Postpartum Exercise and Return to Fitness: Optimise Readiness for Military Mums (PERFORM)
NCT ID: NCT04332757
Last Updated: 2021-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-07-04
2022-09-20
Brief Summary
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Detailed Description
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Participants at selected sites around the Royal Military Academy at Sandhurst will receive usual care/no formal intervention (acting as a control group \[CON\]) and participants at different sites around Army Headquarters will receive usual care and additionally complete an 18-week phased physical development (rehabilitation and training) programme between weeks 6 and 24 postpartum (acting as the intervention group \[INT\]). If recruitment numbers are low at the main sites (Aldershot and Tidworth) we will seek to recruit participants to INT from Bulford, Middle Wallop, Larkhill and Marlborough Lines for INT and to CON from Sandhurst, Odiham, Pirbright, Keogh, Minley, Deepcut as well as locations outside of the named INT sites. The geographical separation of sites was deemed to be important for maintaining differences between intervention and control group activity.
The investigators have designed a phased 18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation. The rehabilitation element of the programme will specifically target pelvic floor function and core strength and stability (known collectively as Core Reconnection training) from weeks 6 to 24 postpartum, and the training element of the programme will contain resistance and high-intensity interval training (HIIT) from weeks 12 to 24 postpartum
The aim of this research is to investigate the effectiveness of a tailored rehabilitation and physical preparation programme for postpartum women on:
1. Occupational fitness performance;
2. Female health assessments (i.e., urinary incontinence, pelvic floor strength);
3. Musculoskeletal health;
4. Psychological health and wellbeing.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Training Intervention
18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation.
Training intervention.
The investigators have designed a phased 18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation. The rehabilitation element of the programme will specifically target pelvic floor function and core strength and stability (known collectively as Core Reconnection training) from weeks 6 to 24 postpartum, and the training element of the programme will contain resistance and high-intensity interval training (HIIT) from weeks 12 to 24 postpartum.
Usual care control
Usual care acting as a control group.
No interventions assigned to this group
Interventions
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Training intervention.
The investigators have designed a phased 18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation. The rehabilitation element of the programme will specifically target pelvic floor function and core strength and stability (known collectively as Core Reconnection training) from weeks 6 to 24 postpartum, and the training element of the programme will contain resistance and high-intensity interval training (HIIT) from weeks 12 to 24 postpartum.
Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 years old.
3. Free from any condition or injury that may affect the individual's ability to perform exercise (health screen).
4. Passed fit to exercise by their GP at their routine 6-week postnatal check-up
5. Passed fit to participate by a specialist women's health physiotherapist using study specific assessment criteria.
6. Consent to be pregnancy tested before scans at 6 and 24 weeks postpartum.
Exclusion Criteria
2. Diagnosed with post-natal depression or another mental health condition requiring specialist psychiatric secondary care. Additionally, any participant who is found to have, or develops over the course of the trial, severe post-natal depression or suicidal tendencies, will be referred back to their GP.
3. Injured or suffering from another condition that can affect the individual's ability to perform exercise.
4. Not passed fit to exercise by their GP at their routine 6-week postnatal check \[using standard fitness assessment criteria\].
5. Not passed fit to participate following the women's clinical health assessment \[using study specific assessment criteria\].
6. Women who report that they could be pregnant and / or have a positive pregnancy test before measurements at 6 and 24 weeks postpartum will not be scanned using DXA or HR-pQCT. They will cease to take any further part in the trial and will be advised to visit their GP.
18 Years
FEMALE
Yes
Sponsors
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University of Nottingham
OTHER
Robert Gordon University
OTHER
University of Stirling
OTHER
Ministry of Defence, United Kingdom
OTHER_GOV
Clare Pacey Physiotherapy Limited
UNKNOWN
Nottingham Trent University
OTHER
Responsible Party
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Craig Sale
Professor of Human Physiology, Director of the Sport, Health and Performance Enhancement Research Centre
Principal Investigators
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Craig Sale, PhD
Role: PRINCIPAL_INVESTIGATOR
Nottingham Trent University
Kirsty Elliott-Sale, PhD
Role: PRINCIPAL_INVESTIGATOR
Nottingham Trent University
Locations
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Aldershot Centre for Health,
Aldershot, Hampshire,, United Kingdom
Keogh Barracks
Aldershot, Hampshire, United Kingdom
Station Medical Centre
Hook, Hampshire, United Kingdom
Middle Wallop Medical Centre,
Stockbridge, Hampshire, United Kingdom
MRS Royal Military Academy
Camberley, Surrey,, United Kingdom
Minley Medical Centre
Blackwater, Surrey, United Kingdom
The Princess Royal Barracks
Deepcut, Surrey, United Kingdom
Elizabeth Barracks
Pirbright, Surrey, United Kingdom
Larkhill Medical Centre
Salisbury, Wiltshire, United Kingdom
Bulford Medical Centre
Salisbury, Wiltshire, United Kingdom
Queen Elizabeth Memorial Health Centre
Tidworth, Wiltshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Elliott-Sale KJ, Bostock EL, Jackson T, Wardle SL, O'Leary TJ, Greeves JP, Sale C. Investigating the Efficacy of an 18-Week Postpartum Rehabilitation and Physical Development Intervention on Occupational Physical Performance and Musculoskeletal Health in UK Servicewomen: Protocol for an Independent Group Study Design. JMIR Res Protoc. 2022 Jun 1;11(6):e32315. doi: 10.2196/32315.
Other Identifiers
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ASC/BA/00665
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
349408
Identifier Type: -
Identifier Source: org_study_id
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