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NCT Number: NCT05946408

Effects of Antenatal Exercises in Primagravida

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.

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Key information

Conditions

Pregnancy Related Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised antenatal exercises

Other

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

Other

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.

Primary outcomes

  1. Low back pain

    Time frame: 12th Week

    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.

  2. The Roland Morris Low Back Pain and Disability Questionnaire

    Time frame: 12th Week

    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.

  3. Beck depression inventory

    Time frame: 12th week

    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

Secondary outcomes

  1. Multidimensional Fatigue Inventory

    Time frame: 12th week

    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.

  2. Fear of Childbirth Questionnaire

    Time frame: 12th week

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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