Telerehabilitation in Postpartum Women

NCT05144269 | Completed

• 1 other identifier: 2021-400
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Women; Telerehabilitation

Keywords

Postpartum; Depression; Physical activity; Pilates; Telerehabilitasyon

Outcome Measures

Primary Outcomes (3)

• Edinburgh Postpartum Depression Scale

  The Edinburgh Postpartum Depression Scale, developed by Cox and Holden, is used to determine the risk of depression in the postpartum period and to measure the change in level and severity. The scale is a self-assessment scale consisting of 10 questions in 4-point Likert type. The scores obtained from the scale vary between 0-30. The cut-off point is 13 and those who score 13 and above are considered to have depression risk/suspicion.

  2 months

• Kaiser Physical Activity Questionnaire

  It was adapted from the Baecke Physical Activity Questionnaire to measure physical activity in women. In the scale, both how often the activities are done and how much time is spent on that activity are questioned. The survey consists of 38 questions in total. The questions in the survey are grouped under four main headings: "housework/care", "occupational", "active life", "sports and exercise". There are 11, 8, 4 and 15 questions in these categories, respectively. The questions are scored from 1 to 5. The scores of each category are averaged. It is then multiplied by the frequency, duration and MET value and summed up on all activities. The MET values of 3.5, 5 and 7, respectively, were used to represent the average MET values of activity in each intensity category. Categorical, total activity and weighted total activity scores are calculated.

  2 months

• Short Symptom Inventory

  It is a 53-item multidimensional symptom screening scale developed by Derogatis (1992). It consists of 9 subscales and 3 global indexes. These; It includes somatization, obsessive-compulsive symptom, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid thought, and psychoticism dimensions. The scoring of the items is in the liker type between 0 and 4. The total score range varies between "0-212". It is evaluated that the higher the score, the higher the frequency of mental symptoms. Subscale scores are obtained by dividing the sum of the scores given to the items forming each subscale by the number of items.

  2 months

Secondary Outcomes (3)

• World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF)

  2 months

• Fatigue Severity Scale

  2 months

• Pittsburgh Sleep Quality Index

  2 months

Study Arms (2)

Multimodal exercises group

EXPERIMENTAL

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.

Other: Multimodal exercises

Education group

NO INTERVENTION

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.

Interventions

Multimodal exercises OTHER

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

Multimodal exercises group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women in the postpartum period who have just given birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Clinical Research Ethics Commitee

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sebahat Yaprak Cetin, Asst Prof

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst, Prof, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: November 30, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)