NCT05931588

Brief Summary

The aim of the study is to determine the effect of Pilates exercises on postpartum fatigue, maternal functioning and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

January 4, 2023

Last Update Submit

June 27, 2023

Conditions

Keywords

Pilatesmaternal fatiguematernal functioning

Outcome Measures

Primary Outcomes (1)

  • postnatal maternal fatigue

    The Postnatal Accumulated Fatigue Scale (PAFS) (Tsuchiya et al., 2016) was once used to investigate maternal fatigue and included questions masking the three areas of physical, emotional and cognitive fatigue. The PAFS involves thirteen objects with every coded on a three-point response ranking the place zero = rarely, 1 = sometimes and three = often. Total rankings vary from zero to 39 with greater ratings indicating a greater stage of fatigue. The PAFS consists of questions overlaying three areas of physical, emotional, and cognitive fatigue and has top validity and interior consistency.

    8 Week

Secondary Outcomes (2)

  • barkin indexmaternal functioning

    8 Week

  • postnatal quality of life

    8 Week

Other Outcomes (2)

  • generalized anxiety scale

    8 Week

  • • Edinburgh postnatal depression scale (EPDS)

    8 Week

Study Arms (2)

Pilates exercises, streching and breathing

EXPERIMENTAL

the intervention Pilates exercises, streching and breathing exercises is administered under supervision

Other: Pilates excercises, streching and breathingOther: stretching and breathing

streching and breathing

EXPERIMENTAL

home based exercise program which is streching and breathing.

Other: stretching and breathing

Interventions

international group receive Pilates exercises, stretching and breathing two times a week (30 min per session) perform 3 to 5 reps of Pilates exercises under supervision

Pilates exercises, streching and breathing

control group guided with stretching and breathing home based program both group till 8 week both groups

Pilates exercises, streching and breathingstreching and breathing

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Multiparous females
  • Age 18 to 45 years
  • Females with vaginal delivery
  • Two weeks after Spontaneous Vaginal Delivery
  • Fatigue score of \>11 on Fatigue Assessment scale

You may not qualify if:

  • Postpartum depression score greater or equal to 10 , based on the Edinburgh Postnatal Depression scale (EPDS)
  • Postpartum anemia
  • Generalized Anxiety Disorders
  • Chronic illnesses (Diabetes /hypothyroidism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imrana nasir family clinic

Rawalpindi, Punjab Province, 25000, Pakistan

Location

MeSH Terms

Interventions

Respiration

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Summra Andleeb, MS(OMPT)

    riphah internation university

    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

January 4, 2023

First Posted

July 5, 2023

Study Start

December 2, 2022

Primary Completion

May 5, 2023

Study Completion

May 25, 2023

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations