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

Postpartum Period Clinical Trial

— PERFORM  

Official title:

The Efficacy of a Post-Partum Physical Development Programme on Occupational Physical Performance and Musculoskeletal Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332757
• Other study ID #: 349408
• Secondary ID: ASC/BA/00665
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: September 20, 2022

Study information

• Verified date: May 2021
• Source: Nottingham Trent University
• Contact: Craig Sale, PhD
• Phone: +44(0)115 848 3505
• Email: craig.sale[@]ntu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Period

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Keogh Barracks	Aldershot	Hampshire
United Kingdom	Aldershot Centre for Health,	Aldershot,	Hampshire,
United Kingdom	Minley Medical Centre	Blackwater	Surrey
United Kingdom	MRS Royal Military Academy	Camberley,	Surrey,
United Kingdom	The Princess Royal Barracks	Deepcut	Surrey
United Kingdom	Station Medical Centre	Hook	Hampshire
United Kingdom	Elizabeth Barracks	Pirbright	Surrey
United Kingdom	Bulford Medical Centre	Salisbury	Wiltshire
United Kingdom	Larkhill Medical Centre	Salisbury,	Wiltshire
United Kingdom	Middle Wallop Medical Centre,	Stockbridge,	Hampshire
United Kingdom	Queen Elizabeth Memorial Health Centre	Tidworth	Wiltshire

Sponsors (6)

Lead Sponsor	Collaborator
Nottingham Trent University	Clare Pacey Physiotherapy Limited, Ministry of Defence, United Kingdom, Robert Gordon University, University of Nottingham, University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	: Pelvic Organ Prolapse- Quantification will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	: Musculoskeletal physiotherapy assessment will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	International consultation on incontinence questionnaire - vaginal symptoms will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	The World Health Organisation Quality of Life Questionnaire will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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	The Edinburgh Post Natal Depression Scale will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	Body composition will be measured at weeks 6 and 24 postpartum.
Secondary	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.	Bone health will be measured at weeks 6 and 24 postpartum.
Secondary	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.	Tendon properties will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	Muscle architecture will be measured at weeks 6, 12 and 24 postpartum.
Secondary	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.	: Muscle protein and collagen turnover will be measured at weeks 12 and 18 postpartum.
Secondary	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.	Muscle mass will be measured at weeks 6, 12,18 and 24 postpartum.
Secondary	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.	Muscle breakdown will be measured at weeks 12 and 18 postpartum