- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07642141
Combined Effects of Hypopressive Exercises and Abdominal Bracing on Diastasis Recti Outcomes
Combined Effects of Hypopressive Exercises and Abdominal Bracing on Interrecti Distance, Lumbopelvic Pain, and Abdominal Muscle Strength in Diastasis Recti
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Diastasis Recti Abdominis (DRA) is the separation of rectus abdominis muscles along the linea alba, which is common after childbirth due to the mechanical and hormonal changes that occur during pregnancy. DRA can affect posture, trunk stability, and breathing patterns, and may lead to persistent lumbopelvic pain and a weakened core if not managed properly. Although hypopressive exercises and abdominal bracing have individually shown promising results in reducing interrecti distance and improving core function, limited research is available on their combined effects. This study aims to evaluate the combined impact of hypopressive exercises and abdominal bracing on inter-recti distance, lumbopelvic pain, and abdominal muscle strength in postpartum women with DRA.
This study will be a randomized clinical trial. The study will be conducted at Jinnah Hospital, Lahore, over 10 months, involving a total of 34 postpartum women selected through non-probability convenience sampling. Participants will be randomly assigned to two groups: Group A will receive a combination of hypopressive exercises and abdominal bracing, and Group B will receive only hypopressive exercises. The hypopressive protocol includes diaphragmatic breathing cycles followed by rib cage expansion and a 10-second apnea, while the abdominal brace will be worn during waking hours for six weeks, except during bathing and exercising. Both groups will also receive standard postpartum physiotherapy. Outcome measures include the Numerical Pain Rating Scale (NPRS) to evaluate pain intensity, the Pelvic Girdle Questionnaire (PGQ) to assess lumbopelvic disability, Manual Muscle Testing (MMT) for abdominal muscle recti distance. Data will be analyzed using SPSS version 25, and with p-value of <0.05 will be considered statistically significant.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Imran Amjad, PHD*
- Numer telefonu: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Kopia zapasowa kontaktu do badania
- Nazwa: Imran Amjad, PHD*
- Numer telefonu: 0515481826
- E-mail: imran.amjad@riphah.edu.pk
Lokalizacje studiów
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Rekrutacyjny
- Jinnah Hospital
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Kontakt:
- Ghulam Fatima, PhD*
- Numer telefonu: 03034073057
- E-mail: ghulam.fatima@riphah.edu.pk
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Age group of 23 to 30 years
- Inter recti distance > 2 to 5 cm
- A women who had undergone a vaginal delivery at least 8 weeks before the first measurement
- A postpartum female with the presence of diastasis rectus abdominis
- BMI under or equal to 29kg/m2
Exclusion Criteria:
Pregnant females (29)
- Subjects who underwent any recent abdominal surgeries
- Patient diagnosed with a Fibroid uterus
- Patient diagnosed with abdominal hernia
- Cesarean section (C-section)
- Chronic medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, or thyroid disorders.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Group A: Hypopressive Exercise and Abdominal Bracing
The hypopressive exercise protocol included maintaining spinal elongation, a neutral pelvis, knee flexion, and scapular muscle activation. Participants performed diaphragmatic breathing followed by full expiration and a 10-second apnea with rib cage expansion, causing inward abdominal contraction without inhalation. Exercises were performed in lying, sitting, standing, kneeling, and four-point kneeling positions. Each exercise was repeated three times with 30-second rest intervals. The intervention lasted 6 weeks with 12 sessions. Participants in Group A also used an ITA-Med postnatal abdominal binder made of breathable elastic material. The binder covered the area from the pubis to the lower ribs and was worn during waking hours for 6 weeks, except during sleep and bathing. It was applied while lying down and adjusted for a snug but comfortable fit. Participants were instructed to avoid excessive tightness and monitor the skin for irritation. |
The hypopressive exercise protocol included maintaining spinal elongation, a neutral pelvis, knee flexion, and scapular muscle activation. Participants performed diaphragmatic breathing followed by full expiration and a 10-second apnea with rib cage expansion, causing inward abdominal contraction without inhalation. Exercises were performed in lying, sitting, standing, kneeling, and four-point kneeling positions. Each exercise was repeated three times with 30-second rest intervals. The intervention lasted 6 weeks with 12 sessions. Participants in Group A also used an ITA-Med postnatal abdominal binder made of breathable elastic material. The binder covered the area from the pubis to the lower ribs and was worn during waking hours for 6 weeks, except during sleep and bathing. It was applied while lying down and adjusted for a snug but comfortable fit. Participants were instructed to avoid excessive tightness and monitor the skin for irritation. |
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Aktywny komparator: Group B: Hypopressive Exercise only
Each exercise was performed during the expiratory phase and required the contraction of the pelvic floor muscles.
