- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459153
Multiple Breathing Training on Pulmonary Function and Respiratory Muscle Strength in Older Adults
Effects of Multiple Breathing Training on Pulmonary Function and Respiratory Muscle Strength in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study included 26 male and female older adults aged 60-75 years, who were divided into a control group (n = 13) that maintained usual daily activities and an experimental group (n = 13) that received multiple breathing training.
The independent variable was multiple breathing training. Dependent variables included lung function (FVC, FEV₁, FEV₁/FVC, MVV), respiratory muscle strength (MIP, MEP), chest expansion, fractional exhaled nitric oxide (FeNO), aerobic capacity, and dyspnea assessment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10330
- Faculty of Sports Science, Chulalongkorn University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults aged 60-75 years, both male and female.
- Not regularly physically active (exercising fewer than 2 times per week) during the 6 months prior to the study.
- Cooperative, without communication problems, and able to follow instructions from the trainer.
- No history of cardiovascular disease and no respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), etc.
- No hypertension, or if diagnosed with hypertension, it must be well controlled, with resting blood pressure not exceeding 140 mmHg systolic and 90 mmHg diastolic.
- Able to ambulate independently without assistance or assistive devices.
- Willing to participate in the study and able to provide written informed consent.
Exclusion Criteria:
- Any unforeseen events preventing continued participation in the study, such as injury from an accident or illness.
- Attendance of less than 80% of the training sessions (fewer than 19 out of 24 sessions, including the basic training period).
- Withdrawal of consent or unwillingness to continue participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group (Normal daily life)
|
|
|
Experimental: Multiple breathing training
The multiple breathing training program consisted of five structured breathing exercises designed to improve inspiratory muscle strength, expiratory muscle strength, and breath control. Each exercise was performed for three sets, and the total training duration was approximately 40 minutes per session. The program included the following components: Inspiratory Muscle Training (PowerBreathe device): Participants performed resisted inhalation to strengthen the inspiratory muscles (10 repetitions per set). Expiratory Muscle Training (Balloon with control device): Participants exhaled into a balloon while maintaining pressure according to their measured maximal expiratory pressure (MEP) (10 repetitions per set). Inspiratory Training (Tri-Flow device): Participants inhaled through the device to elevate and maintain the floating balls, promoting sustained inspiratory effort (10 repetitions per set). Expiratory Training (Windmill device): Participants exhaled to rotate the windmill, |
The multiple breathing training program consisted of five structured breathing exercises designed to improve inspiratory muscle strength, expiratory muscle strength, and breath control. Each exercise was performed for three sets, and the total training duration was approximately 40 minutes per session. The program included the following components: Inspiratory Muscle Training (PowerBreathe device): Participants performed resisted inhalation to strengthen the inspiratory muscles (10 repetitions per set). Expiratory Muscle Training (Balloon with control device): Participants exhaled into a balloon while maintaining pressure according to their measured maximal expiratory pressure (MEP) (10 repetitions per set). Inspiratory Training (Tri-Flow device): Participants inhaled through the device to elevate and maintain the floating balls, promoting sustained inspiratory effort (10 repetitions per set). Expiratory Training (Windmill device): Participants exhaled to rotate the windmill, e |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity; FVC
Time Frame: Change from Baseline FVC at 8 weeks.
|
Participants were seated in a chair and wore a nasal clip during the assessment.
They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.
|
Change from Baseline FVC at 8 weeks.
|
|
Forced Expiratory Volume in One second; FEV1
Time Frame: Change from Baseline FEV1 at 8 weeks.
|
Participants were seated in a chair and wore a nasal clip during the assessment.
They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.
|
Change from Baseline FEV1 at 8 weeks.
|
|
Maximum Voluntary Ventilation; MVV
Time Frame: Change from Baseline MVV at 8 weeks.
|
Participants were instructed to breathe in and out as quickly and forcefully as possible for 15 seconds.
|
Change from Baseline MVV at 8 weeks.
|
|
Maximal Inspiratory Pressure; MIP
Time Frame: Change from Baseline MIP at 8 weeks.
|
Participants were instructed to exhale fully to functional residual capacity (FRC), then place the mouthpiece securely and perform a maximal inspiratory effort sustained for 1-2 seconds.
|
Change from Baseline MIP at 8 weeks.
|
|
Maximal expiratory pressure; MEP
Time Frame: Change from Baseline MEP at 8 weeks.
|
Participants inhaled fully to total lung capacity (TLC), maintained a tight seal on the mouthpiece, and then performed a maximal expiratory effort for 1-2 seconds.
|
Change from Baseline MEP at 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest expansion
Time Frame: Change from Baseline Chest expansion at 8 weeks.
|
Participants were instructed to sit upright with their hands placed on their hips.
They were then asked to perform a maximal exhalation followed by a maximal inhalation.
The researcher measured chest expansion using a measuring tape at the following anatomical levels: upper chest: at the axillary line, midway between the 2nd and 4th ribs, middle chest: at the level of the xiphoid process, midway between the 4th and 6th ribs, and lower chest: at the level of the 10th rib.
|
Change from Baseline Chest expansion at 8 weeks.
|
|
Fraction exhaled nitric oxide; FeNO
Time Frame: Change from Baseline FeNO at 8 weeks.
|
FeNO Monitor (BedFont, UK) was used to measure the FeNO.
