- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07731724
Effects of Barre-Based Core Stability With and Without Tupler Technique on Core Strength, Inter Recti Distance, and Pelvic Floor Function Among Diastasis Recti Abdominis Patients
This study will be a single blind, parallel group randomized controlled trial designed to evaluate the effectiveness of Barre-based core stability training with and without the Tupler Technique in postpartum women with Diastasis Recti Abdominis. A total of 58 eligible participants will be recruited from postpartum care units and randomly assigned in a 1:1 allocation ratio to either an experimental group receiving Barre-based core stability training combined with the Tupler Technique or a control group receiving Barre-based core stability training alone.
Both interventions will be delivered under supervised conditions three times per week for 8 weeks, with each session lasting approximately 30-45 minutes. The Barre-based program focuses on controlled low impact movements aimed at improving deep core muscle activation, postural alignment, and neuromuscular coordination. The experimental group will additionally receive the Tupler Technique, which includes abdominal splinting, progressive core strengthening exercises, and neuromuscular re-education targeting approximation of the rectus abdominis muscles and improved abdominal wall function.
Outcome measures include inter-recti distance, core strength, and pelvic floor function. Secondary outcomes include postural stability and functional performance. Assessments will be conducted at baseline, mid-intervention (week 4), post-intervention (week 8), and follow-up (week 12) by blinded outcome assessors to minimize bias.
The purpose of this trial is to determine whether combining the Tupler Technique with Barre-based core stability training provides superior improvements in abdominal separation, core strength, pelvic floor function, and functional ability compared with Barre-based training alone in postpartum women.
Přehled studie
Postavení
Detailní popis
Diastasis Recti Abdominis (DRA) is a postpartum musculoskeletal condition characterized by separation of the rectus abdominis muscles due to weakening of the linea alba, resulting in impaired core stability, reduced pelvic floor function, altered lumbopelvic mechanics, and decreased functional performance. Management is primarily conservative and involves exercise-based rehabilitation targeting abdominal wall integrity and neuromuscular control.
Barre-based core stability training is a low impact exercise intervention focusing on postural alignment, controlled movement, and activation of deep core musculature, including the transversus abdominis and pelvic floor muscles. The Tupler Technique is a structured rehabilitation program for DRA that includes abdominal splinting, progressive core strengthening, and neuromuscular re-education to improve rectus abdominis approximation and abdominal wall function.
This single blind, parallel group randomized controlled trial will recruit 58 postpartum women diagnosed with DRA. Participants will be randomly allocated using concealed assignment in a 1:1 ratio to either an experimental group receiving Barre-based core stability training combined with the Tupler Technique or a control group receiving Barre-based training alone.
Both groups will receive supervised interventions three times per week for 8 weeks, with each session lasting 30-45 minutes. The exercise protocol emphasizes controlled activation of deep core muscles, postural control, and safe functional movement patterns. The experimental group will additionally perform abdominal splinting and structured neuromuscular re-education as part of the Tupler Technique.
Outcome measures will include inter-recti distance, core strength, pelvic floor function, postural stability, and functional performance. Assessments will be conducted at baseline, week 4, week 8, and week 12 by blinded outcome assessors. Data will be analyzed to compare within group and between group changes over time, using appropriate statistical methods under an intention-to-treat approach.
The study evaluates whether adding the Tupler Technique to Barre-based core stability training provides superior improvements in abdominal separation, core stability, pelvic floor function, postural control, and functional ability in postpartum women with Diastasis Recti Abdominis.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Hafsa Liaquat
- Telefonní číslo: 0349-4202195
- E-mail: hafsaliaquat39@gmail.com
Studijní záloha kontaktů
- Jméno: Dr. Sahar Fatima
- Telefonní číslo: 0327-1202200
- E-mail: Sahar.fatime@ubas.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán
- Nábor
- Punjab Rangers Teaching Hospital (PRTH), Ghurki Trust Teaching Hospital (GTTH)
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Kontakt:
- Shoaib Waqas
- Telefonní číslo: 03024552109
- E-mail: shoaib.waqas@ubad.edu.pk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria
- Women aged 18-40 years
- Postpartum period between 6-12 months
- Diagnosed with stage I-II Diastasis Recti Abdominis
- Presence of symptoms such as abdominal weakness or back pain
- Ability to follow exercise instructions Exclusion Criteria
- Stage III Diastasis Recti Abdominis
- Severe hernias or significant pelvic floor dysfunction
- Neurological, cardiovascular, or systemic conditions contraindicating exercise
- History of abdominal surgery or trauma affecting the abdominal wall
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Barre-Based Core Stability with Tupler Technique (BBT+TT)
Participants will receive supervised Barre-based core stability training combined with the Tupler Technique.
The Barre program will include low impact controlled exercises such as pelvic tilts, glute bridges, modified planks, lower limb core controlled movements, and functional standing exercises to improve deep core activation and postural control.
