- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07628400
Comparative Effects of Hypopressive and Split Tummy Exercises in Postpartum Diastasis Recti
Comparative Effects of Hypopressive and Split Tummy Exercises on Lifestyle, Inter Recti Distance, Strength and Function of Pelvic Floor Muscles in Postpartum Diastasis Recti
연구 개요
상세 설명
Postpartum diastasis recti abdominis (DRA) is a common condition affecting women after childbirth, characterized by the separation of the rectus abdominis muscles along the linea alba. This condition can lead to core instability, pelvic floor dysfunction, back pain, and a negative impact on daily function and quality of life. Rehabilitation through exercise is considered a primary non-surgical treatment. However, the most effective approach to improving both physical parameters and overall lifestyle remains under investigation.
To compare the effects of hypopressive exercises and split tummy (transverse abdominal activation-based) exercises on inter-recti distance (IRD), pelvic floor muscle strength and function, and overall quality of life improvements in postpartum women with diastasis recti. This study will be randomized clinical trial and will be conducted in Hameed Latif Hospital Lahore and Civil Hospital Sukkur. The total duration of treatment will be 8 week. Non-probability convenience sampling technique will be used and 50 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive hypopressive exercise with baseline treatment abdominal binding. Group B will receive baseline treatment with split tummy exercises. The tools that will be used are digital vernier scale use for inter recti distance, oswestry disability index (ODI), Oxford Grading scale system use for strength and function of pelvic floor muscles and quality of life questionnaire. Data will be analyzed using SPSS version 21. With the significant P value < 0.05.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Imran Amjad, PhD
- 전화번호: 03324390125
- 이메일: imran.amjad@riphah.edu.pk
연구 장소
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Punjab Province
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Sukkur, Punjab Province, 파키스탄, 65200
- 모병
- Civil Hospital Sukkur
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수석 연구원:
- Sarah Abid, MSWHPT
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age: 24 to 40years
- Weight: 50 to 70kg
- Height: 4.5 to 6ft
- BMI: Both underweight and overweight/ obese individuals can experience DRA.
- Parity: Multiparous
- Mode of delivery: vaginal delivery in split tummy.
- Subjects who gave vaginal birth with or without episiotomy in multiparous women in hypopressive.
Exclusion Criteria:
- Undergoing a severe illness
- Uncompleted inter-rectus distance (IRD) records
- Have a history of pelvic floor dysfunction
- Primiparous, polyhydramnios, uterine fibroids during pregnancy, previous abdominal, surgery caesarean delivery
- Subjects with untreated high blood pressure, cardiovascular illness, hernia, pregnant and underwent any recent surgeries.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: hypopressive exercise
For participants in Group A, series of postural and breathing-based sequences will be given.
Base-line is abdominal binding I will performed hypopressive exercises in various positions (lying, sitting, leaning forward, standing and quadruped) to improve breath control, abdominal contraction and pelvic floor engagement.
Each session began with focused breathing, full increasing based on tolerance.
Exercises were repeated in different postures to assess endurance in each, as individual holding each contraction 5 seconds and relax for 10 seconds capacity varied by position.
Participants engaged in these exercises for 20 minutes, 3 times per week, over a 8 week period, with moderate to high intensity based on breath-hold duration and postural demand.
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For participants in Group A, series of postural and breathing-based sequences will be given.
Base-line is abdominal binding I will performed hypopressive exercises in various positions (lying, sitting, leaning forward, standing and quadruped) to improve breath control, abdominal contraction and pelvic floor engagement.
Each session began with focused breathing, full increasing based on tolerance.
Exercises were repeated in different postures to assess endurance in each, as individual holding each contraction 5 seconds and relax for 10 seconds capacity varied by position.
Participants engaged in these exercises for 20 minutes, 3 times per week, over a 8 week period, with moderate to high intensity based on breath-hold duration and postural demand.
|
|
실험적: split tummy exercises
Base-line abdominal binding I will perform isometric exercises (1) Modified plank hold (2) Pelvic tilts (3) Transverse abdominis engagement.
For modified plank hold in this position participants with their knees on the ground instead of toes.
Engage core muscles and hold for 30 to 60 seconds.
For pelvic tilts participants lie on back with knees bent and feet flat on the floor.
Tilt the pelvic upwards and then back down again, repeating the motion in a slow and controlled manner.
Hold for 30 to 60 seconds.
For transverse abdominis engagement participants lies on back with knees bent and feet flat on the floor.
Engage transverse abdominis muscle and drawing belly button towards spine.
Hold for 30 to 60 seconds.
