Clinical trial NCT05397808: Effects of Pilates Exercises on Postpartum
Official title: The Effects of Pilates Exercises on the Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Disorder
Keywords: Pilates exercises
depression
sleep quality
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 58
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using a computer program, the investigators randomly placed individuals who completed the initial assessment into the pilates group or control group.
Primary purpose: TREATMENT

Brief summary: The postpartum period for the family is the period of adjustment in which a new order is established due to adding a new member to the family. For the mother, this period is a transitional period in which she has to adapt to her baby, postpartum disorders, the new order in the family, and changes in body image. Inactivity is common in today's world; increases the risk of various problems in new mothers. These problems negatively affect women's depression, functional level, sleep quality, and quality of life in the postpartum period. The Pilates method, developed by Joseph Pilates under the name of "Contrology," is the most well-known exercise method in the world for babies and mothers among today's exercise programs since it is an exercise method in which all systems, spirit, and body are integrated and coordinated, considering the whole physiological process.

This study aims to understand how depression, loss of functionality, sleep quality, functional levels, and quality of life levels of women who do pilates exercises with a physiotherapist are affected in the postpartum period.

Detailed description: The investigators conducted the study at Ankara Medipol University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation. This study was conducted by the principles set out in the Declaration of Helsinki. Fifty postpartum women aged 25-38 will be included in the study.

* Procedures The investigators assessed the participants by an experienced physiotherapist, who was blind to the randomization, at the start of the study and after the 8-week training. The group on which they depended was not disclosed to the participants until the end of the baseline evaluation. The investigators used a computer program for randomization and randomly placed individuals who completed the initial assessment into the pilates group (PG) or control group (CG). The investigators performed the Pilates exercises under the supervision of a certified physiotherapist with ten years of experience. The investigators asked the individuals not to inform the evaluator of their involvement in the training during the last evaluation. Before the study, the investigators explained the purpose and content of the survey to the participants and obtained written informed consent from all pregnant women to participate in the study.

Pilates training was done by an Australian Pilates and Physiotherapy Institute certified and experienced Ph.D. Physiotherapist Halil Ibrahim Bulguroglu lasted eight weeks, two days a week for one h. The investigators divided the individuals in the Pilates exercise group into two smaller groups of 12 or 13 to verify whether they correctly did the exercises. In this study, the investigators organized a program to include 15 min of warm-up, 30 min of Pilates exercises, and 15 min of cooling and stretching exercises. The exercises were done in 10 repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during postpartum was used in training. During the Pilates exercises, investigators described the activities with different visual simulation techniques, and exercises were done together with Pilates breathing. The intensity of the exercises was increased by using different positions and elastic bands. The resistance was increased by starting with the red Therabant and switching to the blue band after two weeks. If the new resistance amount was challenging for the patient, the exercises were continued with the same color band for one more week. Stretching exercises and posture exercises were used during the cooling period. The subjects in the online pilates group were informed about side effects such as shortness of breath, dizziness, headache, muscle pain, and weakness. They were asked to stop exercising when there were any side effects.

-Statistical analysis The investigators will perform statistical analysis using SPSS software, version 21 (SPSS Inc. Chicago, IL, USA). The normal distribution of variables will be determined using histograms, probability plots, and a Shapiro-Wilk test. Because of an abnormal distribution, median and interquartile range (IQR) were used for descriptive statistics. Numerical variables showing normal distribution were shown as mean±standard deviation. The investigators will use a Mann-Whitney U test to compare baseline and change values between groups. The investigators will use Wilcoxon Test to compare baseline values within the group and values after eight weeks. The significance level will be set at p \< 0.05 for all analyses.

Eligibility criteria: Inclusion Criteria:

* Vaginal birth
* First birth
* At least six weeks postpartum
* Absence of any anomaly in the mother or baby after birth
* Being between the ages of 25-38
* Having a body mass index \<30

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.
* Participating in other exercises or physiotherapy programs during the past 6 months.
* Cesarean delivery

Primary outcomes:
measure: Depression- Baseline
timeFrame: Baseline
measure: Depression- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Oswestry Disability Index- Baseline
timeFrame: Baseline
measure: Oswestry Disability Index- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Postpartum Sleep Quality Scale- Baseline
timeFrame: Baseline
measure: Postpartum Sleep Quality Scale- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: The Inventory of Functional Status After Childbirth- Baseline
timeFrame: Baseline
measure: The Inventory of Functional Status After Childbirth- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Maternal Postpartum Quality of Life Questionnaire- Baseline
timeFrame: Baseline
measure: Maternal Postpartum Quality of Life Questionnaire- Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Ankara Medipol University
state: Ankara
Study officials:
affiliation: Ankara Medipol University
name: HALİL I BULGUROGLU
role: PRINCIPAL_INVESTIGATOR
References: