Effects of Antenatal Exercises in Primagravida

NCT ID: NCT05946408

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pregnancy Related antenatal depression low back pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supervised Antenatal Exercises

Supervised antenatal exercises twice a week an antenatal education

Group Type EXPERIMENTAL

Supervised antenatal exercises

Intervention Type 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

Antenatal education only

Group Type ACTIVE_COMPARATOR

Antenatal Education

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sarah Ehsan, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Khyber Teaching Hospital

Peshawar, KPK, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/01546

Identifier Type: -

Identifier Source: org_study_id