- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04193683
The Effect Of Myofascial Release Technique On Respiratory Parameters in Subjects With Short Hamstring Muscle
The Effect Of Myofascial Release Technique On Respiratory Functions, Respiratory Muscle Strength and Endurance in Subjects With Short Hamstring Muscle
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hamstring flexibility is important to maintain activities such as walking and running in daily life. Hamstring muscle shortness, commonly seen in the community, is a risk factor for many musculoskeletal pathologies. Clinical observations have shown that the shortness of the Hamstring muscle causes spinal malalignment. This deterioration of the spine alignment may adversely affect the rib cage expansion. Moreover, considering that the optimal length of the muscles provides optimal contraction, it was found that the spinal malalignment adversely affected the effective contraction of the diaphragm by changing the position of diaphragm. A different view is that, because the fascia functions as a single tissue surrounding the entire body, a restriction in the hamstring muscle can also cause a restriction in distal muscles such as diaphragm through the fascia.
There are many treatment methods used to increase the flexibility of the hamstring muscle. One of these methods is the myofascial release technique. In this technique, which targets both muscle and fascia, applying light and prolonged pressure provides the myo-fascial complex to reach its optimal length, resulting in the optimal function of the muscle. In our best knowledge, no study has evaluated the effect of myofascial release technique on respiratory parameters in patients with hamstring muscle shortness.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Bezmialem Vakıf University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- more than 15 degrees knee flexion angle during popliteal angle test,
- no generalized joint laxity according to Beighton Criteria, and
- no musculoskeletal problems of lower extremities.
Exclusion Criteria:
- history of lower extremity and/or axial skeletal fracture;
- recent muscle, tendon injury in lower extremity;
- history of lumbal disc herniation, arthritic and/or inflammatory disease;
- obesity, diabetes and/or metabolic syndrome;
- history of surgery in the last month,
- using muscle relaxant medication in the last month;
- received manual therapy in the last month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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SHAM_COMPARATOR: Sham-Ultrasound
Intervention will include one session sham-ultrasound application to both lower extremities of participant.
The total time will be 15 minutes.
|
Sham-ultrasound will be applied to back of legs and thighs in both extremities without pressure and all parameters of the ultrasound device except the timer will be closed.
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EXPERIMENTAL: Myofascial Release Technique+Sham-Ultrasound
In addition to one session sham-ultrasound, the intervention will include one session myofascial release technique to both lower extremities of participant.
The total time will be 30 minutes.
|
Sham-ultrasound will be applied to back of legs and thighs in both extremities without pressure and all parameters of the ultrasound device except the timer will be closed.
Myofascial release technique will bi applied bottom of the feet, back of the legs and hamstrings in both extremities.
The practitioner will decide how long she should stay in a region according to the feeling of releasing in the tissue.
The technique will be applied to a region at least 3 times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline Forced Vital Capacity (FVC) at 60 minutes
Time Frame: 60 minutes
|
Respiratory Function Test
|
60 minutes
|
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Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 60 minutes
Time Frame: 60 minutes
|
Respiratory Function Test
|
60 minutes
|
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Change from baseline FEV1/FVC at 60 minutes
Time Frame: 60 minutes
|
Respiratory Function Test
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60 minutes
|
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Change from baseline Peak Expiratory Flow (PEF) at 60 minutes
Time Frame: 60 minutes
|
Respiratory Function Test
|
60 minutes
|
|
Change from baseline Forced expiratory flow over the middle one half of the FVC (FEF25-75%) at 60 minutes
Time Frame: 60 minutes
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Respiratory Function Test
|
60 minutes
|
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Change from baseline maximum inspiratory pressure (MIP) at 60 minutes
Time Frame: 60 minutes
|
Respiratory Muscle Strength Test
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60 minutes
|
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Change from baseline maximum expiratory pressure (MEP) at 60 minutes
Time Frame: 60 minutes
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Respiratory Muscle Strength Test
|
60 minutes
|
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Change from baseline constant inspiratory threshold load test at 60 minutes
Time Frame: 60 minutes
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Respiratory Muscle Endurance Test
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline axillary region chest circumference measurement during inspiration at 60 minutes
Time Frame: 60 minutes
|
Chest Circumference Measurement
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60 minutes
|
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Change from baseline axillary region chest circumference measurement during expiration at 60 minutes
Time Frame: 60 minutes
|
Chest Circumference Measurement
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60 minutes
|
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Change from baseline xiphoid region chest circumference measurement during inspiration at 60 minutes
Time Frame: 60 minutes
|
Chest Circumference Measurement
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60 minutes
|
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Change from baseline xiphoid region chest circumference measurement during expiration at 60 minutes
Time Frame: 60 minutes
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Chest Circumference Measurement
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60 minutes
|
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Change from baseline subcostal region chest circumference measurement during inspiration at 60 minutes
Time Frame: 60 minutes
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Chest Circumference Measurement
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60 minutes
|
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Change from baseline subcostal region chest circumference measurement during expiration at 60 minutes
Time Frame: 60 minutes
|
Chest Circumference Measurement
|
60 minutes
|
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Change from baseline axillary region chest expansion test at 60 minutes
Time Frame: 60 minutes
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Chest Circumference Measurement
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60 minutes
|
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Change from baseline xiphoid region chest expansion test at 60 minutes
Time Frame: 60 minutes
|
Chest Circumference Measurement
|
60 minutes
|
|
Change from baseline subcostal region chest expansion test at 60 minutes
Time Frame: 60 minutes
|
Chest Circumference Measurement
|
60 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Betül Çınar, Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bvubcinar01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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