Effects of Swedish Massage Prior Circuit Breathing Training on Asthma

NCT06407011 | Active Not Recruiting DMC

• 1 other identifier: EX PHYSIO SPSC 10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Status

Keywords

Asthma; Circuit breathing; Swedish massage; Pulmonary function; Asthma control

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (7)

• Fractional exhaled nitric oxide

  Change from baseline Fractional exhaled nitric oxide at 6 and 12 weeks.

• Blood chemical data test

  Change from baseline concentration of cytokines in serum of interleukin-4 (IL-4), interleukin-5 (IL-5), and interleukin-13 (IL-13) at 6 and 12 weeks.

• Chest expansion

  Change from baseline chest expansion at 6 and 12 weeks.

• Trunk flexion

  Change from baseline trunk flexion at 6 and 12 weeks.

• Trunk extension

  Change from baseline trunk extension at 6 and 12 weeks.

Study Arms (3)

Control

SHAM COMPARATOR

The CON group did not have any intervention but usual care.

Other: Control

Swedish massage prior circuit breathing training group (SBT)

EXPERIMENTAL

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.

Other: Swedish massage prior circuit breathing training group (SBT)

Circuit breathing training group (CBT)

EXPERIMENTAL

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.

Other: Circuit breathing training group (CBT)

Interventions

Control OTHER

The CON group did not have any intervention but usual care.

Control

Swedish massage prior circuit breathing training group (SBT) OTHER

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.

Swedish massage prior circuit breathing training group (SBT)

Circuit breathing training group (CBT) OTHER

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.

Circuit breathing training group (CBT)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

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

• Wannaporn Tongtako

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 5, 2024
• Primary Completion: August 10, 2024
• Study Completion: August 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)