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Comparative Effect of Training on Postpartum Depression

Primary Purpose

Postnatal Depression, Self Efficacy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Resistance training
Flexibility training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression focused on measuring Strength training, Functional status, Self efficacy

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jinnah HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance training

Flexibility training

Arm Description

Group A will receive resistance training. Twice per week for 8 weeks. Total 16 sessions will given.

Group B will receive flexibility training. Twice per week for 8 weeks. Total 16 sessions will given.

Outcomes

Primary Outcome Measures

Exercise self efficacy
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)
Epidemiological studies Depression scale
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
MAPP-QOL ( Maternal Postpartum Quality Life Questionnaire)
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
June 6, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05891717
Brief Title
Comparative Effect of Training on Postpartum Depression
Official Title
Comparative Effect of Flexibility and Resistance Training on Self-efficacy, Symptoms and Maternal Quality of Life in Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
July 13, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression, Self Efficacy
Keywords
Strength training, Functional status, Self efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Group A will receive resistance training. Twice per week for 8 weeks. Total 16 sessions will given.
Arm Title
Flexibility training
Arm Type
Active Comparator
Arm Description
Group B will receive flexibility training. Twice per week for 8 weeks. Total 16 sessions will given.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
Twice per week for 8 weeks. Total 16 sessions will given.
Intervention Type
Other
Intervention Name(s)
Flexibility training
Intervention Description
Twice per week for 8 weeks. Total 16 sessions will given.
Primary Outcome Measure Information:
Title
Exercise self efficacy
Description
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)
Time Frame
8 weeks
Title
Epidemiological studies Depression scale
Description
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
Time Frame
8 weeks
Title
MAPP-QOL ( Maternal Postpartum Quality Life Questionnaire)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postpartum Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phill
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phil
Phone
03248495979
Email
s.arshad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Aqsa Zahid, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18586183
Citation
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.
Results Reference
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PubMed Identifier
29162087
Citation
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.
Results Reference
background
PubMed Identifier
31343601
Citation
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.
Results Reference
background
PubMed Identifier
35045374
Citation
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.
Results Reference
background
PubMed Identifier
29094655
Citation
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.
Results Reference
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Comparative Effect of Training on Postpartum Depression

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