NCT07055737

Brief Summary

This study is a single-blinded randomized controlled trial designed to compare the effectiveness of aerobic exercises and Barre exercises in improving psychological well-being among postpartum females. A total of 44 participants aged between 18-35 years, within 6-12 weeks postpartum, were randomly assigned to two groups: Group A received aerobic exercises while Group B received Barre training.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 28, 2025

Last Update Submit

June 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Edinburgh Postnatal Depression Scal

    EPDS (Edinburgh Postnatal Depression Scale): 10 items; scored 0-30; higher scores indicate greater depression risk. Score \>12 considered clinically significant.

    6 Month

  • Generalized Anxiety Disorder Scale

    GAD-7 (Generalized Anxiety Disorder Scale): 7 items; scored 0-21; higher scores indicate greater anxiety. Score ≥10 suggests moderate/severe anxiety.

    6 Months

Study Arms (2)

supervised aerobic activities

EXPERIMENTAL
Combination Product: supervised aerobic activities

Barre group performed light warm-up

EXPERIMENTAL
Combination Product: Barre group performed light warm-up

Interventions

Participants performed supervised aerobic activities including warm-up (15 min), brisk walking, jogging, or cycling (30 min), squats on exercise ball (10 min), and cool down (5 min). Sessions were conducted three times a week

supervised aerobic activities

Barre group performed light warm-up (15 min), lower abdominal crunches, leg raises, wall push-ups, and planks (3 sets each), followed by cool-down stretches (5 min). Sessions were conducted three times a week.

Barre group performed light warm-up

Eligibility Criteria

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

You may qualify if:

  • Females aged 18-35 years
  • Postpartum duration of 6-12 weeks
  • Experiencing symptoms of depression, anxiety, or mood disturbance

You may not qualify if:

  • History of neonatal death
  • More than 3 miscarriages
  • Diagnosed psychiatric conditions
  • Pre-eclampsia, gestational diabetes, or cardiovascular illness
  • Currently on psychiatric medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University

Lahore, Punjab Province, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 9, 2025

Study Start

March 3, 2025

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

July 9, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations