Clinical trial NCT04332757: Postpartum Exercise and Return to Fitness: Optimise Readiness for Military Mums (PERFORM)
Official title: The Efficacy of a Post-Partum Physical Development Programme on Occupational Physical Performance and Musculoskeletal Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Period
Keywords: Performance
Servicewomen
Musculoskeletal
Well-Being
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Robert Gordon University
name: University of Stirling
name: Ministry of Defence, United Kingdom
name: Clare Pacey Physiotherapy Limited
First posted: 2020-04-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 \[INT\]).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In an independent groups study design, the aim was to investigate the efficacy of a postpartum physical development programme on core reconnection (i.e., pelvic floor function, core strength/stability and urogynaecological measures), occupational physical performance, musculoskeletal health, and psychological health/wellbeing in servicewomen. Given that policy guidance is urgently needed regarding the safe return of servicewomen to functional occupational fitness, the aim of our proposed research is to inform the appropriate physical preparation of servicewomen in the postpartum period.

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.

Eligibility criteria: Inclusion Criteria:

1. Serving, pregnant (third trimester) or 0 to 6 weeks postpartum UK MOD Servicewomen.
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:

1. \< 18 years old
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.

Primary outcomes:
measure: Physical Performance Change Between 12 and 24 Weeks Postpartum
timeFrame: Physical performance will be measured at weeks 12 and 24 postpartum.
Secondary outcomes:
measure: Pelvic Organ Prolapse- Quantification System Change in Scores Between 6, 12 and 24 Weeks Postpartum
timeFrame: : Pelvic Organ Prolapse- Quantification will be measured at weeks 6, 12 and 24 postpartum.
measure: Pelvic Floor Strength Change in Scores Between 6,12 and 24 Weeks Postpartum
timeFrame: Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 postpartum.
measure: Musculoskeletal Physiotherapy Assessment Change Between 6,12 and 24 Weeks Postpartum
timeFrame: : Musculoskeletal physiotherapy assessment will be measured at weeks 6, 12 and 24 postpartum.
measure: Pelvic Floor Distress Inventory Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum
timeFrame: Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 postpartum.
measure: International Consultation on Incontinence Questionnaire - Vaginal Symptoms, Change in Scores Between 6, 12 and 24 Weeks Postpartum
timeFrame: International consultation on incontinence questionnaire - vaginal symptoms will be measured at weeks 6, 12 and 24 postpartum.
measure: World Health Organisation Quality of Life Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum
timeFrame: The World Health Organisation Quality of Life Questionnaire will be measured at weeks 6, 12 and 24 postpartum.
measure: Edinburgh Post Natal Depression Scale, Change in Scores Between 6, 12 and 24 Weeks Postpartum
timeFrame: The Edinburgh Post Natal Depression Scale will be measured at weeks 6, 12 and 24 postpartum.
measure: Body Composition Changes Between 6 and 24 Weeks Postpartum
timeFrame: Body composition will be measured at weeks 6 and 24 postpartum.
measure: Bone Health Changes Between 6 and 24 Weeks Postpartum
timeFrame: Bone health will be measured at weeks 6 and 24 postpartum.
measure: Tendon Properties Changes Between 6, 12 and 24 Weeks Postpartum
timeFrame: Tendon properties will be measured at weeks 6, 12 and 24 postpartum.
measure: Muscle Architecture Changes Between 6, 12 and 24 Weeks Postpartum
timeFrame: Muscle architecture will be measured at weeks 6, 12 and 24 postpartum.
measure: Muscle Protein and Collagen Turnover Changes Between 12 and 18 Weeks Postpartum
timeFrame: : Muscle protein and collagen turnover will be measured at weeks 12 and 18 postpartum.
measure: Muscle Mass Changes Between 6, 12, 18 and 24 Weeks Postpartum
timeFrame: Muscle mass will be measured at weeks 6, 12,18 and 24 postpartum.
measure: Muscle Breakdown Changes Between 12 and 18 Weeks Postpartum
timeFrame: Muscle breakdown will be measured at weeks 12 and 18 postpartum
Other outcomes:
Locations:
city: Aldershot,
country: United Kingdom
facility: Aldershot Centre for Health,
state: Hampshire,
city: Aldershot
country: United Kingdom
facility: Keogh Barracks
state: Hampshire
city: Hook
country: United Kingdom
facility: Station Medical Centre
state: Hampshire
city: Stockbridge,
country: United Kingdom
facility: Middle Wallop Medical Centre,
state: Hampshire
city: Camberley,
country: United Kingdom
facility: MRS Royal Military Academy
state: Surrey,
city: Blackwater
country: United Kingdom
facility: Minley Medical Centre
state: Surrey
city: Deepcut
country: United Kingdom
facility: The Princess Royal Barracks
state: Surrey
city: Pirbright
country: United Kingdom
facility: Elizabeth Barracks
state: Surrey
city: Salisbury,
country: United Kingdom
facility: Larkhill Medical Centre
state: Wiltshire
city: Salisbury
country: United Kingdom
facility: Bulford Medical Centre
state: Wiltshire
city: Tidworth
country: United Kingdom
facility: Queen Elizabeth Memorial Health Centre
state: Wiltshire
Study officials:
affiliation: Nottingham Trent University
name: Craig Sale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham Trent University
name: Kirsty Elliott-Sale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.