Effects of Antenatal Exercises in Primagravida

Effects Of Supervised Antenatal Exercises On Low Back Pain And Depression In Primigravida

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Supervised antenatal exercises; Other: Antenatal Education

Detailed Description

Females usually tend to avoid physical activity during pregnancy. Concept of antenatal exercises and its effects on low back pain or antenatal depression is yet not common amongst pregnant females in Pakistan. Low back pain and antenatal depression are common in pregnancy. These can have an impact on both their own health and the health of their unborn child. Understanding the benefits of antenatal exercises will encourage pregnant females to engage in regular physical activity. The results of this study will help physical therapists to implement effective exercise interventions for this population.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Khyber Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised Antenatal Exercises; Supervised antenatal exercises twice a week an antenatal education	Other: Supervised antenatal exercises; 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.
Active Comparator: Antenatal Education; Antenatal education only	Other: Antenatal Education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Fatigue Inventory	Changes from baseline fatigue will be assessed using Multidimensional Fatigue Inventory. The MFI is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Items are scored on a scale of 1 to 5. For the total score, a higher score represent greater fatigue.	12th week
Fear of Childbirth Questionnaire	Changes from baseline The Fear of Childbirth Questionnaire (FCQ) this is 20 item questionnaires for women who are pregnant. Items are scored on a scale of 1 to 5. A higher score indicates greater fear	12th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sarah Ehsan, PP-DPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; Pregnancy Related; antenatal depression
• Other Study ID Numbers: REC/01546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No