Pregnancy RelatedNCT03261687
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
A study testing water based exercise, land based exercise and advice in people with Pregnancy Related and Pelvic Girdle Pain, run by University of Bradford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pelvic Girdle Pain
- What is being tested?
- water based exercise, land based exercise and advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2016to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were over eighteen years old, over twelve weeks pregnant and able to speak English.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Pregnancy Related, Pelvic Girdle Pain
- Being tested
- water based exercise, land based exercise, advice
- Keywords
- pregnancy, pelvic girdle pain, hydrotherapy, quality of life, physical therapy
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water based exerciseOther
land based exerciseOther
adviceBehavioural
general advice given to all subjects
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: water based exercise; Behavioral: 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. Receives: Other: land based exercise; Behavioral: advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Girdle Pain Questionnaire (PGPQ)
A score change of 7 was set as a clinically significant difference
Measured: 4 weeks (pre and post intervention)
Secondary outcomes (3)
Visual Analogue Scale (VAS)
score change of 1.5 was set as clinically significant
Measured: 4 weeks (pre and post intervention)
Patient Specific Functional Score (PSFS)
score change of 1 was set as clinically significant
Measured: 4 weeks (pre and post intervention)
Active Straight Leg Raise (ASLR).
score change of 1 was set as clinically significant
Measured: 4 weeks (pre and post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start27 May 2016
- Primary completion31 Dec 2016
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomised controlled feasibility study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bradford
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261687
- Sponsor's protocol ID
- IRAS 198588
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03261687
- Acronym / sponsor ID
- IRAS 198588
- Conditions
- Pregnancy Related, Pelvic Girdle Pain
- Keywords
- pregnancy, pelvic girdle pain, hydrotherapy, quality of life, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of BradfordUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust
- Study start
- 27 May 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomised controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Water Exercise + advice | Experimental | Other: water based exercise, Behavioral: adviceEach 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. |
| Land Exercise + advice | Experimental | Other: land based exercise, Behavioral: adviceEach 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants were over eighteen years old, over twelve weeks pregnant and able to speak English.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water based exercise | Other | Water Exercise + advice |
| land based exercise | Other | Land Exercise + advice |
| advicegeneral advice given to all subjects | Behavioural | Land Exercise + advice, Water Exercise + advice |
Primary outcome
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
3 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 4 weeks (pre and post intervention)
Patient Specific Functional Score (PSFS)
Time frame: 4 weeks (pre and post intervention)
Active Straight Leg Raise (ASLR).
Time frame: 4 weeks (pre and post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water based exercise, land based exercise and advice in people with Pregnancy Related and Pelvic Girdle Pain, run by University of Bradford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Girdle Pain Questionnaire (PGPQ) (time frame: 4 weeks (pre and post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.