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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03261687
Other study ID # IRAS 198588
Secondary ID
Status Completed
Phase N/A
First received August 23, 2017
Last updated August 24, 2017
Start date May 27, 2016
Est. completion date January 31, 2017

Study information

Verified date August 2017
Source University of Bradford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.


Description:

This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme. Twenty-three participants with diagnosed PGP, recruited at St George's Hospital London, were randomised into two groups (water or land exercise). Each group received, four, once-weekly exercise sessions on land or water. Exercise effects on PGP were measured using a variety of outcome measures. Outcomes were assessed at baseline and post four weeks exercise.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 31, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

Participants were over eighteen years old, over twelve weeks pregnant and able to speak English.

Exclusion Criteria:

Participants were excluded from the study if they had uncontrolled blood pressure, placenta praevia, pre-eclampsia, obstetric cholestatsis, uncontrolled asthma, unstable respiratory or cardiac conditions, had open skin wounds or MRSA

Study Design


Related Conditions & MeSH terms


Intervention

Other:
water based exercise

land based exercise

Behavioral:
advice
general advice given to all subjects

Locations

Country Name City State
United Kingdom St George's Hospital, London

Sponsors (2)

Lead Sponsor Collaborator
University of Bradford St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pelvic Girdle Pain Questionnaire (PGPQ) A score change of 7 was set as a clinically significant difference 4 weeks (pre and post intervention)
Secondary Visual Analogue Scale (VAS) score change of 1.5 was set as clinically significant 4 weeks (pre and post intervention)
Secondary Patient Specific Functional Score (PSFS) score change of 1 was set as clinically significant 4 weeks (pre and post intervention)
Secondary Active Straight Leg Raise (ASLR). score change of 1 was set as clinically significant 4 weeks (pre and post intervention)
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