- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07751952
Comparative Effects of Telerehabilitation Versus In-Person Core Stability Training in Postpartum Women
10 augusti 2026 uppdaterad av: Riphah International University
Comparative Effects Of Telerehabilitation And In-Person Core Stability Training On Inter Recti Distance And Body Image In Postpartum Women.
Diastasis recti abdominis (DRA) is common among postpartum women and can negatively affect abdominal muscle function and body image.
Core stability exercises are widely recommended for postpartum rehabilitation; however, access to supervised physiotherapy may be limited.
Tele rehabilitation may improve accessibility while maintaining treatment effectiveness.
This randomized controlled trial compares tele rehabilitation-based and in-person supervised core stability exercise programs in postpartum women with diastasis recti.
The primary objective is to compare changes in inter-recti distance, while the secondary objective is to compare changes in body image after an 8-week intervention
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This randomized controlled trial aims to compare the effectiveness of tele rehabilitation-based versus in-person supervised core stability exercises in postpartum women diagnosed with diastasis recti abdominis.
Fifty-four participants will be randomly allocated to either a tele rehabilitation group or an in-person supervised exercise group.
Both groups will receive the same standardized 8-week core stability exercise program consisting of three supervised sessions per week.
Outcomes will be assessed at baseline and after completion of the intervention.
Primary outcome will be inter-recti distance measured using a digital nylon caliper.
Secondary outcome will be body image measured using the Body Image State Scale (BISS).
The findings will help determine whether tele rehabilitation provides comparable clinical outcomes to conventional supervised physiotherapy for postpartum rehabilitation.
Studietyp
Interventionell
Inskrivning (Beräknad)
54
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Dr.Rida Zafar, MSPT(WH)
- Telefonnummer: 0336-8753273
- E-post: rida.zafar@riphah.edu.pk
Studera Kontakt Backup
- Namn: Dr Summra Andleeb, MS-OMPT
- Telefonnummer: 0345-0617872
- E-post: rida.zafar@riphah.edu.pk
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 0423
- Rekrytering
- Lifezone medical and diagnostic center lahore
-
Kontakt:
- Dr.Rida Zafar
- Telefonnummer: 03368753273
- E-post: rida.zafar@riphah.edu.pk
-
Huvudutredare:
- Rida Ijaz
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria: Participants falling in this category would be recruited into the study.
- 6 weeks to 6 months postpartum
- Multiparous or primiparous
- Diagnosis of diastasis recti (IRD ≥ 2cm)/
- Able to use or operate digital/electronic devices
- With internet access and the ability to participate in remote group sessions.
Exclusion Criteria: Participants fall in this category would be excluded of the study.
- Significant musculoskeletal or systemic comorbidities i.e. diabetes mellitus, cardiovascular disease, Severe psychiatric disorders, Active malignancy.
- Prior major abdominal or pelvic surgery (except cesarean)
- Any Contraindications to exercise.
- Recent/Current pregnancy.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Telerehabilitation Group
Participants allocated to this arm will receive a hybrid telerehabilitation-based core stability exercise program over 8 weeks.
Baseline assessment will be conducted in a clinical setting prior to intervention.
The program consists of three sessions per week (45-60 minutes each) on non-consecutive days, including warm-up, structured core stability exercises, and cool-down.
|
Participants were assessed at baseline by a physiotherapist and attended supervised in-clinic follow-up sessions every two weeks to monitor progress and ensure correct exercise performance.
Individualized exercise demonstrations were recorded on participants' mobile devices to facilitate home-based practice.
The intervention consisted of an 8-week progressive postpartum exercise program beginning at 6 weeks postpartum, including pelvic floor muscle (Kegel) exercises, abdominal bracing, trtransversus abdominis (TrA) activation, and pelvic tilts.
Exercise dosage (sets, repetitions, hold time, and fast contractions) was progressively increased each week according to the study protocol to improve pelvic floor muscle strength, core stability, and lumbopelvic control.
|
|
Aktiv komparator: In-Person Exercise Group
Participants allocated to the in-person comparator arm will receive a supervised, clinic-based core stability exercise program for 8 weeks.
Baseline assessment will be conducted prior to initiation in a clinical setting.
|
Participants were assessed at baseline by a physiotherapist and participated in supervised in-person group exercise sessions for 8 weeks, beginning at 6 weeks postpartum.
The intervention followed the same progressive exercise protocol as the telerehabilitation group and included pelvic floor muscle (Kegel) exercises, abdominal bracing, transversus abdominis (TrA) activation, and pelvic tilts, with weekly progression in sets, repetitions, hold duration, and fast contractions.
The physiotherapist provided real-time supervision, exercise correction, and progression throughout the intervention.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Digital Nylon Caliper
Tidsram: Baseline (pre-Intervention) Post-Intervention (after 8 weeks)
|
Digital nylon calipers are recognized as both reliable and valid for measuring inter-recti distance (IRD), Measurements of inter recti distance will be taken at the umbilicus and at standardized points 4.5 cm above and 4.5cm below umbilicus.
|
Baseline (pre-Intervention) Post-Intervention (after 8 weeks)
|
|
Body Image Scale (BISS)
Tidsram: Baseline Post-Intervention (after 8 weeks)
|
The Body Image State Scale (15) is a validated, self-reported tool for assessing body image, satisfaction, and emotional responses.
BISS scoring uses the mean of the six items (each scored 1-9) with certain items reverse-scored (items 2, 4, and 6), and higher totals signal higher body satisfaction.
The scale is tested for reliability and validity in various populations, including postpartum women, with Cronbach's alpha generally reported around 0.82-0.83
for internal consistency.
|
Baseline Post-Intervention (after 8 weeks)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Rida Ijaz, MSPT(WH), Riphah International University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 augusti 2026
Primärt slutförande (Beräknad)
1 oktober 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
4 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
4 augusti 2026
Första postat (Faktisk)
7 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Rida Ijaz
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .