NCT05946408

Brief Summary

The goal of this Randomized control trial is to determine the effects of antenatal exercises on low back pain in Primagravida. The main questions it aims to answer are whether supervised antenatal exercises have an effect on low back pain and depression in primagravida.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 5, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

July 7, 2023

Last Update Submit

December 26, 2023

Conditions

Pregnancy Related

Keywords

Pregnancy Relatedantenatal depressionlow back pain

Outcome Measures

Primary Outcomes (3)

  • Low back pain

    Changes from baseline low back pain will be assessed on Numeric pain rating scale. The scale ranges from 0 for no pain to 10 for worse pain.

    12th Week

  • The Roland Morris Low Back Pain and Disability Questionnaire

    Changes from baseline low back pain related disability will be assessed using Roland Morris low back pain and disability questionnaire. It is a self-report questionnaire consisting of 24 questions that are scored on a dichotomous scale (yes/no). The total score ranges from 0 to 24, with higher scores indicating greater disability.

    12th Week

  • Beck depression inventory

    Changes from baseline antenatal depression will be assessed using Beck depression inventory. A total score of 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms

    12th week

Secondary Outcomes (2)

  • Multidimensional Fatigue Inventory

    12th week

  • Fear of Childbirth Questionnaire

    12th week

Study Arms (2)

Supervised Antenatal Exercises

EXPERIMENTAL

Supervised antenatal exercises twice a week an antenatal education

Other: Supervised antenatal exercises

Antenatal Education

ACTIVE COMPARATOR

Antenatal education only

Other: Antenatal Education

Interventions

Supervised antenatal exercisesOTHER

Supervised antenatal exercises along with education twice a week. Protocol consists of warm up (10 min), Aerobic training (20 mins, 60-75% of max. HR), Strength training (25 minutes), followed by a cool down of 15 minutes. The Interventions to be provided for a period of 12 weeks.

Supervised Antenatal Exercises
Antenatal EducationOTHER

Antenatal education at 12th week of pregnancy. Which consists of education on Posture in pregnancy, Role of pelvic floor muscles, Labor and breathing and relaxation techniques.

Antenatal Education

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primagravida
  • Single pregnancy
  • Diagnosed for risk of Prenatal depression on EDPS \>10
  • Pregnancy related Low back pain score of 3 to 8 on NPRS for at least 2 weeks.
  • Females in 2nd Trimester of pregnancy

You may not qualify if:

  • Any present or previous pelvic floor dysfunctions diagnosed by health professionals.
  • Any physical disability causing inability to perform physical exercises.
  • Any contraindications to physical activity according to ACOG
  • Pelvic girdle pain (Anterior: Pubic symphysis, Posterior: SI joint Pain, Gluteal Pain, Piriformis syndrome).
  • Rheumatoid disorders.
  • Low back pain with radiation
  • Not engaged in regular exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sarah Ehsan, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 14, 2023

Study Start

July 5, 2023

Primary Completion

December 1, 2023

Study Completion

December 21, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)