Participants were instructed to perform between 1 to 3 sets of 10 repetitions per exercise, holding each contraction for 5 seconds followed by 10 seconds of relaxation.
The number of sets and the difficult level were progressively adjusted over time.
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Each exercise was performed during the expiratory phase and required the contraction of the pelvic floor muscles.
Participants were instructed to perform between 1 to 3 sets of 10 repetitions per exercise, holding each contraction for 5 seconds followed by 10 seconds of relaxation.
The number of sets and the difficult level were progressively adjusted over time.
This treatment protocol will be performed over a time period of 6 weeks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Numerical Pain Rating Scale (NPRS)
Ramy czasowe: 6 weeks
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It is a standardized self-reporting scale consisting of a horizontal line used to estimate the subjective level of pain intensity.
It is a 11 point numerical scale, corresponding to the degree of pain.
0= no pain, 1-2-3 = mild pain, 4-5-6 = moderate pain, 7-8-9-10 = severe pain.
The patients will be asked to select from that 11 points numerical continuum the number that corresponds to their perceived pain intensity.
NPRS is considered a valid and reliable scale for measures of pain intensity.
NPRS has shown high test-retest (r=0.96 and 0.95 ) reliability.
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6 weeks
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Pelvic Girdle Questionnaire (PGQ)
Ramy czasowe: 6 weeks
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It is a straightforward tool with 25 items, 20 of which measure activity restrictions (the activity subscale) and 5 of which measure symptoms (the symptom subscale).
Every item is worth four points and is graded on a Likert scale with a range of 0 to 3. The PGQ has a maximum possible score of 75, which includes 15 for the symptom subscale and 60 for the activity subscale.
Three points are deducted from the maximum possible score for an item that has no response or a response of "not applicable."
The final figures are displayed as a percentage, with 0 denoting no disability and 100 denoting severe disability.
A worse result is indicated by a higher score.
PGQ is considered a valid and reliable scale for measuring disability.
PGQ has shown test-retest reliability ( 0.93 (activity), .91 (symptom).
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6 weeks
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Manual muscle testing (MMT)
Ramy czasowe: 6 weeks
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Manual muscle testing (MMT) is a widely used clinical method for assessing muscle strength by applying manual resistance to specific muscles or muscle groups and grading the response on a standardized 0-5 scale.
It is considered a valid and reliable tool, particularly effective in detecting moderate to severe muscle weakness.
Studies report high inter-rater reliability (ICC = 0.85-0.98)
and good intra-rater consistency when performed by trained clinicians, especially for muscle grades 3 and above.
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6 weeks
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Tape measure and Finger-Width Method
Ramy czasowe: 6 weeks
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The finger-width method and tape measure are commonly used clinical tools to assess diastasis recti postpartum.
The finger-width method shows good intra-rater reliability (Kappa > 0.7) but only moderate inter-rater reliability (Kappa ≈ 0.53) and limited validity compared to ultrasound.
In contrast, the tape measure method demonstrates excellent intra- and inter-rater reliability (ICC = 0.80-1.00)
and strong validity, with high correlation to ultrasound (r = 0.82-0.98).
While ultrasound remains the 14 gold standard, the tape measure is a more accurate and reliable clinical alternative than the finger-width method.
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6 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Muzzammil Akhtar, Riphah International University
Publikacje i pomocne linki
Publikacje ogólne
- Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016.
- Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
- Hsia M, Jones S. Natural resolution of rectus abdominis diastasis. Two single case studies. Aust J Physiother. 2000;46(4):301-307. doi: 10.1016/s0004-9514(14)60291-9.
- Mota P, Gil Pascoal A, Bo K. Diastasis recti abdominis in pregnancy and postpartum period. Risk factors, functional implications and resolution. Current women's health reviews. 2015;11(1):59-67
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- REC/RCR & AHS/25/0525
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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