NCT06303258

Brief Summary

Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable low-back-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

March 4, 2024

Last Update Submit

July 15, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale (VAS)

    It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients

    Changes from Baseline to 2nd week

  • Visual Analogue Scale (VAS)

    It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients

    Changes from 2nd week to 4th week

  • Pregnant women's quality of life questionnaire (QOL-GRAV)

    Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all \[0\] to totally \[4\]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.

    Changes from Baseline to 2nd week

  • Pregnant women's quality of life questionnaire (QOL-GRAV)

    Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all \[0\] to totally \[4\]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.

    Changes from 2nd week to 4th week

Study Arms (3)

Core Stabalization Exercises Group

EXPERIMENTAL

This Group will receive core stability exercises 3 sessions per week for 4 weeks and basic antenatal education.

Other: Core Stabalization Exercises

Generalized Exercise Group

EXPERIMENTAL

This Group will receive generalized supervised antenatal exercises that are covered in three phases and basic antenatal education. There will be 3 sessions per week for 10weeks conducted for generalized antenatal exercises including Aerobics, Endurance and Pelvic Floor Muscle Training.

Other: Generalized Antenatal Exercises

Control Group

NO INTERVENTION

Basic Antenatal Education for Lumbopelvic Pain Prevention

Interventions

Low Intensity Warm Up Exercises Core Stabilization Exercises Cool Down Stretching Exercises

Core Stabalization Exercises Group

Low Intensity WarmUp Exercise Aerobic Training Endurance Training Pelvic Floor Muscle Training Cool Down Stretching Exercises

Generalized Exercise Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • nd Trimester of Pregnancy
  • Multigravida
  • Patients having Lumbopelvic pain
  • Working women and housewives

You may not qualify if:

  • Hx of Metabolic Disease
  • Hx of Pelvic Fracture and Surgery
  • Radiculopathy
  • Participants with absolute contraindications for the exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehsil Headquarter Hospital Raiwind

Lahore, Punjab Province, 55150, Pakistan

Location

Related Publications (4)

  • Sklempe Kokic I, Ivanisevic M, Uremovic M, Kokic T, Pisot R, Simunic B. Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial. J Rehabil Med. 2017 Mar 6;49(3):251-257. doi: 10.2340/16501977-2196.

    PMID: 28233012BACKGROUND
  • Stuge B. Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review. Braz J Phys Ther. 2019 Mar-Apr;23(2):181-186. doi: 10.1016/j.bjpt.2018.11.006. Epub 2018 Nov 17.

    PMID: 30471967BACKGROUND
  • Varela-Esquivias A, Diaz-Martinez L, Avendano-Badillo D. [Efficacy of lumbopelvic stabilization exercises in patients with lumbalgia]. Acta Ortop Mex. 2020 Jan-Feb;34(1):10-15. Spanish.

    PMID: 33230993BACKGROUND
  • Leonard JH, Paungmali A, Sitilertpisan P, Pirunsan U, Uthaikhup S. Changes in Transversus Abdominis Muscle Thickness after Lumbo-Pelvic Core Stabilization Training among Chronic Low Back Pain Individuals. Clin Ter. 2015;166(5):e312-6. doi: 10.7417/T.2015.1884.

    PMID: 26550815BACKGROUND

MeSH Terms

Conditions

Low Back PainPelvic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Huma Riaz, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

March 4, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations