- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893445
The Effect of Deep Tissue Massage on Respiratory Parameters in People with Asthma
Bronchial asthma, as a chronic inflammatory disease of the respiratory tract, significantly reduces the quality of life of patients. Standard treatment includes pharmacotherapy, but a holistic approach, including manual therapies, can support pharmacological therapy, reducing the need for drugs.
The aim of the research is to verify whether deep tissue massage (DTM) techniques applied to the chest significantly affect respiratory parameters in people with asthma. The study is the next stage of the study conducted on healthy people. After obtaining positive results in the study involving people not suffering from respiratory diseases, the next step is to examine people with, in this case, bronchial asthma. It is important to determine whether the use of this form of manual therapy can bring benefits in the context of improving respiratory functions, reducing respiratory muscle tension and relieving subjective symptoms associated with asthma, such as shortness of breath or limitations in everyday functioning.
The hypothesis assumes that DTM techniques can have a bigger effect on the respiratory system than classic massage (CM).
The study is a randomized controlled trial, where participants will be randomly assigned to one of two groups: the study group (subjected to DTM) or the control group (subjected to CM). Before and after the massage intervention, participants will undergo spirometry to assess the changes in respiratory parameters. The obtained data will then be analyzed for effects on respiratory parameters and differences between both groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bartosz T Trybulec, PhD
- Phone Number: +48 12 422 56 83
- Email: bartosz.trybulec@uj.edu.pl
Study Contact Backup
- Name: Sarah Duk, MSc
- Email: sarah.duk@doctoral.uj.edu.pl
Study Locations
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Cracow, Poland
- Department of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College
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Contact:
- Sarah Duk, MSc
- Email: sarah.duk@doctoral.uj.edu.pl
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Contact:
- Bartosz Trybulec, PhD
- Phone Number: +48 12 422 56 83
- Email: bartosz.trybulec@uj.edu.pl
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Contact:
- Bartosz Trybulec, PhD
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Contact:
- Sarah Duk, MSc
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Wieliczka, Poland
- The "Wieliczka" Salt Mine Health Resort
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Contact:
- Sarah Duk, MSc
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Contact:
- Marek Koprowski, PhD
- Phone Number: +48 12 278 73 83
- Email: marek.koprowski@kopalnia.pl
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Contact:
- Marek Koprowski, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosed with bronchial asthma
- stable health condition, allowing participation in the study
- informed consent to participate in the study
Exclusion Criteria:
- acute or chronic comorbidities that may affect the results (e.g. COPD, heart failure, cancer)
- any chest surgery performed within the last 6 months
- contraindications to massage (e.g. skin infections, wounds)
- pregnancy
- participation in other clinical trials in the last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Deep Tissue Massage Group
The one session of deep tissue massage will be performed.
The patient's positions will be changed depending on the specificity of used techniques.
The following techniques will be used: • Shifting the rectus abdominis m., • Stretching of the fascia within the costal arches, • trigger points compression (30-60 s).
• Stretching of the chest fascia, superficially with forearm or fingertips on intercostal muscles, • "filleting" the pectoral muscles, • "hook and stretch" with the proximal phalanges of the fingers 2-4 and the forearm • "filleting" between the pectoral muscles and the deltoids, • Releasing the lateral edge of the scapula using the fingers and stretching the tissues, Releasing the medial edge of the scapula using the fingers and the weight of the patient, • "hook and stretch" of the trapezius muscle, • Subsequently, the patient will take a prone position.
• Stretching of the levator scapulae and supraspinatus muscles using the fist, forearm and elbow will be performed.
|
Administered as a soft tissue mobilization performed by the therapist with fingertips, knuckles, elbows and/or fists on the tissues that manifest symptoms of fascial restrictions.
The techniques were performed with individually adjusted force until the change (eg.
increased mobility) in the tissue being treated was stated by the therapist.
|
|
Active Comparator: Classic Massage Group
The one session of classic massage will be performed.
The massage will be performed with moderate force.
The entire procedure will take about 15-20 min.
The sequence of standard classic massage techniques will be used in standard way and patterns.
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The subject was lying supine on the table, with a roller placed under the knee joints, the upper limbs along the body.
The following sequence of techniques was used in the longitudinal and transverse strands and in the intercostal spaces (excluding the breast in women): effleurage, friction, petrissage, pressures, tapotement and vibrations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of change of lung vital capacity
Time Frame: twice: before and immediately after procedure administration in both groups
|
The vital capacity of the lungs will be assessed with spirometer.
The subject stood with legs hip-width apart.
For each measurement, disposable cardboard mouthpieces will be used.
The examined person holds the device vertically with both hands.
At the examiner's command, subject will take in as much air as possible, then tightly biet the mouthpiece with his mouth, and with all of their strength, exhale air into the device for as long as possible.
The subject will have only 1 attempt-measured values were recorded with an accuracy of 50 mL.
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twice: before and immediately after procedure administration in both groups
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Assessment of change of chest circumference
Time Frame: twice: before and immediately after procedure administration in both groups
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The chest circumference will be measured with a measuring tape, wrapped horizontally around the chest at the level of the xiphoid process.
The subject stand with feet hip-width apart, arms hanging along the body.
At the command, the subject will take a maximum breathe in (first measurement) and exhale to the maximum for the next (second measurement).
Obtained values will be recorded with an accuracy of 0.5 cm.
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twice: before and immediately after procedure administration in both groups
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Assessment of change of blood oxygen saturation
Time Frame: twice: before and immediately after procedure administration in both groups
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Testing blood oxygen saturation will be performed in a sitting position with digital pulseoximeter.
The device will be put on the second finger of the left hand each time.
The highest value displayed by the pulseoximeter within 30 s will be recorded with an accuracy of 1%.
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twice: before and immediately after procedure administration in both groups
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Asessment of change of Peak Expiratory Flow (PEF)
Time Frame: twice: before and immediately after procedure administration in both groups
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Dynamic spirometry test will be performed with spirometer to assess the peak expiratory flow (PEF) measured in liters per second [l/s].
The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly.
On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".
This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.
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twice: before and immediately after procedure administration in both groups
|
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Assessment of change of Forced Vital Capacity
Time Frame: twice: before and immediately after procedure administration in both groups
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The forced vital capacity (FVC), measured in liters will be assessed with spirometer.
The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly.
On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".
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twice: before and immediately after procedure administration in both groups
|
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Assessment of change of Maximum Expiratory Flow
Time Frame: twice: before and immediately after procedure administration in both groups
|
Assessment of the maximum expiratory flow (MEF), measured in liters per second will be performed with spirometer.
The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly.
On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".
This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.
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twice: before and immediately after procedure administration in both groups
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Assessment of change of Forced Expiratory Volume in one second
Time Frame: twice: before and immediately after procedure administration in both groups
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Assessment of the forced expiratory volume in 1 s (FEV1) measured in literswill be performed with spirometer.
The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly.
On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".
This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.
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twice: before and immediately after procedure administration in both groups
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Assessment of change of Maximum Voluntary Ventilation
Time Frame: twice: before and immediately after procedure administration in both groups
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Assessing the maximum voluntary ventilation (MVV) measured in liters per minute will be performed with spirometer.
The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly.
On my command, inhale and exhale as quickly and as deeply as possible for 15 s until you hear the 'stop' command.
This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.
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twice: before and immediately after procedure administration in both groups
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bartosz T Trybulec, PhD, Jagiellonian University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 118.0043.1.81.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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