NCT05655624

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

December 9, 2022

Last Update Submit

January 31, 2023

Conditions

Keywords

Borg's scaleDyspneaIPAQMat Pilatesobese womenThoracoabdominal expansion

Outcome Measures

Primary Outcomes (3)

  • Borg scale (CR-10) Questionnaire

    It is valid questionnaire and is used to measure level of Dyspnea

    12 Weeks

  • Thoracoabdominal expansion measurement through tape measuring tool (cirtometry).

    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

    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

Study Arms (2)

Group A

EXPERIMENTAL

Pursed lip Breathing along Mat Pilates Training

Other: Pursed lip Breathing along Mat Pilates

Group B

ACTIVE COMPARATOR

pursed lip breathing without Mat Pilates Training

Other: pursed lip breathing without Mat Pilates Training

Interventions

Experimental Group: will be treated with Pursed lip Breathing along Mat Pilates Training.

Group A

Control Group will be treated pursed lip breathing without Mat Pilates Training

Group B

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age(25-55 years)
  • Female
  • Dyspnea during intense exercise 0-10
  • No experience of Pilates exercise training
  • BMI \> 30 kg/m2

You may not qualify if:

  • Smoking
  • Pregnancy
  • Practice of high intensity endurance training (squats, planks, lunges)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Star Gym for Women Al- Rehman Garden Community

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 9481598BACKGROUND
  • Bray GA. Medical consequences of obesity. J Clin Endocrinol Metab. 2004 Jun;89(6):2583-9. doi: 10.1210/jc.2004-0535.

    PMID: 15181027BACKGROUND
  • 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.

    PMID: 19127177BACKGROUND
  • 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.

    PMID: 30033163BACKGROUND
  • 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.

    PMID: 27210841BACKGROUND
  • 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.

    PMID: 30624373BACKGROUND
  • 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.

    PMID: 29083130BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hafiza Muriam Ghani, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 19, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 30, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations