Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05474469
Collaborator
(none)
74
1
2
7.3
10.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diaphragmatic breathing exercises
  • Other: Abdominal muscle strengthening exercises
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diaphragmatic breathing in combination with abdominal muscle strengthening exercises

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.

Other: Diaphragmatic breathing exercises
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Other: Abdominal muscle strengthening exercises
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Active Comparator: Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises

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

Other: Diaphragmatic breathing exercises
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.

Outcome Measures

Primary Outcome Measures

  1. PERFECT scheme questionnaire [4 Weeks]

    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."

  2. SF-36 quality of life questionnaire [4 Weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Islamic Center Sialkot Sialkot Punjab Pakistan 51300

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, M.Phil, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05474469
Other Study ID Numbers:
  • REC/RCR & AHS/22/0509
First Posted:
Jul 26, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022