Clinical trial NCT05144269: Telerehabilitation in Postpartum Women
Official title: Investigation of the Effects of Multimodal Exercise-Based Telerehabilitation on Psychosocial Factors in Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Women
Telerehabilitation
Keywords: Postpartum
Depression
Physical activity
Pilates
Telerehabilitasyon
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Edinburgh Postpartum Depression Scale
timeFrame: 2 months
measure: Kaiser Physical Activity Questionnaire
timeFrame: 2 months
measure: Short Symptom Inventory
timeFrame: 2 months
Secondary outcomes:
measure: World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF)
timeFrame: 2 months
measure: Fatigue Severity Scale
timeFrame: 2 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 2 months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Clinical Research Ethics Commitee
Study officials:
affiliation: Akdeniz University
name: Sebahat Yaprak Cetin, Asst Prof
role: PRINCIPAL_INVESTIGATOR
References: