NCT03261687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

August 23, 2017

Last Update Submit

August 24, 2017

Conditions

Keywords

pregnancypelvic girdle painhydrotherapyquality of lifephysical therapy

Outcome Measures

Primary Outcomes (1)

  • Pelvic Girdle Pain Questionnaire (PGPQ)

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

    4 weeks (pre and post intervention)

Secondary Outcomes (3)

  • Visual Analogue Scale (VAS)

    4 weeks (pre and post intervention)

  • Patient Specific Functional Score (PSFS)

    4 weeks (pre and post intervention)

  • Active Straight Leg Raise (ASLR).

    4 weeks (pre and post intervention)

Study Arms (2)

Water Exercise + advice

EXPERIMENTAL

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 exerciseBehavioral: advice

Land Exercise + advice

EXPERIMENTAL

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 exerciseBehavioral: advice

Interventions

Water Exercise + advice
Land Exercise + advice
adviceBEHAVIORAL

general advice given to all subjects

Land Exercise + adviceWater Exercise + advice

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St George's Hospital,

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Counseling

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a randomised controlled feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

May 27, 2016

Primary Completion

December 31, 2016

Study Completion

January 31, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations