NCT05891717

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

April 18, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Strength trainingFunctional statusSelf efficacy

Outcome Measures

Primary Outcomes (3)

  • 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)

    8 weeks

  • 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

    8 weeks

  • 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.

    8 weeks

Study Arms (2)

Resistance training

EXPERIMENTAL

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

Other: Resistance training

Flexibility training

ACTIVE COMPARATOR

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

Other: Flexibility training

Interventions

Twice per week for 8 weeks. Total 16 sessions will given.

Resistance training

Twice per week for 8 weeks. Total 16 sessions will given.

Flexibility training

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum Female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 to 40
  • weeks to 8 months postpartum females
  • primiparous or multiparous postnatal wome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 18586183BACKGROUND
  • 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.

    PMID: 29162087BACKGROUND
  • 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.

    PMID: 31343601BACKGROUND
  • 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). 2022 Feb;92:105570. doi: 10.1016/j.clinbiomech.2021.105570. Epub 2022 Jan 3.

    PMID: 35045374BACKGROUND
  • 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.

    PMID: 29094655BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sabiha Arshad, M.Phill

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

June 7, 2023

Study Start

November 20, 2022

Primary Completion

July 13, 2023

Study Completion

August 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations