Back to resultsThe Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
Primary Purpose
Pregnancy Related, Pelvic Girdle Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
water based exercise
land based exercise
advice
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related focused on measuring pregnancy, pelvic girdle pain, hydrotherapy, quality of life, physical therapy
Eligibility 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
Sites / Locations
- St George's Hospital,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Water Exercise + advice
Land Exercise + advice
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pelvic Girdle Pain Questionnaire (PGPQ)
A score change of 7 was set as a clinically significant difference
Secondary Outcome Measures
Visual Analogue Scale (VAS)
score change of 1.5 was set as clinically significant
Patient Specific Functional Score (PSFS)
score change of 1 was set as clinically significant
Active Straight Leg Raise (ASLR).
score change of 1 was set as clinically significant
Full Information
NCT ID
NCT03261687
First Posted
August 23, 2017
Last Updated
August 24, 2017
Sponsor
University of Bradford
Collaborators
St George's University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03261687
Brief Title
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bradford
Collaborators
St George's University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Pelvic Girdle Pain
Keywords
pregnancy, pelvic girdle pain, hydrotherapy, quality of life, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomised controlled feasibility study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water Exercise + advice
Arm Type
Experimental
Arm Description
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.
Arm Title
Land Exercise + advice
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
water based exercise
Intervention Type
Other
Intervention Name(s)
land based exercise
Intervention Type
Behavioral
Intervention Name(s)
advice
Intervention Description
general advice given to all subjects
Primary Outcome Measure Information:
Title
Pelvic Girdle Pain Questionnaire (PGPQ)
Description
A score change of 7 was set as a clinically significant difference
Time Frame
4 weeks (pre and post intervention)
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
score change of 1.5 was set as clinically significant
Time Frame
4 weeks (pre and post intervention)
Title
Patient Specific Functional Score (PSFS)
Description
score change of 1 was set as clinically significant
Time Frame
4 weeks (pre and post intervention)
Title
Active Straight Leg Raise (ASLR).
Description
score change of 1 was set as clinically significant
Time Frame
4 weeks (pre and post intervention)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
St George's Hospital,
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
We'll reach out to this number within 24 hrs