The Effect of Deep Tissue Massage on Respiratory Parameters in People With Asthma

NCT06893445 | Not Yet Recruiting

• 1 other identifier: 118.0043.1.81.2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Massage; Asthma Patients

Keywords

deep tissue massage; spirometry; asthma; respiratory parameters

Outcome Measures

Primary Outcomes (8)

• Assessment of change of lung vital capacity

  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.

  twice: before and immediately after procedure administration in both groups

• Assessment of change of chest circumference

  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.

  twice: before and immediately after procedure administration in both groups

• Assessment of change of blood oxygen saturation

  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%.

  twice: before and immediately after procedure administration in both groups

• Asessment of change of Peak Expiratory Flow (PEF)

  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.

  twice: before and immediately after procedure administration in both groups

• Assessment of change of Forced Vital Capacity

  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 ".

  twice: before and immediately after procedure administration in both groups

• Assessment of change of Maximum Expiratory Flow

  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.

  twice: before and immediately after procedure administration in both groups

• Assessment of change of Forced Expiratory Volume in one second

  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.

  twice: before and immediately after procedure administration in both groups

• Assessment of change of Maximum Voluntary Ventilation

  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.

  twice: before and immediately after procedure administration in both groups

Study Arms (2)

Deep Tissue Massage Group

EXPERIMENTAL

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.

Procedure: Deep Tissue Massage

Classic Massage Group

ACTIVE COMPARATOR

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.

Procedure: Classic massage

Interventions

Deep Tissue Massage PROCEDURE

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.

Deep Tissue Massage Group

Classic massage PROCEDURE

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.

Classic Massage Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with bronchial asthma
• stable health condition, allowing participation in the study
• informed consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (2)

Department of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College

Krakow, Poland

Location

The "Wieliczka" Salt Mine Health Resort

Wieliczka, Poland

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bartosz T Trybulec, PhD

  Jagiellonian University

  STUDY DIRECTOR

Central Study Contacts

Bartosz T Trybulec, PhD

CONTACT

12 422 56 83; bartosz.trybulec@uj.edu.pl

Sarah Duk, MSc

CONTACT

sarah.duk@doctoral.uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)