NCT05397808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

May 26, 2022

Last Update Submit

November 14, 2022

Conditions

Keywords

Pilates exercisesdepressionsleep quality

Outcome Measures

Primary Outcomes (10)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Assessment will be conducted immediately after the intervention

Study Arms (2)

pilates group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

The group that received pilates training.

pilates group

The group who received breathing and relaxation exercises with a home program.

control group

Eligibility Criteria

Age25 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Altındağ, Ankara, 06050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Puerperal DisordersDepressionSleep Initiation and Maintenance Disorders

Interventions

Exercise Movement TechniquesRespiration

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • HALİL I BULGUROGLU

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Using a computer program, the investigators randomly placed individuals who completed the initial assessment into the pilates group or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 26, 2022

First Posted

May 31, 2022

Study Start

May 23, 2022

Primary Completion

September 18, 2022

Study Completion

September 25, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations