NCT04813341

Brief Summary

The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

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

September 18, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

March 22, 2021

Last Update Submit

September 17, 2021

Conditions

Keywords

DepressionFatiguelow intensity Aerobic trainingMat-Pilates

Outcome Measures

Primary Outcomes (2)

  • Multidimensional Fatigue Inventory

    The MFI-20 is a self-report of 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue. By limiting the length of questionnaire, developers hoped to accommodate those individuals who might find larger measures especially tiring in obtaining multiple facets of fatigue. The internal consistency of MFI-20 is ranging from .53 to .93.

    6 weeks

  • Edinburgh Postnatal Depression Scale

    EPDS developed for screening postpartum women in outpatient, home-visiting settings or at 6-8-week postpartum examination. It consists of 10 questions for postnatal period which reliably identifies women at risk of developing depression. The sensitivity and specificity of EPDS is 70-85%.

    6 weeks

Study Arms (2)

Pilates training

EXPERIMENTAL

Bridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles

Other: Pilates training

Aerobic Training

ACTIVE COMPARATOR

WALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week SITTING EERCISES: Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times BALANCE EXERCISES: Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week. Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week.

Other: Aerobic Training

Interventions

Bridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles. The participant will be instructed to perform 3-5 repetitions of these movements at the start, and to add two more repetitions for each movement every week until the end of the intervention.

Pilates training

WALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week SITTING EERCISES: Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times BALANCE EXERCISES: Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week. Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week.

Aerobic Training

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Vaginal delivery
  • Singleton pregnancy

You may not qualify if:

  • Caesarean delivery
  • Vacuum-assisted delivery
  • Sexually Transmitted Diseases
  • Menopause females
  • Any condition regarding Obstetrics \& Gynecology
  • Any physical or mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anmol Hospital Phalia

Jhelum, Punjab Province, 50430, Pakistan

Location

MeSH Terms

Conditions

Depression, PostpartumDepressionFatigue

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Anam Aftab, Phd*

    Riphah college of rehabilitation and allied health sciences - Rawalpindi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

September 18, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations