Postpartum Exercise and Return to Fitness: Optimise Readiness for Military Mums (PERFORM)

NCT04332757 | Unknown

• 2 other identifiers: 349408ASC/BA/00665
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this research is to investigate the effectiveness of a personalised physical training programme in returning servicewomen to fitness following childbirth. The idea behind the program is to target core and pelvic floor muscles, along with whole body strength and endurance to help servicewomen return to work safely and in a physically fit condition. The study will monitor the response to training using the following measures: urogynaecological measures (e.g., pelvic floor strength, prolapse, urinary incontinence), military specific fitness tests, musculoskeletal health (e.g., muscle and bone mass \& function) and mental health and wellbeing.

Conditions

Postpartum Period

Keywords

Performance; Servicewomen; Musculoskeletal; Well-Being

Outcome Measures

Primary Outcomes (1)

• Physical Performance Change Between 12 and 24 Weeks Postpartum

  Physical performance will be measured at weeks 12 and 24 using elements of the Soldier Strength and Conditioning review , which the servicewomen need to complete as part of their return to service following maternity leave. These tests include a vertical jump, mid-thigh pull, seated medicine ball throw and a 2 km run to best effort.

  Physical performance will be measured at weeks 12 and 24 postpartum.

Secondary Outcomes (14)

• Pelvic Organ Prolapse- Quantification System Change in Scores Between 6, 12 and 24 Weeks Postpartum

  : Pelvic Organ Prolapse- Quantification will be measured at weeks 6, 12 and 24 postpartum.

• Pelvic Floor Strength Change in Scores Between 6,12 and 24 Weeks Postpartum

  Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 postpartum.

• Musculoskeletal Physiotherapy Assessment Change Between 6,12 and 24 Weeks Postpartum

  : Musculoskeletal physiotherapy assessment will be measured at weeks 6, 12 and 24 postpartum.

• Pelvic Floor Distress Inventory Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum

  Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 postpartum.

• International Consultation on Incontinence Questionnaire - Vaginal Symptoms, Change in Scores Between 6, 12 and 24 Weeks Postpartum

  International consultation on incontinence questionnaire - vaginal symptoms will be measured at weeks 6, 12 and 24 postpartum.

Study Arms (2)

Training Intervention

EXPERIMENTAL

18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation.

Other: Training intervention.

Usual care control

NO INTERVENTION

Usual care acting as a control group.

Interventions

Training intervention. OTHER

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.

Training Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serving, pregnant (third trimester) or 0 to 6 weeks postpartum UK MOD Servicewomen.
• ≥ 18 years old.
• Free from any condition or injury that may affect the individual's ability to perform exercise (health screen).
• Passed fit to exercise by their GP at their routine 6-week postnatal check-up
• Passed fit to participate by a specialist women's health physiotherapist using study specific assessment criteria.
• Consent to be pregnancy tested before scans at 6 and 24 weeks postpartum.

You may not qualify if:

• \< 18 years old
• 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.
• Injured or suffering from another condition that can affect the individual's ability to perform exercise.
• Not passed fit to exercise by their GP at their routine 6-week postnatal check \[using standard fitness assessment criteria\].
• Not passed fit to participate following the women's clinical health assessment \[using study specific assessment criteria\].
• 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.

Sponsors & Collaborators

• Nottingham Trent University: lead
• University of Nottingham: collaborator
• Robert Gordon University: collaborator
• University of Stirling: collaborator
• Ministry of Defence, United Kingdom: collaborator
• Clare Pacey Physiotherapy Limited: collaborator

Study Sites (11)

Aldershot Centre for Health,

Aldershot, Hampshire,, GU11 1AY, United Kingdom

RECRUITING

Keogh Barracks

Aldershot, Hampshire, GU12 5RQ, United Kingdom

RECRUITING

Station Medical Centre

Hook, Hampshire, RG29 1QT, United Kingdom

RECRUITING

Middle Wallop Medical Centre,

Stockbridge, Hampshire, SO20 8DY, United Kingdom

RECRUITING

MRS Royal Military Academy

Camberley, Surrey,, GU15 4PQ, United Kingdom

RECRUITING

Minley Medical Centre

Blackwater, Surrey, Gu17 9LP, United Kingdom

RECRUITING

The Princess Royal Barracks

Deepcut, Surrey, GU16 6SQ, United Kingdom

RECRUITING

Elizabeth Barracks

Pirbright, Surrey, GU24 oDT, United Kingdom

RECRUITING

Larkhill Medical Centre

Salisbury, Wiltshire, SP4 8QY, United Kingdom

RECRUITING

Bulford Medical Centre

Salisbury, Wiltshire, SP4 9AD, United Kingdom

RECRUITING

Queen Elizabeth Memorial Health Centre

Tidworth, Wiltshire, SP9 7EA, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 35648463 DERIVED

Study Officials

• Craig Sale, PhD

  Nottingham Trent University

  PRINCIPAL INVESTIGATOR

• Kirsty Elliott-Sale, PhD

  Nottingham Trent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig Sale, PhD

CONTACT

+44(0)115 848 3505; craig.sale@ntu.ac.uk

Kirsty Elliott-Sale, PhD

CONTACT

+44(0)115 848 6338; kirsty.elliottsale@ntu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Physiology, Director of the Sport, Health and Performance Enhancement Research Centre

Model Details: An independent group design with participants at one site receiving usual care/no formal intervention (acting as a control group \[CON\]) and participants at a second site receiving usual care and additionally completing an 18-week phased physical development (rehabilitation and training) programme between weeks 6 and 24 postpartum (acting as the intervention group \[INT\]).

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 3, 2020
• Study Start: July 4, 2019
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (11)