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临床试验/NCT04332757
NCT04332757Unknown不适用

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

Nottingham Trent University11 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年7月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
11
主要终点
Physical Performance Change Between 12 and 24 Weeks Postpartum

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •< 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.

研究组 & 干预措施

Training Intervention

Experimental

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

干预措施: Training intervention. (Other)

Usual care control

No Intervention

Usual care acting as a control group.

结局指标

主要结局

Physical Performance Change Between 12 and 24 Weeks Postpartum

时间窗: 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.

次要结局

  • Edinburgh Post Natal Depression Scale, Change in Scores Between 6, 12 and 24 Weeks Postpartum(The Edinburgh Post Natal Depression Scale will be measured at weeks 6, 12 and 24 postpartum.)
  • Bone Health Changes Between 6 and 24 Weeks Postpartum(Bone health will be measured at weeks 6 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.)
  • Body Composition Changes Between 6 and 24 Weeks Postpartum(Body composition will be measured at weeks 6 and 24 postpartum.)
  • Muscle Mass Changes Between 6, 12, 18 and 24 Weeks Postpartum(Muscle mass will be measured at weeks 6, 12,18 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 will be measured at weeks 6, 12 and 24 postpartum.)
  • 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 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.)
  • Tendon Properties Changes Between 6, 12 and 24 Weeks Postpartum(Tendon properties will be measured at weeks 6, 12 and 24 postpartum.)
  • Muscle Breakdown Changes Between 12 and 18 Weeks Postpartum(Muscle breakdown will be measured at weeks 12 and 18 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.)
  • 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.)
  • Muscle Architecture Changes Between 6, 12 and 24 Weeks Postpartum(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 and collagen turnover will be measured at weeks 12 and 18 postpartum.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Sale

Professor of Human Physiology, Director of the Sport, Health and Performance Enhancement Research Centre

Nottingham Trent University

研究点 (11)

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