Clinical trial NCT06382428: The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period
Official title: Comparison of the Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method and Supervised in the Postpartum Period on Pelvic Floor Muscle Function, Pelvic Floor Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Postpartum Disorder
Quality of Life
Mothers
Keywords: Pelvic floor muscle training
Postpartum
Telerehabilitation
Quality of Life
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
Collaborators: name: Biruni University
name: Yeditepe University
name: Fenerbahce University
First posted: 2024-04-24
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum).


Eligibility criteria: Inclusion Criteria:

* Being a woman between 18-35 years old
* Between the 6th and 8th weeks postpartum
* Native Turkish
* Having the appropriate technological infrastructure to participate in an exercise session via the Internet (for the TR-PFMT group)

Exclusion Criteria:

* Number of births \>2
* The week of pregnancy \<32
* Having a history of 3rd and 4th-degree perineal tears
* Cesarean birth
* Inability to contract the pelvic floor muscle (pelvic floor muscle strength ≤2 according to the Modified Oxford Scale)
* The electromyography values of the abdominal muscles or hip adductors during contraction of the pelvic floor muscles are more than 10 microvolts
* The presence of neurological, orthopedic, psychiatric, hematological or cardiovascular disease that would prevent PFMT as questioned by the gynecologist
* Body mass index ≥ 25 kg/m²
* The presence of active urinary tract or vaginal infection in the last week

Primary outcomes:
measure: Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Distress Inventory-20 to measure the urinary symptoms
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life
timeFrame: pre-intervention; immediately after the intervention
measure: Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life
timeFrame: pre-intervention; immediately after the intervention
measure: Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles
timeFrame: pre-intervention; immediately after the intervention
measure: Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles
timeFrame: pre-intervention; immediately after the intervention
measure: Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles
timeFrame: pre-intervention; immediately after the intervention
measure: Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles
timeFrame: pre-intervention; immediately after the intervention
measure: Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles
timeFrame: pre-intervention; immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Fenerbahçe University
name: Arzu Razak Özdinçler, PT, PhD, Prof.
role: STUDY_DIRECTOR
affiliation: İzmir Tınaztepe University
name: Damla Korkmaz Dayıcan, PT, PhD (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeditepe University
name: Burçin Özyürek, PT, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References: