Postpartum PeriodPERFORMNCT04332757
Postpartum Exercise and Return to Fitness: Optimise Readiness for Military Mums (PERFORM)
A study testing Training intervention. in people with Postpartum Period, run by Nottingham Trent University at 11 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Training intervention.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 4 Jul 2019to 20 Sep 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- < 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites, 11 recruiting
- Recruiting
Aldershot Centre for Health,
Aldershot, Hampshire,, GU11 1AY
Elaine Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Keogh Barracks
Aldershot, Hampshire, GU12 5RQ
Elaine Walker, 01980 650640, elaine.walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Minley Medical Centre
Blackwater, Surrey, Gu17 9LP
Elaine Walker, 01980 650640, elaine.walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
MRS Royal Military Academy
Camberley, Surrey,, GU15 4PQ
Elaine Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
The Princess Royal Barracks
Deepcut, Surrey, GU16 6SQ
Elaine Walker, 01980 650640, elaine.walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Station Medical Centre
Hook, Hampshire, RG29 1QT
Elaine Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Elizabeth Barracks
Pirbright, Surrey, GU24 oDT
Elaine Walker, 01980 650640, elaine.walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Larkhill Medical Centre
Salisbury, Wiltshire, SP4 8QY
Elaine Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Bulford Medical Centre
Salisbury, Wiltshire, SP4 9AD
Elaine Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Middle Wallop Medical Centre,
Stockbridge, Hampshire, SO20 8DY
Elaine Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
- Recruiting
Queen Elizabeth Memorial Health Centre
Tidworth, Wiltshire, SP9 7EA
Elaine S Walker, 01980 650640, Elaine.Walker907@mod.gov.uk
Emma Bostock, PhD
About this study
Official title: The Efficacy of a Post-Partum Physical Development Programme on Occupational Physical Performance and Musculoskeletal Health
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.
Read the 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:
- Occupational fitness performance;
- Female health assessments (i.e., urinary incontinence, pelvic floor strength);
- Musculoskeletal health;
- Psychological health and wellbeing.
- Conditions
- Postpartum Period
- Being tested
- Training intervention.
- Keywords
- Performance, Servicewomen, Musculoskeletal, Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Training Intervention | Experimental | 18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation. Receives: Other: Training intervention. |
| Usual care control | No intervention | Usual care acting as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 will be measured by the research associate women's health physiotherapist at weeks 6, 12 and 24. Vaginal examination will assess for prolapse using the Pelvic Organ Prolapse Quantification system staging pelvic support from 0-4, 0 being no prolapse demonstrated and 4 demonstrating full procidentia.
Measured: : 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 strength will be measured by the research associate women's health physiotherapist at week 6, 12 and 24. Pelvic floor strength will be measured digitally using the modified oxford scale ranging from 0-5, 0 being no discernible contraction and 5 overcoming strong resistance. Over-activity and co-ordination of the pelvic floor muscle will be assessed by a simple yes/no answer following digital vaginal examination.
Measured: 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 measures will be assessed by the research associate women's health physiotherapist at weeks 6, 12 and 24. Posture, movement patterns, breathing will be objectively evaluated and commented on. The abdominal muscles (rectus diastasis) will be assessed by measuring the distance between the internal borders of the rectus abdominus muscle by placing the fingers vertically on the linea alba 4 cm above and below the umbilicus, during a curl up movement. Scoring is obtained through an approximation of centimetre width separation and the tone of the linea alba structure. The larger the score in centimetres the greater the separation of the rectus abdominus muscle.
Measured: : 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
The Pelvic Floor Distress Inventory will be completed at 6, 12 and 24 weeks by all participants. The Pelvic Floor Distress Inventory is scored ranging from 0-300, 0 being the least distress and 300 being the greatest distress.
Measured: 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
The International Consultation on Incontinence Questionnaire - Vaginal Symptoms will be completed at 6, 12 and 24 weeks by all participants. The International consultation on Incontinence Questionnaire - Vaginal Symptoms evaluates vaginal symptoms, associated sexual matters and impact on quality of life. Three scores are generated. Subscales range from 0-53 vaginal symptoms, 0-58 sexual matters and 0-10 overall impact on quality of life. 0 represents the least bothersome in each subscale. The subscales are not incorporated in an overall score.
Measured: International consultation on incontinence questionnaire - vaginal symptoms will be measured at weeks 6, 12 and 24 postpartum.
World Health Organisation Quality of Life Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum
The World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF) will be given to participants in paper. The WHOQOL-BREF provides an overall quality of life/wellbeing score and allows calculation of a score for each of the four sub-scales (physical health, psychological, social relationships and environment). The four domain scores are scaled in a positive direction (higher score equal higher quality of life). The mean score of items within each domain is used to calculate the domain score.
Measured: The World Health Organisation Quality of Life Questionnaire will be measured at weeks 6, 12 and 24 postpartum.
