NCT06704568

Brief Summary

This study aimed to investigate the positive effects of abdominal core exercises and deep breathing exercises on abdominal muscle strength, pulmonary function, fatigue, and quality of life in the early postnatal period (1-6 months).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

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

May 20, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

October 11, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

core stabilitationfatiguepospartumbreathing exercises

Outcome Measures

Primary Outcomes (1)

  • Static Trunk Endurance Test

    For endurance measurement,three core endurance tests were performed following the protocol of the TEMT. the trunk flexor endurance test and the bilateral side bridge tests. All movements were conducted after sufficient practice to eliminate any bias towards cognition, and the subjects aimed to maintain a static posture for as long as possible. The subjects sat with knees bent at 90° on the table for the trunk flexor endurance test, and their feet were held in place by a belt. Afterwards, they crossed their hands in front of their chests, leaned against the 60 degree trunk support, pulled the trunk support back 3 cm, and maintained this posture for as long as possible.The examination was stopped when the posture of lying on their side was lost or when their buttocks fell to the mat

    8 week

Secondary Outcomes (2)

  • quality of life test

    8 week

  • Pulmonary Function Test

    8 week

Study Arms (3)

core exercise and early pospartum

EXPERIMENTAL

Unlike the control group; core exercises for 20-30 minutes, 3 days a week for 8 weeks, and respiratory exercises combined with core exercises for the respiratory exercises group

Other: exercise

breathing exercise

EXPERIMENTAL

Slow and controlled breathing exercises will be performed starting with 5 seconds of inhalation and 5 seconds of exhalation twice a day for 10 minutes, 5 days a week for eight weeks, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhalation and 5-second exhalation cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breathing a few times. The respiratory exercises will be finished with relaxation exercises.

Other: exercise

control

EXPERIMENTAL

No application will be made to the control group.

Other: exercise

Interventions

Unlike the control group; core exercises for 20-30 minutes, 3 days a week for 8 weeks, and respiratory exercises combined with core exercises for the respiratory exercises group: Slow and controlled breathing exercises will be performed starting with 5 seconds of inhalation and 5 seconds of exhalation twice a day for 10 minutes, 5 days a week for eight weeks, with a 10-second diaphragmatic breathing cycle (6 breaths/minute). The finger counting method will be recommended so that participants can easily follow the 5-second inhalation and 5-second exhalation cycles. The exercises can be done sitting or lying down. The individuals will be taught the differences between the two by switching between normal and deep breathing a few times. The respiratory exercises will be finished with relaxation exercises.

breathing exercisecontrolcore exercise and early pospartum

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHaving given birth within the last 1-6 months
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having given birth within the last 1-6 months
  • Being between the ages of 18-45
  • Having a singleton pregnancy
  • Willingness to participate in the study
  • No history of physical or mental illness.

You may not qualify if:

  • Those with postpartum anemia
  • Those with postpartum respiratory tract infections
  • Those whose newborns were hospitalized for any reason
  • Those who gave birth to multiple babies
  • Those with a history of chronic back pain
  • Those with neurological symptoms
  • Those with cardiovascular and respiratory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haymana State Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Kim S, Yi D, Yim J. The Effect of Core Exercise Using Online Videoconferencing Platform and Offline-Based Intervention in Postpartum Woman with Diastasis Recti Abdominis. Int J Environ Res Public Health. 2022 Jun 8;19(12):7031. doi: 10.3390/ijerph19127031.

    PMID: 35742279BACKGROUND

MeSH Terms

Conditions

Overtraining SyndromeFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 1st group N=30 control group, 2nd group N=30 core exercise group, 3rd group N=30 breathing exercises group will be randomly divided into 3 groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of physiotherapy department of haymana vocational high school physiotherapy

Study Record Dates

First Submitted

October 11, 2024

First Posted

November 26, 2024

Study Start

May 20, 2024

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
6 mount

Locations