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CompletedNCT03261687Updated Aug 25, 2017

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

An interventional study of water based exercise and land based exercise in Pregnancy Related and Pelvic Girdle Pain, sponsored by University of Bradford. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by University of Bradford · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy Related
  • Pelvic Girdle Pain

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Keywords

  • pregnancy
  • pelvic girdle pain
  • hydrotherapy
  • quality of life
  • physical therapy
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherwater based exercise
  • Otherland based exercise
  • Behavioraladvice

    general advice given to all subjects

05

What researchers measure

Primary outcomes

  1. Pelvic Girdle Pain Questionnaire (PGPQ)

    A score change of 7 was set as a clinically significant difference

    Time frame: 4 weeks (pre and post intervention)

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    score change of 1.5 was set as clinically significant

    Time frame: 4 weeks (pre and post intervention)

  2. Patient Specific Functional Score (PSFS)

    score change of 1 was set as clinically significant

    Time frame: 4 weeks (pre and post intervention)

  3. Active Straight Leg Raise (ASLR).

    score change of 1 was set as clinically significant

    Time frame: 4 weeks (pre and post intervention)

06

Study locations

1 site
  • St George's Hospital,
    London, SW17 0QT, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03261687
Lead sponsor
University of Bradford
Collaborators
St George's University Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
May 27, 2016
Primary completion
Dec 31, 2016
Completion
Jan 31, 2017
Last update
Aug 25, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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