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The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261687
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
St George's University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University of Bradford

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Pelvic Girdle Pain Other: water based exercise Other: land based exercise Behavioral: advice Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomised controlled feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain : a Randomised Controlled Feasibility Study.
Actual Study Start Date : May 27, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Water Exercise + advice
Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise). Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.
Other: water based exercise
Behavioral: advice
general advice given to all subjects

Experimental: Land Exercise + advice
Each group undertook four, once weekly exercise sessions (including a warm up, cool down, relaxation, pelvic control and stability exercise). Both programmes focused on similar exercise and muscle groups, but due to the aquatic medium programmes were unable to be exactly matched.
Other: land based exercise
Behavioral: advice
general advice given to all subjects




Primary Outcome Measures :
  1. Pelvic Girdle Pain Questionnaire (PGPQ) [ Time Frame: 4 weeks (pre and post intervention) ]
    A score change of 7 was set as a clinically significant difference


Secondary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 4 weeks (pre and post intervention) ]
    score change of 1.5 was set as clinically significant

  2. Patient Specific Functional Score (PSFS) [ Time Frame: 4 weeks (pre and post intervention) ]
    score change of 1 was set as clinically significant

  3. Active Straight Leg Raise (ASLR). [ Time Frame: 4 weeks (pre and post intervention) ]
    score change of 1 was set as clinically significant



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261687


Locations
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United Kingdom
St George's Hospital,
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
University of Bradford
St George's University Hospitals NHS Foundation Trust

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Responsible Party: University of Bradford
ClinicalTrials.gov Identifier: NCT03261687    
Other Study ID Numbers: IRAS 198588
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bradford:
pregnancy
pelvic girdle pain
hydrotherapy
quality of life
physical therapy
Additional relevant MeSH terms:
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Pelvic Girdle Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Pelvic Pain