The Tupler Technique component will include abdominal splinting, elevator exercises, and structured neuromuscular re-education aimed at reducing inter recti distance and improving abdominal wall integrity.
Sessions will be conducted three times per week for 8 weeks, with each session lasting 30-45 minutes.
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Barre-Based Core Stability Training is a low impact, structured exercise intervention designed to improve deep core muscle activation, postural alignment, and functional stability.
It will include controlled movements such as pelvic tilts, glute bridges, modified planks, lower limb core-controlled exercises, and functional standing activities.
The program will emphasize activation of the transversus abdominis and pelvic floor muscles through slow, controlled, and alignment focused exercises.
Sessions will be conducted under supervision three times per week for 8 weeks, with each session lasting 30-45 minutes.
This intervention will aim to enhance core strength, improve neuromuscular coordination, and support overall lumbopelvic stability.
The Tupler Technique is a structured rehabilitation program specifically designed for the management of Diastasis Recti Abdominis.
It will include abdominal splinting, progressive core strengthening exercises, and neuromuscular re-education techniques.
The program will focus on activating and strengthening the transversus abdominis while promoting approximation of the rectus abdominis muscles to reduce inter-recti distance.
Key components will include elevator exercises, controlled core engagement, and the use of abdominal support during functional activities to enhance abdominal wall integrity.
In this study, the Tupler Technique will be delivered in combination with Barre-based training over 8 weeks with supervised sessions three times per week.
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Aktivní komparátor: Barre-Based Core Stability Training (BBT)
Participants will receive supervised Barre-based core stability training alone.
The program will include low-impact controlled exercises such as pelvic tilts, glute bridges, modified planks, lower limb core-controlled movements, and functional standing exercises aimed at improving deep core muscle activation, postural alignment, and functional stability.
No Tupler Technique components such as abdominal splinting or neuromuscular re-education will be included.
Sessions will be conducted three times per week for 8 weeks, with each session lasting 30-45 minutes.
|
Barre-Based Core Stability Training is a low impact, structured exercise intervention designed to improve deep core muscle activation, postural alignment, and functional stability.
It will include controlled movements such as pelvic tilts, glute bridges, modified planks, lower limb core-controlled exercises, and functional standing activities.
The program will emphasize activation of the transversus abdominis and pelvic floor muscles through slow, controlled, and alignment focused exercises.
Sessions will be conducted under supervision three times per week for 8 weeks, with each session lasting 30-45 minutes.
This intervention will aim to enhance core strength, improve neuromuscular coordination, and support overall lumbopelvic stability.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Inter-Recti Distance (IRD)
Časové okno: Baseline (Day 0), Week 4, Week 8, Week 12
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Inter-recti distance (IRD) will be measured to assess the separation of the rectus abdominis muscles in women with Diastasis Recti Abdominis.
Measurements will be taken using ultrasound imaging and calipers at standardized anatomical points (above, at, and below the umbilicus).
IRD will be recorded in centimeters.
A reduction in IRD indicates improvement in abdominal wall integrity and core stability.
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Baseline (Day 0), Week 4, Week 8, Week 12
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Core Strength
Časové okno: Baseline (Day 0), Week 4, Week 8, Week 12
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Core strength will be assessed using the Modified Sahrmann Test, which evaluates lumbopelvic control and activation of deep core muscles during progressive lower limb movements.
Performance will be scored based on the ability to maintain neutral spine alignment without compensatory movements such as pelvic tilt or abdominal bulging.
Higher scores indicate better core strength and neuromuscular control.
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Baseline (Day 0), Week 4, Week 8, Week 12
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Pelvic Floor Function
Časové okno: Baseline (Day 0), Week 4, Week 8, Week 12
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Pelvic floor function will be assessed using the Pelvic Floor Distress Inventory (PFDI-20), a validated questionnaire measuring symptom severity related to urinary, colorectal, and prolapse distress.
Scores range from 0 to 300, with higher scores indicating greater dysfunction.
A reduction in score indicates improvement in pelvic floor function.
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Baseline (Day 0), Week 4, Week 8, Week 12
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Postural Stability
Časové okno: Baseline (Day 0), Week 4, Week 8, Week 12
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Postural Stability Postural stability will be assessed using the Balance Error Scoring System (BESS).
Participants perform balance tasks in double-leg, single-leg, and tandem stance on firm and foam surfaces.
Errors (e.g., stepping, loss of balance, opening eyes) are counted.
Lower scores indicate better postural control.
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Baseline (Day 0), Week 4, Week 8, Week 12
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Functional Performance
Časové okno: Baseline (Day 0), Week 4, Week 8, Week 12
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Functional performance will be assessed using the Physical Functioning (PF-10) subscale of the SF-36 Health Survey.
The scale evaluates limitations in activities such as walking, climbing stairs, lifting, and carrying objects.
Scores range from 0 to 100, with higher scores indicating better functional ability.
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Baseline (Day 0), Week 4, Week 8, Week 12
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: WHO, Lahore University of Biological and Applied Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- UBAS/ERB/26/04/016
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