An interventional study of Pilates Training and breathing and relaxation exercises in Postpartum Disorder, sponsored by Ankara Medipol University. Completed at 1 site in Turkey. Open to female participants aged 25 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Ankara Medipol University · Not applicable, Interventional, and Treatment
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.
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.
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.
40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.
This study's enrollment of 58 is below the median of 81 across 32 interventional studies indexed under Puerperal Disorders.
Browse Puerperal Disorders studies →Ankara Medipol University is the lead sponsor of 56 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pilates training will be held for eight weeks, two days a week for 1 hour. The investigators divided the individuals in the pilates exercise group into groups of 12 or 13 to verify whether they did the exercises correctly. A program including 15 minutes of warm-up, 30 minutes of Pilates exercises, and 15 minutes of cooling and stretching exercises was arranged for the pilates group. The activities were performed in ten repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during postpartum will be used in the training.
Other: Pilates Training
The control group was given breathing and relaxation exercises, which they would do two days a week for eight weeks, in the form of a home program. Diaphragmatic breathing and respiratory control were given as breathing exercises.
Other: breathing and relaxation exercises
The group that received pilates training.
The group who received breathing and relaxation exercises with a home program.
Depression- Baseline
Edinburgh Postpartum Depression Scale (EPDS) is a self-report scale consisting of 10 items, in a 4-point Likert format. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point for EPDS is 13 points. Accordingly, 13 points and above indicate the risk of depression.
Time frame: Baseline
Depression- Post intervention
Edinburgh Postpartum Depression Scale (EPDS) is a self-report scale consisting of 10 items, in a 4-point Likert format. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point for EPDS is 13 points. Accordingly, 13 points and above indicate the risk of depression.
Time frame: Assessment will be conducted immediately after the intervention
Oswestry Disability Index- Baseline
The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, degree of pain change, travel, and social life. When calculating the total score, it is multiplied by two and expressed as a percentage. The maximum score is "100," and the minimum score is "0". As the total score increases, the level of disability also increases.
Time frame: Baseline
Oswestry Disability Index- Post intervention
The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, degree of pain change, travel, and social life. When calculating the total score, it is multiplied by two and expressed as a percentage. The maximum score is "100," and the minimum score is "0". As the total score increases, the level of disability also increases.
Time frame: Assessment will be conducted immediately after the intervention
Postpartum Sleep Quality Scale- Baseline
The PSQS is scored using a 5-point Likert scale ranging from 0 to 4 (0 = never,1= rarely,2= sometimes,3= often, and 4 = always). The items with an asterisk are scored in reverse order. Possible scores for the PSQS range from 0 to 56, with no cutoff point designated and higher scores indicating poor sleep quality.
Time frame: Baseline
Postpartum Sleep Quality Scale- Post intervention
The PSQS is scored using a 5-point Likert scale ranging from 0 to 4 (0 = never,1= rarely,2= sometimes,3= often, and 4 = always). The items with an asterisk are scored in reverse order. Possible scores for the PSQS range from 0 to 56, with no cutoff point designated and higher scores indicating poor sleep quality.
Time frame: Assessment will be conducted immediately after the intervention
The Inventory of Functional Status After Childbirth- Baseline
The IFSAC consists of five subscales, including five dimensions of functional status and 36 four-point Likert-type questions to determine postpartum recovery. Each question of the IFSAC has been evaluated over four points (from one to four). A high score (close to four) indicates high functional status.
Time frame: Baseline
The Inventory of Functional Status After Childbirth- Post intervention
The IFSAC consists of five subscales, including five dimensions of functional status and 36 four-point Likert-type questions to determine postpartum recovery. Each question of the IFSAC has been evaluated over four points (from one to four). A high score (close to four) indicates high functional status.
Time frame: Assessment will be conducted immediately after the intervention
Maternal Postpartum Quality of Life Questionnaire- Baseline
Postpartum quality of life is a scale that is evaluated according to the perception of the mother and consists of five sub-dimensions and a total of 40 items. The scores obtained after the procedure are summed up and divided by the number of scale questions (40 items), and a fixed value (15) is added to the number obtained from the section to avoid negative results, and the result is found. Thus, the Quality of Life Scores is in the range of 0-30. The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores indicate a lower postpartum quality of life.
Time frame: Baseline
Maternal Postpartum Quality of Life Questionnaire- Post intervention
Postpartum quality of life is a scale that is evaluated according to the perception of the mother and consists of five sub-dimensions and a total of 40 items. The scores obtained after the procedure are summed up and divided by the number of scale questions (40 items), and a fixed value (15) is added to the number obtained from the section to avoid negative results, and the result is found. Thus, the Quality of Life Scores is in the range of 0-30. The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores indicate a lower postpartum quality of life.
Time frame: Assessment will be conducted immediately after the intervention
Ran from May 2022 to primary completion in Sep 2022, 3 months.
Of 20 interventional studies with no phase under Puerperal Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 3 months is below that.
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Ankara Medipol University