The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period

NCT ID: NCT06382428

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2024-01-30

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).

Conditions

Pelvic Floor Disorders; Postpartum Disorder; Quality of Life; Mothers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TR-PFMT group

In the TR-PFMT group, the PFMT program was carried out via a synchronous online platform (Skype™ program). Participants were asked to install Skype™ software on their personal computers or phones and create a personal account. In the first evaluation session, participants were taught how to use the hardware and software. Additionally, they were asked to place their cameras at an average distance of 1-1.5 meters so that their entire body could be seen. At the beginning of each session, they were informed that their information was kept confidential and their audio and video images would not be shared with another person.

Group Type: EXPERIMENTAL

Pelvic floor muscle training

Intervention Type: OTHER

The PFMT program was carried out for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program consisted of education, diaphragm breathing exercises, pelvic mobility exercises, exercises to strengthen and stretch the pelvic floor muscles and other muscles related to the pelvis. In addition, the participants were expected to do the same exercises at home 2 days a week.

S-PFMT group

In the S-PFMT group, the PFMT program was conducted as a face-to-face session in groups of 4 people.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type: OTHER

The PFMT program was carried out for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program consisted of education, diaphragm breathing exercises, pelvic mobility exercises, exercises to strengthen and stretch the pelvic floor muscles and other muscles related to the pelvis. In addition, the participants were expected to do the same exercises at home 2 days a week.

Interventions

Pelvic floor muscle training

The PFMT program was carried out for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program consisted of education, diaphragm breathing exercises, pelvic mobility exercises, exercises to strengthen and stretch the pelvic floor muscles and other muscles related to the pelvis. In addition, the participants were expected to do the same exercises at home 2 days a week.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biruni University

OTHER

Sponsor Role: collaborator

Yeditepe University

OTHER

Sponsor Role: collaborator

Fenerbahce University

OTHER

Sponsor Role: collaborator

Izmir Tinaztepe University

OTHER

Sponsor Role: lead

Responsible Party

Damla Korkmaz Dayican

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu Razak Özdinçler, PT, PhD, Prof.

Role: STUDY_DIRECTOR

Fenerbahçe University

Damla Korkmaz Dayıcan, PT, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

İzmir Tınaztepe University

Burçin Özyürek, PT, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

Yeditepe University

Locations

Yeditepe University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

T-DAYICAN-002

Identifier Type: -

Identifier Source: org_study_id