Function, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.