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Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program

Primary Purpose

Pelvic Floor Muscle Weakness, Endurance, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Diaphragmatic breathing exercises
Abdominal muscle strengthening exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Muscle Weakness focused on measuring Abdominal Muscles, Breathing Exercises, Exercise, Pelvic Floor, Quality Of Life

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 20 to 35 years.
  • Women between 2 to 6 months post-natal.
  • Women with stable somatic state.
  • Women with no cognitive dysfunction.

Exclusion Criteria:

  • Women with respiratory problems.
  • Women with severe back pain.
  • Patients with any pelvic pathology
  • Patient with any previous neurological disorders

Sites / Locations

  • Islamic Center Sialkot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diaphragmatic breathing in combination with abdominal muscle strengthening exercises

Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises

Arm Description

Exprimental Group ( Group A) will receive diaphragmatic breathing in combination with abdominal muscle strengthening exercises .12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Active comparator (Group B) will receive diaphragmatic breathing only. 12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Outcomes

Primary Outcome Measures

PERFECT scheme questionnaire
The term PERFECT stands for power (or pressure), endurance (E), repetitions (R), rapid contractions (F), and lastly, every contraction timed (ECT). The Pelvic Floor Muscle Assessment Scheme was created to streamline and explain the process. This program may provide suggestions for developing patient-specific exercise plans that correspond to the principles of muscle training."
SF-36 quality of life questionnaire
Physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) are the eight scales that the SF-36 measures. Different amounts from each scale do go into the scoring of the PCS and MCS measures.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2022
Last Updated
December 13, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05474469
Brief Title
Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program
Official Title
Effects of Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program on Pelvic Floor Strength, Endurance and Quality of Life in Postnatal Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The postpartum period is excessively weak and have hypotonic abdominal muscles, making the ligaments and connective tissue softer and more elastic. The importance of exercise in the postpartum period is very important in this regard. This study will be a Randomized control trial used to compare the effects of diaphragmatic breathing with and without abdominal muscles strength training program on pelvic floor strength and endurance and quality of life in postnatal women. Subjects meeting the inclusion and exclusion criteria will be divided into two groups using lottery method. Assessment will be done using PERFECT scheme questionnaire and SF- 36 quality of life questionnaire. Subjects in one group will receive diaphragmatic breathing exercises along with pelvic muscle strength training and subjects in other group will receive only diaphragmatic breathing exercises. Each subject will receive 12 treatment sessions for 4 weeks. Results will be analyzed for any change by using SPSS25.
Detailed Description
The postpartum period is excessively weak and have hypotonic abdominal muscles, making the ligaments and connective tissue softer and more elastic. These changes result in anatomical, physiological and biomechanical alterations. Therefore, these factors are responsible for the lack of necessary support for the waist region, pain, disability and negative impact on health-related quality of life. The importance of exercise in the postpartum period is very important in this regard. Postnatal exercises have several benefits such as improving pelvic floor strength and endurance and quality of life and increasing the general well-being, preventing the diastasis of the rectus Abdominis muscle (RAM) increasing cardiovascular endurance and bone mineral density. This study will be a Randomized control trial used to compare the effects of diaphragmatic breathing with and without abdominal muscles strength training program on pelvic floor strength and endurance and quality of life in postnatal women. Subjects meeting the inclusion and exclusion criteria will be divided into two groups using lottery method. Assessment will be done using PERFECT scheme questionnaire and SF- 36 quality of life questionnaire. Subjects in one group will receive diaphragmatic breathing exercises along with pelvic muscle strength training and subjects in other group will receive only diaphragmatic breathing exercises. Each subject will receive 12 treatment sessions for 4 weeks. Results will be analyzed for any change by using SPSS25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Muscle Weakness, Endurance, Quality of Life
Keywords
Abdominal Muscles, Breathing Exercises, Exercise, Pelvic Floor, Quality Of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic breathing in combination with abdominal muscle strengthening exercises
Arm Type
Experimental
Arm Description
Exprimental Group ( Group A) will receive diaphragmatic breathing in combination with abdominal muscle strengthening exercises .12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
Arm Title
Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises
Arm Type
Active Comparator
Arm Description
Active comparator (Group B) will receive diaphragmatic breathing only. 12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing exercises
Intervention Description
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
Intervention Type
Other
Intervention Name(s)
Abdominal muscle strengthening exercises
Intervention Description
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
Primary Outcome Measure Information:
Title
PERFECT scheme questionnaire
Description
The term PERFECT stands for power (or pressure), endurance (E), repetitions (R), rapid contractions (F), and lastly, every contraction timed (ECT). The Pelvic Floor Muscle Assessment Scheme was created to streamline and explain the process. This program may provide suggestions for developing patient-specific exercise plans that correspond to the principles of muscle training."
Time Frame
4 Weeks
Title
SF-36 quality of life questionnaire
Description
Physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) are the eight scales that the SF-36 measures. Different amounts from each scale do go into the scoring of the PCS and MCS measures.
Time Frame
4 Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postnatal Women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20 to 35 years. Women between 2 to 6 months post-natal. Women with stable somatic state. Women with no cognitive dysfunction. Exclusion Criteria: Women with respiratory problems. Women with severe back pain. Patients with any pelvic pathology Patient with any previous neurological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Islamic Center Sialkot
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26329802
Citation
Gursen C, Inanoglu D, Kaya S, Akbayrak T, Baltaci G. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial. Arch Gynecol Obstet. 2016 Mar;293(3):557-65. doi: 10.1007/s00404-015-3862-3. Epub 2015 Sep 2.
Results Reference
background
PubMed Identifier
17416924
Citation
Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007 Apr;1101:266-96. doi: 10.1196/annals.1389.034. Epub 2007 Apr 7.
Results Reference
background
PubMed Identifier
22344353
Citation
Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
Results Reference
background
PubMed Identifier
33606844
Citation
Janakiraman B, Gebreyesus T, Yihunie M, Genet MG. Knowledge, attitude, and practice of antenatal exercises among pregnant women in Ethiopia: A cross-sectional study. PLoS One. 2021 Feb 19;16(2):e0247533. doi: 10.1371/journal.pone.0247533. eCollection 2021.
Results Reference
background
PubMed Identifier
34461383
Citation
Oliveira MC, Oliveira M, Silva H, Gomes A, Nascimento G, Marini G, Micussi MT. Evaluation of satisfaction of pelvic floor muscle training isolated and associated with tibial nerve stimulation in women with mixed urinary incontinence: A randomized, single-blinded clinical trial. Eur J Obstet Gynecol Reprod Biol. 2021 Oct;265:60-65. doi: 10.1016/j.ejogrb.2021.06.024. Epub 2021 Jun 24.
Results Reference
background

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Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program

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