Edinburgh Post Natal Depression Scale, Change in Scores Between 6, 12 and 24 Weeks Postpartum
The Edinburgh Post Natal Depression Scale (EPDS) asks participants to answer questions by reflecting on the past 7 days. The questionnaire produces a total score of postnatal depression symptoms (range 0-30) with a score of 13 and above indicating likelihood of a depressive illness of varying severity
Measured: The Edinburgh Post Natal Depression Scale will be measured at weeks 6, 12 and 24 postpartum.
Body Composition Changes Between 6 and 24 Weeks Postpartum
Body composition (fat mass, fat-free mass and bone mineral density) will be measured at weeks 6 and 24 by a whole-body dual-energy x-ray absorptiometry (DXA) scan.
Measured: Body composition will be measured at weeks 6 and 24 postpartum.
Bone Health Changes Between 6 and 24 Weeks Postpartum
Bone microarchitecture will be determined at weeks 6 and 24 by a HRpQCT scan; two scans of the tibia (distal 4% and 30% site) will be performed on the non-dominant leg to assess training-induced changes in bone microarchitecture and density.
Measured: Bone health will be measured at weeks 6 and 24 postpartum.
Tendon Properties Changes Between 6, 12 and 24 Weeks Postpartum
Tendon stiffness and young's modulus will be measured using ultrasonography with a linear array probe. Patella tendon length and elongation will be calculated as the distance from the apex of the patellar and the shadow created by a fixed marker. Patella tendon stiffness will be calculated by dividing knee extensor torque by the estimated patella tendon moment arm. Knee extensor torque will be calculated as the sum of the measured knee extension torque and the antagonistic torque, estimated through the root mean square of the biceps femoris muscle electromyography signal. Force-elongation data will be fitted with to a second order polynomial curve to determine patella tendon stiffness. Tendon CSA will be assessed along the full resting length of the tendon on the axial plane through ultrasonography. Young's modulus will then be calculated as tendon stiffness multiplied by the ratio of tendon length over tendon cross-sectional area.
Measured: Tendon properties will be measured at weeks 6, 12 and 24 postpartum.
Muscle Architecture Changes Between 6, 12 and 24 Weeks Postpartum
Fascicle length of the vastus lateralis will be assessed at weeks 6, 12 and 24 by the acquisition and analysis of images taken using B-mode ultrasonography (MyLab Omega, Esaote, UK), with a linear array probe. Images will be obtained with the participant lying at rest in a supine position. Images will be taken at 50% of the length of the vastus lateralis and at the midsagittal line of the muscle. The transducer will be aligned to the fascicle plane to allow optimal capture of the fascicles.
Measured: Muscle architecture will be measured at weeks 6, 12 and 24 postpartum.
Muscle Protein and Collagen Turnover Changes Between 12 and 18 Weeks Postpartum
Muscle protein/collagen turnover will be measured from blood, saliva and skeletal muscle biopsy samples. Participants will provide a saliva sample before being given a drink of 'heavy' water (D2O); water that is enriched with a metabolic isotope tracer that can be used to evaluate the rate of protein and collagen turnover by determining the rate of tracer incorporation into muscle tissue. The muscle biopsy will be used to measure the incorporation of deuterated alanine into muscle tissue over time and enable the calculation of the fractional rate of muscle protein synthesis by mass spectrometry.
Measured: : Muscle protein and collagen turnover will be measured at weeks 12 and 18 postpartum.
Muscle Mass Changes Between 6, 12, 18 and 24 Weeks Postpartum
We intend to estimate whole-body muscle mass using D3-Creatine (D3-Cr), measured in urine at weeks 6, 12, 18 and 24 postpartum. Using a creatine-tracer measure of muscle mass, Urine D3-creatine and D3-creatinine and unlabelled creatine and creatinine will be measured by liquid chromatography/mass spectrometry, which will allow the calculation of total body creatine pool size and muscle mass.
Measured: Muscle mass will be measured at weeks 6, 12,18 and 24 postpartum.
Muscle Breakdown Changes Between 12 and 18 Weeks Postpartum
We intend to estimate muscle breakdown using D3-3-methylhistidine (D3-3MH), measured in urine at weeks 12 and 18 postpartum. Isotopic enrichment of D3-3MH in urine will be measured by gas chromatography/mass spectrometry, which will allow the calculation of muscle protein breakdown.
