Effects of Swedish Massage Prior Circuit Breathing Training on Asthma

Asthma; Status Clinical Trial

Official title:

Effects of Swedish Massage Prior Circuit Breathing Training on Asthma Control and Respiratory Function in Patients With Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407011
• Other study ID #: EX PHYSIO SPSC 10
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Chulalongkorn University
• Contact: Wannaporn Tongtako
• Phone: 0879823131
• Email: wannaporn.t[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to determine the effects of Swedish massage prior circuit breathing training on asthma control and respiratory function in patients with asthma.

Description:

Thirty patients with asthma aged 20-65 years were randomized into 3 groups: the control group (CON; n=10), the Circuit Breathing Training group (CBT; n=10), and the Swedish Massage prior to Circuit Breathing Training group (SBT; n=10). Participants in the CON group carried out their daily routine without receiving any training program. The CBT group received circuit breathing training sessions lasting thirty minutes each, three times a week for twelve weeks, while the SBT group received a Swedish massage (20 minutes) before circuit breathing exercises (30 minutes) three times a week for twelve weeks. Physiological data, pulmonary function, respiratory muscle strength, cytokine levels, Asthma Control Test scores, Visual Analogue Scale scores, chest expansion, and muscle flexibility variables were analyzed during the pre-test, post-test at 6 weeks, and post-tests at 12 weeks. Two-way repeated measures ANOVA was used to compare the variables between each test and between groups. Statistical significance was defined as p < .05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being a male or female patient with asthma who is between 20 and 65 years old.

• Being a patient who has been diagnosed by a doctor with asthma for at least 6 months.

• The severity of the disease has been assessed at levels 2 to 4, meaning the volume of air expelled in the first second of breathing quickly and with full force (Forced Expiratory Volume in one second; FEV1) is between 80% and 30% on the date of data collection. This has been certified by a doctor, and the patient is using medication according to the normal treatment plan.

• Must not have other respiratory diseases such as tuberculosis, lung cancer, emphysema, chronic obstructive pulmonary disease (COPD), etc.

• Should not have received exercise training for more than 20 minutes at a time, 3 days/week, or more in the past 6 months before participating in the research.

• Having no communication problems.

• The sample volunteers to participate in the research and agrees to sign the consent form to participate in the research.

Exclusion Criteria:

• Being a patient who has a history of asthma caused by exercise (Exercise-Induced Asthma).

• In case of a force majeure event that makes it impossible to continue participating in the research, such as injury from an accident or illness, etc.

• Participating in less than 80 percent of the training sessions (28 times out of 36 times) for the breathing training group and the group that practiced breathing together with massage.

• Unwillingness to continue participating in the research.

Related Conditions & MeSH terms

• Asthma
• Asthma; Status

Intervention

Other:
• Control
The CON group did not have any intervention but usual care.
• Swedish massage prior circuit breathing training group (SBT)
Participants Swedish massage prior circuit breathing training 3 days/week, 12 weeks. They perform Swedish massage using techniques such as stroking, kneading, and tapping the upper muscle area of the body for 20 minutes per day. Then, they do circuit breathing exercises for about 30 minutes per day, comprising 3 sets of 4 breathing exercises (triflow, power breath, windmill, and balloon blowing), with 1-minute rest between each exercise and 2 minutes between each set.
• Circuit breathing training group (CBT)
Participants perform circuit breathing exercises for about 30 minutes per day, 3 days/week, 12 weeks, comprising 3 sets of 4 breathing exercises (triflow, power breath, windmill, and balloon blowing), with 1-minute rest between each exercise and 2 minutes between each set.

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test : ACT	The Asthma Control Test (ACT) consists of 5 questions designed to assess asthma symptoms over the past 4 weeks. A score out of 25 points is given, with a high score indicating good asthma control. A score lower than 20 points indicates that the disease is not well controlled.	Change from baseline Asthma Control Test : ACT at 6 and 12 weeks.
Primary	The Mini Asthma Quality of Life Questionnaire: Mini AQLQ	The Mini Asthma Quality of Life Questionnaire (Mini AQLQ) aims to assess changes in life satisfaction related to health status over the past 2 weeks. It consists of a total of 15 questions divided into 4 areas: Signs and symptoms: 5 items, Environmental management: 3 items, Emotion management: 3 items, and Performance of daily activities: 4 items.	Change from baseline The Mini Asthma Quality of Life Questionnaire: Mini AQLQ at 6 and 12 weeks.
Primary	Pulmonary function (Forced vital capacity; FVC)	The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FVC will be reported in liter (L).	Change from baseline FVC at 6 and 12 weeks.
Primary	Pulmonary function (Forced Expiratory Volume in one second; FEV1)	The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).	Change from baseline FEV1 at 6 and 12 weeks.
Primary	Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)	The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).	Change from baseline FEV1/FVC at 6 and 12 weeks.
Primary	Pulmonary function (Maximal voluntary ventilation; MVV)	The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).	Change from baseline MVV at 6 and 12 weeks.
Primary	Respiratory muscle strength	Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.	Change from baseline Respiratory muscle strength at 6 and 12 weeks.
Secondary	Fractional exhaled nitric oxide	Participants inhaled deeply for two to three seconds before exhaling slowly. Normally, it took 10 seconds to exhale.	Change from baseline Fractional exhaled nitric oxide at 6 and 12 weeks.
Secondary	Blood chemical data test	Draw 10 milliliters of blood to analyze blood biochemistry, including interleukin-4 (IL-4), interleukin-5 (IL-5), and interleukin-13 (IL-13).	Change from baseline Blood chemical data at 6 and 12 weeks.
Secondary	Chest expansion	The subjects were asked to sit upright with their hands on their hips. They were then asked to exhale fully and inhale fully. The researcher will use a tape measure to measure the expansion of the chest at various levels, including the upper chest at axillary line, midway between the 2nd and 4th ribs, the middle chest at the level of xiphoid process, midway between Ribs 4 - 6, and the lower thorax at the level of the 10th rib.	Change from baseline chest expansion at 6 and 12 weeks.
Secondary	Trunk flexion	Ask the research participant to stand upright. Then, the researcher will take a tape measure and measure the C7 - S1 position and record the measured value. Next, instruct the participants to slowly bend their torso without bending their knees as much as possible, and then read the measurements on the measuring tape and record them.	Change from baseline trunk flexion at 6 and 12 weeks.
Secondary	Trunk extension	The participants stood up straight, then the researcher took a tape measure and measured the positions C7 - S1, recording the measured values. The subjects were then instructed to slowly stretch their torso as much as possible without stretching their hips or rotating their torso, and then to read the measurement after stretching their back.	Change from baseline trunk extension at 6 and 12 weeks.
Secondary	Neck flexion	The participant stood upright, and the researcher placed the goniometer's pivot point over the participant's ear. Then, instruct the participant to slowly bow his or her head with the chin as close to the neck as possible, while placing the goniometer over the tip of the participant's nose. Measure and record the data.	Change from baseline neck flexion at 6 and 12 weeks.
Secondary	Neck extension	The participant tilted their head as far back as possible. Then, the researcher placed the goniometer's pivot point over the participant's ear, extending the goniometer over the tip of the participant's nose. Measure and record the data.	Change from baseline neck extension at 6 and 12 weeks.