Effects of Antenatal Exercises in Primagravida

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946408
• Other study ID #: REC/01546
• Status: Completed
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 21, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Khyber Teaching Hospital	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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