Pelvic Floor Muscle WeaknessNCT05474469
Diaphragmatic Breathing With and Without Abdominal Muscles Strength Training Program
A study testing Diaphragmatic breathing exercises and Abdominal muscle strengthening exercises in people with Pelvic Floor Muscle Weakness and Endurance, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Endurance, Quality of Life
- What is being tested?
- Diaphragmatic breathing exercises and Abdominal muscle strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 35 years.
- Women between 2 to 6 months post-natal.
- Women with stable somatic state.
- Women with no cognitive dysfunction.
Who cannot join
- Women with respiratory problems.
- Women with severe back pain.
- Patients with any pelvic pathology
- Patient with any previous neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pelvic Floor Muscle Weakness, Endurance, Quality of Life
- Being tested
- Diaphragmatic breathing exercises, Abdominal muscle strengthening exercises
- Keywords
- Abdominal Muscles, Breathing Exercises, Exercise, Pelvic Floor, Quality Of Life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing exercisesOther
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
Abdominal muscle strengthening exercisesOther
12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing in combination with abdominal muscle strengthening exercises | Experimental | 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. Receives: Other: Diaphragmatic breathing exercises; Other: Abdominal muscle strengthening exercises |
| Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises | Active comparator | Active comparator (Group B) will receive diaphragmatic breathing only. 12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week. Receives: Other: Diaphragmatic breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 4 Weeks
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.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.Phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474469
- Sponsor's protocol ID
- REC/RCR & AHS/22/0509
- Status last verified
- Dec 2022
- First submitted
- 24 Jul 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26329802Ashton-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.
PubMed 17416924Bernardes 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.
PubMed 22344353Janakiraman 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.
PubMed 33606844Oliveira 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.
PubMed 34461383
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05474469
- Acronym / sponsor ID
- REC/RCR & AHS/22/0509
- Conditions
- Pelvic Floor Muscle Weakness, Endurance, Quality of Life
- Keywords
- Abdominal Muscles, Breathing Exercises, Exercise, Pelvic Floor, Quality Of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing in combination with abdominal muscle strengthening exercises | Experimental | Other: Diaphragmatic breathing exercises, Other: Abdominal muscle strengthening exercisesExprimental 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. |
| Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises | Active comparator | Other: Diaphragmatic breathing exercisesActive comparator (Group B) will receive diaphragmatic breathing only. 12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to 35 years.
- Women between 2 to 6 months post-natal.
- Women with stable somatic state.
- Women with no cognitive dysfunction.
Key exclusion criteria (4 listed)
- Women with respiratory problems.
- Women with severe back pain.
- Patients with any pelvic pathology
- Patient with any previous neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathing exercises12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week. | Other | Diaphragmatic breathing Exercises only without abdominal muscle strengthening exercises, Diaphragmatic breathing in combination with abdominal muscle strengthening exercises |
| Abdominal muscle strengthening exercises12 treatment sessions for 4 weeks period, which consisted of 03 treatment sessions per week. | Other | Diaphragmatic breathing in combination with abdominal muscle strengthening exercises |
Primary outcome
PERFECT scheme questionnaire
Time frame: 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."
SF-36 quality of life questionnaire
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 26329802Gursen 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.
- Background: PubMed 17416924Ashton-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.
- Background: PubMed 22344353Bernardes 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.
- Background: PubMed 33606844Janakiraman 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.
- Background: PubMed 34461383Oliveira 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.
- Individual participant dataSharing planned: No
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabiha Arshad, M.Phil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing exercises and Abdominal muscle strengthening exercises in people with Pelvic Floor Muscle Weakness and Endurance, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERFECT scheme questionnaire (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474469, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.