3 times in a week involving at least three sets of 10 repetitions each.
To improved core strength and stability, increased muscle endurance and isometric exercises can be low-impact, making them suitable for individuals with diastasis recti.
|
Base-line abdominal binding I will perform isometric exercises (1) Modified plank hold (2) Pelvic tilts (3) Transverse abdominis engagement.
For modified plank hold in this position participants with their knees on the ground instead of toes.
Engage core muscles and hold for 30 to 60 seconds.
For pelvic tilts participants lie on back with knees bent and feet flat on the floor.
Tilt the pelvic upwards and then back down again, repeating the motion in a slow and controlled manner.
Hold for 30 to 60 seconds.
For transverse abdominis engagement participants lies on back with knees bent and feet flat on the floor.
Engage transverse abdominis muscle and drawing belly button towards spine.
Hold for 30 to 60 seconds.
3 times in a week involving at least three sets of 10 repetitions each.
To improved core strength and stability, increased muscle endurance and isometric exercises can be low-impact, making them suitable for individuals with diastasis recti.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Digital Vernier Calliper
기간: 8 weeks
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The Oswestry Disability Index (ODI) and inter-recti distance were measured at the start (baseline) and again at the 8th week.
A digital vernier caliper was used to assess the inter-recti distance at three specific locations: directly at the umbilicus, 4.5 cm above, and 4.5 cm below it.
The ODI evaluates functional disability based on ten factors: pain intensity, ability to maintain personal hygiene, lifting, work, standing, sitting, sleeping, sexual activity, social interaction, and travel.
ODI scores range as follows: 0-20% indicates minimal disability, 21-40% suggests moderate disability, 41-60% reflects severe disability, 61-80% indicates significant functional limitation, and 81-100% implies the patient is confined to bed.
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8 weeks
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Quality of life questionnaire
기간: 8 weeks
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The SF-36 is regarded as a valid and reliable tool with strong discriminatory and convergent validity that allows it to differentiate across respondent groups according to age, gender, and socioeconomic position.
It has eight sub scales and 36 items.
(1) Physical functioning (PF), (2) Role-physical (RP), (3) Bodily pain (BP), (4) General health (GH), (5) Vitality (VT), (6) Social functioning (SF), (7) Role-emotional (RE), and (8) Emotional wellbeing (EW).
Higher ratings on each subscale, which range from 0 to 100, indicate better conditions .
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8 weeks
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Pelvic floor strength and function
기간: 8 weeks
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Digital assessment of PFM strength using the Oxford Grading Scale system will distributed as follows: weak (n = 1), moderate (n = 6), good (n = 10) and strong (n = 26)(16).
The reliability of oxford grading scale system is 0.53.
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8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hafiza Iqra Rubab, MSWHPT, Riphah International University
간행물 및 유용한 링크
일반 간행물
- Abdullah, Rehman KA, Ahmad B, Arshad MK, Saeed H, Keen MA, Anwar A, Saleem NUA, Salma Shabbar Banatwala UE, Bilal Z, Shahzad M, Shakoor P, Niazi MA. Comparative Efficacy of Abdominal Exercises and Abdominal Binding on Diastasis Recti Abdominis Reduction in Postpartum Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Physiother Res Int. 2025 Apr;30(2):e70038. doi: 10.1002/pri.70038.
- Rodriguez-Romero B, Senin-Camargo F, Sande-Fuentes J, Martinez-Bustelo S. Exercises to treat diastasis rectus abdominis and improve abdominal function: Two case reports. J Back Musculoskelet Rehabil. 2025 Sep;38(5):1180-1188. doi: 10.1177/10538127251325839. Epub 2025 Apr 10.
- Theodorsen NM, Moe-Nilssen R, Bo K, Haukenes I. Effect of exercise on the inter-rectus distance in pregnant women with diastasis recti abdominis: an experimental longitudinal study. Physiotherapy. 2023 Dec;121:13-20. doi: 10.1016/j.physio.2023.08.001. Epub 2023 Aug 23.
- Sekar R, Ramalingam V, Nirmala JG, Muniandy Y. Effectiveness of Abdominal Hypopressive Technique on Diastasis Recti among Postpartum Women. Indian Journal of Physiotherapy & Occupational Therapy. 2024;18.
- Shohaimi S, Husain NRN, Zaki FM, Atan IK. Split Tummy Exercise Program for Reducing Diastasis Recti in Postpartum Primigravidae: A Randomized Controlled Trial. Korean J Fam Med. 2023 Mar;44(2):102-108. doi: 10.4082/kjfm.22.0035. Epub 2023 Mar 20.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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