Postpartum Exercise and Return to Fitness: Optimise Readiness for Military Mums (PERFORM) (PERFORM)
2021년 5월 26일 업데이트: Craig Sale, Nottingham Trent University
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Craig Sale, PhD
- 전화번호: +44(0)115 848 3505
- 이메일: craig.sale@ntu.ac.uk
연구 연락처 백업
- 이름: Kirsty Elliott-Sale, PhD
- 전화번호: +44(0)115 848 6338
- 이메일: kirsty.elliottsale@ntu.ac.uk
연구 장소
-
-
Hampshire
-
Aldershot, Hampshire, 영국, GU12 5RQ
- 모병
- Keogh Barracks
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
Hook, Hampshire, 영국, RG29 1QT
- 모병
- Station Medical Centre
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
Stockbridge,, Hampshire, 영국, SO20 8DY
- 모병
- Middle Wallop Medical Centre,
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
-
Hampshire,
-
Aldershot,, Hampshire,, 영국, GU11 1AY
- 모병
- Aldershot Centre for Health,
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
-
Surrey
-
Blackwater, Surrey, 영국, Gu17 9LP
- 모병
- Minley Medical Centre
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
Deepcut, Surrey, 영국, GU16 6SQ
- 모병
- The Princess Royal Barracks
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
Pirbright, Surrey, 영국, GU24 oDT
- 모병
- Elizabeth Barracks
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
-
Surrey,
-
Camberley,, Surrey,, 영국, GU15 4PQ
- 모병
- MRS Royal Military Academy
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
-
Wiltshire
-
Salisbury, Wiltshire, 영국, SP4 9AD
- 모병
- Bulford Medical Centre
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
Salisbury,, Wiltshire, 영국, SP4 8QY
- 모병
- Larkhill Medical Centre
-
연락하다:
- Elaine Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
부수사관:
- Emma Bostock, PhD
-
Tidworth, Wiltshire, 영국, SP9 7EA
- 모병
- Queen Elizabeth Memorial Health Centre
-
부수사관:
- Emma Bostock, PhD
-
연락하다:
- Elaine S Walker
- 전화번호: 01980 650640
- 이메일: Elaine.Walker907@mod.gov.uk
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- < 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Training Intervention
18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation.
|
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.
|
|
간섭 없음: Usual care control
Usual care acting as a control group.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physical Performance Change Between 12 and 24 Weeks Postpartum
기간: 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.
|
Physical performance will be measured at weeks 12 and 24 postpartum.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pelvic Organ Prolapse- Quantification System Change in Scores Between 6, 12 and 24 Weeks Postpartum
기간: : Pelvic Organ Prolapse- Quantification will be measured at weeks 6, 12 and 24 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.
|
|
Pelvic Floor Strength Change in Scores Between 6,12 and 24 Weeks Postpartum
기간: Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 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.
|
|
Musculoskeletal Physiotherapy Assessment Change Between 6,12 and 24 Weeks Postpartum
기간: : Musculoskeletal physiotherapy assessment will be measured at weeks 6, 12 and 24 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.
|
|
Pelvic Floor Distress Inventory Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum
기간: Pelvic floor distress inventory questionnaire will be measured at weeks 6, 12 and 24 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.
|
|
International Consultation on Incontinence Questionnaire - Vaginal Symptoms, Change in Scores Between 6, 12 and 24 Weeks Postpartum
기간: International consultation on incontinence questionnaire - vaginal symptoms will be measured at weeks 6, 12 and 24 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.
|
|
World Health Organisation Quality of Life Questionnaire, Change in Scores Between 6, 12 and 24 Weeks Postpartum
기간: The World Health Organisation Quality of Life Questionnaire will be measured at weeks 6, 12 and 24 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.
|
|
Edinburgh Post Natal Depression Scale, Change in Scores Between 6, 12 and 24 Weeks Postpartum
기간: The Edinburgh Post Natal Depression Scale will be measured at weeks 6, 12 and 24 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.
|
|
Body Composition Changes Between 6 and 24 Weeks Postpartum
기간: Body composition will be measured at weeks 6 and 24 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.
|
|
Bone Health Changes Between 6 and 24 Weeks Postpartum
기간: Bone health will be measured at weeks 6 and 24 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.
|
|
Tendon Properties Changes Between 6, 12 and 24 Weeks Postpartum
기간: Tendon properties will be measured at weeks 6, 12 and 24 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.
|
|
Muscle Architecture Changes Between 6, 12 and 24 Weeks Postpartum
기간: Muscle architecture will be measured at weeks 6, 12 and 24 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.
|
|
Muscle Protein and Collagen Turnover Changes Between 12 and 18 Weeks Postpartum
기간: : Muscle protein and collagen turnover will be measured at weeks 12 and 18 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.
|
|
Muscle Mass Changes Between 6, 12, 18 and 24 Weeks Postpartum
기간: Muscle mass will be measured at weeks 6, 12,18 and 24 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.
|
|
Muscle Breakdown Changes Between 12 and 18 Weeks Postpartum
기간: Muscle breakdown will be measured at weeks 12 and 18 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Craig Sale, PhD, Nottingham Trent University
- 수석 연구원: Kirsty Elliott-Sale, PhD, Nottingham Trent University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 7월 4일
기본 완료 (예상)
2022년 9월 20일
연구 완료 (예상)
2022년 9월 20일
연구 등록 날짜
최초 제출
2020년 3월 24일
QC 기준을 충족하는 최초 제출
2020년 3월 31일
처음 게시됨 (실제)
2020년 4월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 26일
마지막으로 확인됨
2021년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 349408
- ASC/BA/00665 (기타 보조금/기금 번호: ASC Contract Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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