Measured: Muscle breakdown will be measured at weeks 12 and 18 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start4 Jul 2019
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 \[INT\]).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Robert Gordon University, University of Stirling, Ministry of Defence, United Kingdom, Clare Pacey Physiotherapy Limited
- Responsible party
- Principal investigator, Craig Sale, Nottingham Trent University
- Investigators
- Craig Sale, PhD, Principal investigator, Nottingham Trent UniversityKirsty Elliott-Sale, PhD, Principal investigator, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332757
- Sponsor's protocol ID
- 349408
- Other IDs
- ASC/BA/00665
- Acronym
- PERFORM
- Status last verified
- May 2021
- First submitted
- 24 Mar 2020
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elliott-Sale KJ, Bostock EL, Jackson T, Pratt J, Wardle SL, Currie S, Swinton PA, Wilkinson DJ, Atherton PJ, Smith K, O'Leary TJ, Greeves JP, Sale C. Effects of an 18-week postpartum rehabilitation and physical development intervention on occupational physical performance in UK servicewomen. Sci Rep. 2026 Jul 13. doi: 10.1038/s41598-026-60323-1. Online ahead of print.
PubMed 42443273Elliott-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.
PubMed 35648463
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Post-Partum Physical Development Programme on Occupational Physical Performance and Musculoskeletal Health
- ClinicalTrials.gov ID
- NCT04332757
- Acronym / sponsor ID
- PERFORM / 349408
- Conditions
- Postpartum Period
- Keywords
- Performance, Servicewomen, Musculoskeletal, Well-Being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham, Robert Gordon University, University of Stirling, Ministry of Defence, United Kingdom, Clare Pacey Physiotherapy Limited
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 3 Apr 2020 (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.
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:
- Occupational fitness performance;
- Female health assessments (i.e., urinary incontinence, pelvic floor strength);
- Musculoskeletal health;
- Psychological health and wellbeing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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]).
| Arm | Type | Receives |
|---|---|---|
| Training Intervention | Experimental | Other: Training intervention.18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation. |
| Usual care control | No intervention | –Usual care acting as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- < 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].
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 |
|---|---|---|
| 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. | Other | Training Intervention |
Primary outcome
Physical Performance Change Between 12 and 24 Weeks Postpartum
Time frame: Physical performance will be measured at weeks 12 and 24 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.
14 secondary outcomes
Pelvic Organ Prolapse- Quantification System Change in Scores Between 6, 12 and 24 Weeks Postpartum
Time frame: : 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
Time frame: 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
Time frame: : 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
Time frame: 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
Time frame: International consultation on incontinence questionnaire - vaginal symptoms will be measured at weeks 6, 12 and 24 postpartum.
World Health Organisation Quality of Life Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum
Time frame: The World Health Organisation Quality of Life Questionnaire will be measured at weeks 6, 12 and 24 postpartum.
Edinburgh Post Natal Depression Scale, Change in Scores Between 6, 12 and 24 Weeks Postpartum
Time frame: The Edinburgh Post Natal Depression Scale will be measured at weeks 6, 12 and 24 postpartum.
Body Composition Changes Between 6 and 24 Weeks Postpartum
Time frame: Body composition will be measured at weeks 6 and 24 postpartum.
Bone Health Changes Between 6 and 24 Weeks Postpartum
Time frame: Bone health will be measured at weeks 6 and 24 postpartum.
Tendon Properties Changes Between 6, 12 and 24 Weeks Postpartum
Time frame: Tendon properties will be measured at weeks 6, 12 and 24 postpartum.
Muscle Architecture Changes Between 6, 12 and 24 Weeks Postpartum
Time frame: Muscle architecture will be measured at weeks 6, 12 and 24 postpartum.
Muscle Protein and Collagen Turnover Changes Between 12 and 18 Weeks Postpartum
Time frame: : Muscle protein and collagen turnover will be measured at weeks 12 and 18 postpartum.
Muscle Mass Changes Between 6, 12, 18 and 24 Weeks Postpartum
Time frame: Muscle mass will be measured at weeks 6, 12,18 and 24 postpartum.
Muscle Breakdown Changes Between 12 and 18 Weeks Postpartum
Time frame: Muscle breakdown will be measured at weeks 12 and 18 postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Derived from this study: PubMed 42443273Elliott-Sale KJ, Bostock EL, Jackson T, Pratt J, Wardle SL, Currie S, Swinton PA, Wilkinson DJ, Atherton PJ, Smith K, O'Leary TJ, Greeves JP, Sale C. Effects of an 18-week postpartum rehabilitation and physical development intervention on occupational physical performance in UK servicewomen. Sci Rep. 2026 Jul 13. doi: 10.1038/s41598-026-60323-1. Online ahead of print.
- Derived from this study: PubMed 35648463Elliott-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.
- 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.
Craig Sale, PhD principal investigator
Nottingham Trent University
Kirsty Elliott-Sale, PhD principal investigator
Nottingham Trent University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training intervention. in people with Postpartum Period, run by Nottingham Trent University at 11 sites 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Sale, PhD (+44(0)115 848 3505, craig.sale@ntu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Performance Change Between 12 and 24 Weeks Postpartum (time frame: Physical performance will be measured at weeks 12 and 24 postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332757, which also lists 2 linked publications.
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 28 May 2021.