NCT07566715

Brief Summary

Vitamin D and calcium levels are negatively affected during postpartum period, making postnatal woman more vulnerable to health issues and consequently lowering her quality of life. Twelve-weeks of Pilates training have improved serum 25-hydroxy vitamin D levels and changed anthropometry in inactive overweight women. It is well-known globally that aerobic exercise is low to moderate-intensity physical activity.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet 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 Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 25, 2026

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vitamin D serum level

    High-performance liquid chromatography (Shimadzu, Japan) was used to assess 25(OH)D serum levels before and after the study program in both groups, using 25-OH vitamin D ELISA. Kits (Life Sciences Inc. USA). Values of 25(OH)D \< 20 ng/ml are considered deficient, values ranged 21 to 29 ng/ml are considered insufficient, and 30 ng/ml is considered ideal

    At baseline, and Immediately post-intervention

Secondary Outcomes (1)

  • Ionized calcium serum level

    At baseline, and Immediately post-intervention

Study Arms (2)

Experimental Group A (Pilates exercises group)

EXPERIMENTAL

Experimental Group A (Pilates exercises group) will be thirty postnatal women will perform Pilates exercises for 12 weeks, 3 sessions per week for 60 minutes

Other: Exercise

Experimental Group B(Aerobic exercises group)

EXPERIMENTAL

Experimental Group B(Aerobic exercises group) will be thirty postnatal women will perform aerobic exercises for 12 weeks, 3 sessions per week for 60 minutes

Other: Exercise

Interventions

Pilates exercises program will include twelve movements: Bridging, Roll Up, Pilates Hundred, One Leg Circle (both ways), Single Straight Leg Stretch, Double Leg Stretch, Spine Stretch Forward Single Leg Kick, Side Kick up and down, Side Kick circles, Curling.

Experimental Group A (Pilates exercises group)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostnatal women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages were ranged from 18-40 years old.
  • Their body mass index (BMI) was ranged from 25-35 kg/ m².
  • They were postnatal period by 6-12 weeks.
  • They were primipara or multipara.
  • They were healthy postpartum women.

You may not qualify if:

  • High risk pregnant history.
  • Sever postpartum complications.
  • Cardiovascular diseases i.e., utilizing pace maker.
  • Skeletal deformity.
  • Participation at any other exercise training program during this study.
  • Malignant conditions.
  • History of acute infection
  • Neurological problem; epileptic fits…etc.
  • Mental problem to prevent evaluation and cooperation.
  • Renal, liver or endocrinal disorders.
  • Pulmonary disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AlZahraa University Hospital

Cairo, Al Zahraa University Hospital, 11731, Egypt

Location

AlZahraa University Hospital

Cairo, Al Zahraa University Hospital, 11731, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mohamed A Awad, Professor

    Cairo University

    STUDY DIRECTOR
  • AbdelHamid A AttalAllah, Professor

    AlZahraaUniversity

    STUDY CHAIR

Central Study Contacts

Ahmed A Tolba, M.Sc.

CONTACT

Afaf M Botla, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Each participant will have one identification number that will be used to assign participants into two equal groups in number (n=30), sequentially numbered index cards will be secured in opaque envelopes. The researcher will open the sealed envelope, then will allocate the participants according to their groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, clinical randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecture of Physical Therapy

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 5, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations