- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05891717
Comparative Effect of Training on Postpartum Depression
Comparative Effect of Flexibility and Resistance Training on Self-efficacy, Symptoms and Maternal Quality of Life in Postpartum Depression
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness.
This study will be a randomized clinical trial. It divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. Data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. In this study Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) will be used as subjective measurements.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Postpartum depression typically begins within the first two to three days after delivery and may last for up to several weeks or months. Activity and mobility are an integral part of human life that is manifested in a special way in each period. Postpartum life has caused lack of movement, the risk factor of depression and difficulty in maternal life. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness. A logical approach to treatment, therefore, would be to improve postpartum life. Flexibility exercises are not just for gymnasts, but rather for everyone. Along with the better range of motion, it decreases risks of injuries, increases blood supply and nutrients to joints, reduces muscular tension and help to improve quality of life.
This study will be a randomized clinical trial. Subjects meeting the predetermined inclusion and exclusion criteria will divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. After informed consents were obtained, data will collect. After taking written consent from participants who meet the inclusion criteria, data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. Pre-treatment assessment and Post treatment reading will be done using Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) as subjective measurements. Recorded values will be analyzed for any change using SPSs version 25.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Jinnah Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20 to 40
- 6 weeks to 8 months postpartum females
- primiparous or multiparous postnatal wome
Exclusion Criteria:
- Family history of depression
- Hospitalization for a psychiatric disorder in the past 6 months; and currently receiving antidepressant medication or psychotherapy for depression.
- Pregnant women
- Women with psychiatric diagnoses other than depression
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance training
Group A will receive resistance training.
Twice per week for 8 weeks.
Total 16 sessions will given.
|
Twice per week for 8 weeks.
Total 16 sessions will given.
|
|
Active Comparator: Flexibility training
Group B will receive flexibility training.
Twice per week for 8 weeks.
Total 16 sessions will given.
|
Twice per week for 8 weeks.
Total 16 sessions will given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise self efficacy
Time Frame: 8 weeks
|
A 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults; specifically the ability to continue to exercise despite barriers.
The participant is asked about their confidence level, on a scale from 0 (not confident) to 10 (very confident)
|
8 weeks
|
|
Epidemiological studies Depression scale
Time Frame: 8 weeks
|
The Center for Epidemiologic Studies Depression Scale (CES-D) is a brief self-report questionnaire developed in 1977 by Laurie Radloff to measure depressive symptoms severity in the general population
|
8 weeks
|
|
MAPP-QOL ( Maternal Postpartum Quality Life Questionnaire)
Time Frame: 8 weeks
|
Maternal Postpartum Quality of Life (MAPP-QOL) questionnaire, which is a self-administered instrument that measures quality of life during the early postnatal period.
12 The MAPP-QOL is composed of five domains and demonstrates convergent validity with measures of life satisfaction and mood states.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.Phill, Riphah International University
Publications and helpful links
General Publications
- Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
- Posmontier B. Functional status outcomes in mothers with and without postpartum depression. J Midwifery Womens Health. 2008 Jul-Aug;53(4):310-8. doi: 10.1016/j.jmwh.2008.02.016.
- Papamarkou M, Sarafis P, Kaite CP, Malliarou M, Tsounis A, Niakas D. Investigation of the association between quality of life and depressive symptoms during postpartum period: a correlational study. BMC Womens Health. 2017 Nov 21;17(1):115. doi: 10.1186/s12905-017-0473-0.
- Hooker QL, Lanier VM, Roles K, van Dillen LR. Motor skill training versus strength and flexibility exercise in people with chronic low back pain: Preplanned analysis of effects on kinematics during a functional activity. Clin Biomech (Bristol, Avon). 2022 Feb;92:105570. doi: 10.1016/j.clinbiomech.2021.105570. Epub 2022 Jan 3.
- Mirghafourvand M, Bagherinia M. Relationship between maternal self-efficacy and functional status four months after delivery in Iranian primiparous women. J Psychosom Obstet Gynaecol. 2018 Dec;39(4):321-328. doi: 10.1080/0167482X.2017.1394290. Epub 2017 Nov 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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