The participants inhaled deeply for 2 to 3 seconds before exhaling slowly, which normally took 10 seconds.
|
Change from Baseline FeNO at 8 weeks.
|
|
Six minutes walk test (6MWT)
Time Frame: Change from Baseline 6MWT at 8 weeks.
|
They were instructed to walk back and forth along a 30-meter walkway for six minutes at their usual, comfortable pace.
The researcher marked the course every 3 meters and placed traffic cones at the turning points.
Heart rate was monitored during the test, and the level of perceived exertion was assessed every minute.
The total distance walked in six minutes was recorded for analysis.
|
Change from Baseline 6MWT at 8 weeks.
|
|
The University of California, SanDiego Shorthess of Breath Questionnaire (SOBQ)
Time Frame: Change from Baseline SOBQ at 8 weeks.
|
Participants completed a six-item dyspnea questionnaire before and after the intervention.
Each item was rated on a 0-5 scale, with a maximum total score of 30 points.
Scores were interpreted as follows: 0-10 indicated no to mild breathlessness, 11-20 indicated mild to moderate breathlessness, and 21-30 indicated moderate to severe breathlessness.
|
Change from Baseline SOBQ at 8 weeks.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jun HJ, Kim KJ, Nam KW, Kim CH. Effects of breathing exercises on lung capacity and muscle activities of elderly smokers. J Phys Ther Sci. 2016 Jun;28(6):1681-5. doi: 10.1589/jpts.28.1681. Epub 2016 Jun 28.
- Gosselink R. Breathing techniques in patients with chronic obstructive pulmonary disease (COPD). Chron Respir Dis. 2004;1(3):163-72. doi: 10.1191/1479972304cd020rs.
- Chung Y, Huang TY, Liao YH, Kuo YC. 12-Week Inspiratory Muscle Training Improves Respiratory Muscle Strength in Adult Patients with Stable Asthma: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Mar 22;18(6):3267. doi: 10.3390/ijerph18063267.
- Jansang S, Mickleborough T, Suksom D. Effects of Pursed-Lip Breathing Exercise Using Windmill Toy on Lung Function and Respiratory Muscle Strength in the Elderly. J Med Assoc Thai. 2016 Sep;99(9):1046-51.
- Hess A, Yu L, Klein I, De Mazancourt M, Jebrak G, Mal H, Brugiere O, Fournier M, Courbage M, Dauriat G, Schouman-Clayes E, Clerici C, Mangin L. Neural mechanisms underlying breathing complexity. PLoS One. 2013 Oct 3;8(10):e75740. doi: 10.1371/journal.pone.0075740. eCollection 2013.
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Other Study ID Numbers
- EX PHYSIO SPSC 13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Older Adults (60 - 85 Years Old)
-
Ondokuz Mayıs UniversityRecruitingOlder Adults (60 - 85 Years Old)Turkey (Türkiye)
-
KTO Karatay UniversityRecruitingOlder Adults (60 - 85 Years Old)Turkey (Türkiye)
-
University of VermontNot yet recruitingOlder Adults (60 - 85 Years Old)
-
University Hospital Southampton NHS Foundation...CompletedOlder Adults (60 - 85 Years Old)United Kingdom
-
Boung-hyoun MoonCompletedEffect of Exercise of Shoulder - Pelvic Coupling Pattern on Breathing Using Proprioceptive TechniqueOlder Adults (60 - 85 Years Old)South Korea
-
Masaryk UniversityRecruitingMild Cognitive Impairment (MCI) | Older Adults (60 - 85 Years Old)Czechia
-
University of Colorado, DenverDana-Farber Cancer Institute; NYU Langone Health; Emory University; National Institute... and other collaboratorsRecruitingHealthy Volunteer | Older Adults (65-85 Years)United States
-
Universidad del Valle de México, Campus CuernavacaCompletedOA Knee | Older Adults (60 - 85 Years Old)Mexico
-
University of SurreyRecruitingGenerally Healthy Adults Over 60 Years OldUnited Kingdom
-
Dr. Chris GaffneyNot yet recruitingColorectal Cancer | Chemotherapy | Physically Inactive | Older Adults (60 - 85 Years Old)United Kingdom
Clinical Trials on Multiple breathing training
-
Khon Kaen UniversityThai health promotion foundation.Terminated
-
Universität des SaarlandesUniversity Hospital, Basel, SwitzerlandRecruitingHyperventilation | HypoventilationGermany
-
Khon Kaen UniversityCompletedSystolic Essential HypertensionThailand
-
Università degli Studi di SassariCompletedMultiple Sclerosis | Fatigue | WeaknessItaly
-
US Department of Veterans AffairsCompleted
-
Royal Brompton & Harefield NHS Foundation TrustUnknown
-
Foundation University IslamabadRecruiting
-
Syracuse UniversityCompleted
-
Riphah International UniversityCompletedCOVID-19 PandemicPakistan