Telerehabilitation in Postpartum Women

NCT ID: NCT05144269

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-06-22

Brief Summary

Postpartum is a transitional period in which physical, social and emotional changes take place in the women. Especially the difficulty of psychological and physiological changes can be associated with deterioration in the women's health. Exercise support programs given to postpartum women have been shown to contribute to physical, mental and social well-being. Statistically significant improvements were found in depression and anxiety symptoms, energy and fatigue parameters, and general health regarding the effects of exercise on mental health in pregnant and postpartum women. The recommendation of the American Association of Obstetricians and Gynecologists (ACOG) is that women start physical activity as soon as they are medically or obstetrically safe. It is stated that they can be included in the exercise programs as soon as possible if it is a normal delivery, and after the 6th week, except for certain exercises if it is a cesarean section. Literature mentioned that exercise studies with postpartum women are insufficient. These mostly focused on the postpartum period and women who had a cesarean section were excluded. In their studies comparing the clinical and virtual environment; Although there is no statistical difference, there are studies showing that it is superior. To the best knowledge, there were no studies on postpartum telerehabilitation. Literature with a multidimensional approach in line with the recommendations of the guidelines were also limited.

Detailed Description

This study is a randomized controlled trial aiming to examine the improvement in psychosocial status and physical activity in postpartum women after 8 weeks of multimodal exercise-based telerehabilitation. Two groups will be formed, namely the intervention group and the training group.

Multimodal exercise-based telerehabilitation will be applied to the intervention group by an experienced physiotherapist in 45-minute sessions, 2 days a week, for 8 weeks; Postpartum and exercise related training will be given and they will be asked to walk gradually increasing aerobic exercises. All interventions are common except for the control group telerehabilitation. Women will be evaluated before and after the study. 'Edinburgh Postpartum Depression Scale (EPDS)', 'Fatigue Severity Scale (FSS)', 'Pittsburgh Sleep Quality Index (PUKI), 'World Health Organization Lifestyle' for depression, fatigue, sleep, quality of life, physical activity and mental health in evaluations. World Health Organization Quality of Life Scale (WHOQOL-BREF)', 'Kaiser Physical Activity Questionnaire (KFAA)', 'Short Symptom Inventory' will be used.

Conditions

Postpartum Women; Telerehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multimodal exercises group

Multimodal exercise-based telerehabilitation will be implemented with video conference method. For telerehabilitation, a program including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises was created. Sessions consist of 45 minutes. Telerehabilitation will take place 2 days a week for 8 weeks.

Group Type: EXPERIMENTAL

Multimodal exercises

Intervention Type: OTHER

Telehabilitation including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises

Education group

30 minutes of training will be given about postpartum and exercises. As exercise, only aerobic walking exercise, which can be started for 15 minutes a day and 3 days a week according to the guide, gradually increasing, up to 30 minutes and up to 4 days a week will be applied. There will also be a warm-up and a cool-down period before the walking exercise. \*Exercise intensity is determined in the 12-14 score range according to the Borg Scale, and how to apply it will be explained.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multimodal exercises

Telehabilitation including pilates, breathing, progressive relaxation training, posture and pelvic floor strengthening exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Postpartum between 6-12 weeks
• giving birth to a healthy baby
• Having technological devices that can be connected online via video conferencing,
• women who can use technological devices to connect

Exclusion Criteria

• Multiple pregnancy,
• Having other diseases that will affect their functions,
• Having a problem related to the musculoskeletal system (such as abdominal hernia) that will prevent exercise,
• having neurological, rheumatic disease
• having chronic pain
• Diastasis recti distance greater than 2 cm,
• Women whose babies were hospitalized during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Sebahat Yaprak Cetin, PT

Asst, Prof, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebahat Yaprak Cetin, Asst Prof

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

Akdeniz University Clinical Research Ethics Commitee

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-400

Identifier Type: -

Identifier Source: org_study_id