- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05655624
Effects of Pursed Lip Breathing With and Without Mat Pilates Training in Obese Women
January 23, 2023 updated by: Riphah International University
Effects of Pursed Lip Breathing With and Without Mat Pilates Training on Dyspnea, Physical Health and Thoracoabdominal Expansion in Obese Women
Obesity is defined as BMI more than or equal to 30kg/m2.
It is responsible for manifestation of serious health problem.
Accumulation of adipose tissue in thorax and abdomen causes stiffness of chest, reduction in lung compliance and favoring airway closure.
As result, reduction in lung volume and capacity occurs which requires increased breathing to maintain adequate oxygenation.
These changes lead to limitations in activities of daily life.
A Randomized Control study will be conduct to see the effects of Pilates exercise and pursed lip breathing to improve the breathing and thoracoabdominal expansion.
The study will be completed within 10 months after approval of synopsis.
The sample size of 34 subjects will be taken: 17 with Pilates method and 17 without Pilates method with 12% attrition rate.
Pre assessment and Post assessment will be made through IPAQ questionnaire for physical activity measurement, Borg's scale (CR-10) for dyspnea measurement and Cirtometry for thoracoabdominal expansion.
Study will be conducted at Star gym for women Al-Rehman Garden community, Lahore.
Data will be analyzed through SPSS 25.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Star Gym for Women Al- Rehman Garden Community
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age(25-55 years)
- Female
- Dyspnea during intense exercise 0-10
- No experience of Pilates exercise training
- BMI > 30 kg/m2
Exclusion Criteria:
- Smoking
- Pregnancy
- Practice of high intensity endurance training (squats, planks, lunges)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: Group A
Pursed lip Breathing along Mat Pilates Training
|
Experimental Group: will be treated with Pursed lip Breathing along Mat Pilates Training.
|
Active Comparator: Group B
pursed lip breathing without Mat Pilates Training
|
Control Group will be treated pursed lip breathing without Mat Pilates Training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Borg scale (CR-10) Questionnaire
Time Frame: 12 Weeks
|
It is valid questionnaire and is used to measure level of Dyspnea
|
12 Weeks
|
Thoracoabdominal expansion measurement through tape measuring tool (cirtometry).
Time Frame: 12 Weeks
|
Thoracoabdominal expansion will be measured by means of cirtometry (tape measuring) by measuring three regions (axillary, xiphoid and abdominal).
|
12 Weeks
|
Physical activity measurement through IPAQ questionnaire( International Physical Activity Questionnaire
Time Frame: 12 Weeks
|
It is standardized Questionnaire to evaluate the Physical Activity of subjects.
Before starting of study, the activity behavior of the participants will be monitored through IPAQ questionnaire)
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Donnelly JE, Blair SN, Jakicic JM, Manore MM, Rankin JW, Smith BK; American College of Sports Medicine. American College of Sports Medicine Position Stand. Appropriate physical activity intervention strategies for weight loss and prevention of weight regain for adults. Med Sci Sports Exerc. 2009 Feb;41(2):459-71. doi: 10.1249/MSS.0b013e3181949333. Erratum In: Med Sci Sports Exerc. 2009 Jul;41(7):1532.
- Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and trends, 1960-1994. Int J Obes Relat Metab Disord. 1998 Jan;22(1):39-47. doi: 10.1038/sj.ijo.0800541.
- Bray GA. Medical consequences of obesity. J Clin Endocrinol Metab. 2004 Jun;89(6):2583-9. doi: 10.1210/jc.2004-0535.
- Vatwani A. Pursed Lip Breathing Exercise to Reduce Shortness of Breath. Arch Phys Med Rehabil. 2019 Jan;100(1):189-190. doi: 10.1016/j.apmr.2018.05.005. Epub 2018 Jul 19. No abstract available.
- Giacomini MB, da Silva AM, Weber LM, Monteiro MB. The Pilates Method increases respiratory muscle strength and performance as well as abdominal muscle thickness. J Bodyw Mov Ther. 2016 Apr;20(2):258-64. doi: 10.1016/j.jbmt.2015.11.003. Epub 2015 Nov 10.
- Parisien-La Salle S, Abel Rivest E, Boucher VG, Lalande-Gauthier M, Morisset J, Manganas H, Poirier C, Comtois AS, Dube BP. Effects of Pursed Lip Breathing on Exercise Capacity and Dyspnea in Patients With Interstitial Lung Disease: A RANDOMIZED, CROSSOVER STUDY. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):112-117. doi: 10.1097/HCR.0000000000000387.
- Campos JL, Vancini RL, Rodrigues Zanoni G, Barbosa de Lira CA, Santos Andrade M, Jacon Sarro K. Effects of mat Pilates training and habitual physical activity on thoracoabdominal expansion during quiet and vital capacity breathing in healthy women. J Sports Med Phys Fitness. 2019 Jan;59(1):57-64. doi: 10.23736/S0022-4707.17.07908-7. Epub 2017 Oct 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
January 15, 2023
Study Registration Dates
First Submitted
December 9, 2022
First Submitted That Met QC Criteria
December 9, 2022
First Posted (Actual)
December 19, 2022
Study Record Updates
Last Update Posted (Actual)
January 25, 2023
Last Update Submitted That Met QC Criteria
January 23, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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