ClinicalTrials.gg
CompletedNCT04043533Updated Aug 2, 2019

The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women

An interventional study of Exercises in Depression, Postpartum, sponsored by Didem Kucukkelepce. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by Didem Kucukkelepce · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Sep 2017, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
Female
01

Study summary

Aim: This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery.

Methods: This randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. The participating women were administered the Edinburgh Postpartum Depression Scale.

Read the detailed description

Postpartum depression is characterized by irritability, guilt, burnout, anxiety, sleep disorders, and somatic symptoms that could have negative effects on the mother, baby, and family.

In a meta-analysis study including 219 prevalence studies from 56 countries that investigated different phases of postpartum using various data collection tools, Hahn-Holbrook et al. (2018) found the depression prevalence at the global level as 17.7% (Hahn-Holbrook, 2018). In Turkey, 23.8% of women in the postpartum period were reported to be suffering from postpartum depression, which underlines the need for health professionals to be concerned about the health of the women in the postpartum period.

Exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss caused by lactation, and less stress incontinence. Studies have generally indicated the importance of regular exercise in the postpartum period. Studies have generally indicated the importance of regular exercise in the postpartum period.

02

Conditions studied

  • Depression, Postpartum
03

In context

Depression, Postpartum

536 studies on the registry are indexed under Depression, Postpartum; 126 are open to participants now.

This study's enrollment of 80 is below the median of 105 across 430 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

This is the only study on the registry with Didem Kucukkelepce as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. must be score of 13 and over in the Edinburgh Postpartum Depression Scale (EPDS),
  2. must being between 19 and 40 years old,
  3. must had a spontaneous vaginal delivery between the 38th and 42nd weeks of pregnancy,
  4. must had a healthy newborn baby with 2500 gr and over

Exclusion criteria

Exclusion Criteria:

  1. postpartum obstetric complications
  2. psychiatric disease history before or during pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Exercises Group

    Behavioral: Exercises

  • No intervention
    Control Group

Interventions

  • BehavioralExercises

    The women in the experimental group were given information about the benefits of exercises done in the postpartum period, the time to start these exercises, and the exercises to be conducted in three different phases (mild, medium, severe). The first physical exercise practice was done in the FHC together. In line with the recommendations by ACOG (2015), the women were told to do mild and medium level exercises in the first two weeks, at least five days in a week and at least half an hour daily (ACOG, 2015). They were also told that they should do medium and severe level exercises in the following two weeks. They were asked to mark on the form what time, how long, and at what level they did the exercises every day. The education booklet that included this information and the visuals of the exercises were given to the women in the experimental group. In addition, the women were called once a week in order to check whether the training was applied.

06

What researchers measure

Primary outcomes

  1. Effect of exercise

    questionnaire and scale, Edinburgh Postpartum Depression Scale (EPDS) The screening scale, developed by Cox et al. (1987), aimed to identify depression risk in women in the postpartum period. It's a self-report scale that is composed of 10 items aiming to measure the individual's psychological state within the past 7 days. Each item is rated on a four-point Likert scale between 0 and 3 ("Yes, all the time", "Yes, most of the time", "No, not very often", and "No, not at all". Total score ranges between 0 and 30. Higher scores indicate the severity of depression. Aydin et al. (2004) performed the reliability and validity of the scale and identified the cut-off point for Turkish women as 12.5

    Time frame: 4 week

07

Study locations

1 site
  • Didem Şimşek Küçükkelepçe
    Adi̇yaman, 02100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Feb 2018, 5 months.

Of 241 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's 5 months is below that.

Counting every sponsor, half of 247 studies reached it within 23 months; a quarter within 11 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2019
First posted
Aug 2, 2019
StartActual
Sep 1, 2017
Primary completionActual
Feb 15, 2018
CompletionActual
Jun 15, 2018
Last update
Aug 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04043533
Lead sponsor
Didem Kucukkelepce
Responsible party
Didem Kucukkelepce (Didem Kucukkelepce, Adiyaman University Research Hospital) — Sponsor-investigator
First posted
Aug 2, 2019
Start date
Sep 1, 2017
Primary completion
Feb 15, 2018
Completion
Jun 15, 2018
Last update
Aug 2, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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