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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05093179
Other study ID # 1072.6120.7.2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date March 31, 2019

Study information

Verified date October 2021
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions, can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis of the DTM effect on respiratory parameters in healthy people. People of both sexes living in the city of Cracow were recruited to the study by the authors personally and through social media. An original questionnaire was completed in the presence of the examiner in order to collect the participants characteristics data. Questions about past diseases, previous surgical procedures or injuries, currently taken medications or the level of physical activity were asked to check the inclusion/exclusion criteria. The study involved a group of 40 people divided into two subgroups. The experimental group underwent a single DTM session. Classic massage was performed in the control group. Before and after treatment the lung vital capacity, chest circumference and oxygen saturation were measured and a spirometry test was performed. The main hypothesis assumed that static respiratory parameters should increase after the treatment session more in the experimental than in control group while the dynamic respiratory parameters would not differ significantly in both groups before and after treatment.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 25 Years
Eligibility Inclusion Criteria: 1. Physical activity of minimum 30 min. duration, at least 3 times a week. 2. No chest injuries. 3. No contraindications for DTM/classic massage. 4. No serious diseases of the respiratory and/or cardiovascular systems. 5. No tobacco products smoking (incl.e-smoking). 6. No posture defects that could affect the chest mobility. Exclusion Criteria: 1. Contraindications to DTM/classic massage of the chest. 2. Occurrence of serious diseases of the respiratory/cardiovascular system now or in the past. 3. Lack of or low physical activity (< 30 min min. 3 times per week). 4. Tobacco smoking (incl.e-smoking). 5. Chest injuries. 6. Posture defects that may affect the chest mobility.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Deep tissue massage
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.
Classic massage
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.

Locations

Country Name City State
Poland Institute of Physiotherapy Jagiellonian University Medical College Kraków

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of change of lung vital capacity The vital capacity of the lungs was assessed with spirotest (Riester, mod. 5260). The subject stood with legs hip-width apart. For each measurement, disposable cardboard mouthpieces were used. The examined person held the device vertically with both hands. At the examiner's command, subject took in as much air as possible, then tightly bit the mouthpiece with his mouth, and with all of their strength, exhaled air into the device for as long as possible. The subject had only 1 attempt-measured values were recorded with an accuracy of 50 mL. twice: before and immediately after procedure administration in both groups
Primary Assessment of change of blood oxygen saturation Testing blood oxygen saturation was performed in a sitting position with digital pulseoximeter CMS50D. The device was put on the second finger of the left hand each time. The highest value displayed by the pulseoximeter within 30 s was recorded with an accuracy of 1%. twice: before and immediately after procedure administration in both groups
Primary Assessment of change of chest circumference The chest circumference was measured with a measuring tape, wrapped horizontally around the chest at the level of the xiphoid process. The subject was standing with feet hip-width apart, arms hanging along the body. At the command, the subject would take a maximum breathe in (first measurement) and exhale to the maximum for the next (second measurement). Obtained values were recorded with an accuracy of 0.5 cm. twice: before and immediately after procedure administration in both groups
Primary Asessment of change of Peak Expiratory Flow Dynamic spirometry test was performed, assessing the peak expiratory flow (PEF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting 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, 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 was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. twice: before and immediately after procedure administration in both groups
Primary Assessment of change of Peak Inspiratory Flow Dynamic spirometry test was performed, assessing the peak inspiratory flow (PIF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting 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, 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 was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. twice: before and immediately after procedure administration in both groups
Primary Assessment of change of Forced Vital Capacity Dynamic spirometry test was performed, assessing the forced vital capacity (FVC), measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting 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, 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 ". twice: before and immediately after procedure administration in both groups
Primary Assessment of change of Maximum Expiratory Flow. Dynamic spirometry test was performed, assessing the maximum expiratory flow (MEF), measured in liters per second. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting 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, 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 was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. twice: before and immediately after procedure administration in both groups
Primary Assessment of change of Forced Expiratory Volume Dynamic spirometry test was performed, assessing the forced expiratory volume in 1 s (FEV1) measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting 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, 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 was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. twice: before and immediately after procedure administration in both groups
Primary Assessment of change of Maximum Voluntary Ventilation Dynamic spirometry test was performed, assessing the maximum voluntary ventilation (MVV) measured in liters per minute. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting 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 was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. twice: before and immediately after procedure administration in both groups
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