Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention
研究概览
简要总结
Crohn's disease increases the risk of poor musculoskeletal health, as the inflammatory disease process directly inhibits regulatory pathways involved in bone and muscle formation and maintenance. The negative effects of disease on muscle-bone health are compounded by poor nutritional status, vitamin d deficiency, prolonged exposure to glucocorticoid therapy, and reduced physical activity. Modern, steroid sparing therapies are successful at inducing clinical remission in terms of inflammation, however they have limited effect in remedying observed muscle-bone deficits. Subsequently, patients with Crohn's disease are at increased lifelong risk of pathological fractures and osteoporosis. Novel adjunctive therapies are therefore required to complement pharmacological treatments and target muscle-bone deficits, which are responsible for significant disease burden in Crohn's.
High-impact exercise may be a useful additional therapy for patients with Crohn's disease, as the mechanical strains produced during this type of exercise, through large magnitude muscular contractions and ground reaction forces, can promote bone formation and gains in muscle mass. There have been no previous studies assessing the effects of high impact exercise in Crohn's disease, so it is unknown if this type of exercise is safe and feasible in this population. The aim of this study is to assess the feasibility of high-impact exercise for improving markers of bone and muscle health in adults with Crohn's disease, and compare the effects of exercise with a group of healthy age and sex matched controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Crohn's disease diagnosed at least six months ago
- •Stable medication for at least four weeks
- •Disease in remission, or mildly/moderately active according to Harvey Bradshaw Index score
- •Currently undertaking <2 hours of structured exercise per week
- •Able to mobilise and exercise independently
- •Able to provide written informed consent
排除标准
- •Surgery <12 weeks or planned surgery during intervention period
- •Comorbidity known to affect muscle / bone
- •Contraindication to high-impact exercise
- •Pregnancy or planned pregnancy during intervention period
- •BMI >40 kg/m2 (or body mass >120kg)
结局指标
主要结局
Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention
时间窗: Through intervention period (4 weeks).
Adherence to exercise intervention - measured as proportion of exercise sessions completed, and proportion of repetitions completed across intervention.
次要结局
- Change in Fatigue(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention). Scale 0 - 100, higher score equals less problems with fatigue.)
- Change in Tibia Bone Density & Geometry(Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention))
- Change in Whole Body Bone Density & Composition(Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention))
- Change in Inflammatory Cytokines(Intervention effects: Bloods measured at baseline (pre-intervention), midpoint of intervention (Week 7) and <7 days post-intervention to assess changes. Acute effects of exercise: measured pre-exercise, then 0, 15, 30 and 60 minutes post-exercise)
- Change in Bone Formation Marker(Intervention effects: Bloods measured at baseline (pre-intervention), midpoint of intervention (Week 7) and <7 days post-intervention to assess changes. Acute effects of exercise: measured pre-exercise, then 0, 15, 30 and 60 minutes post-exercise)
- Change in Disease Specific Health related quality of life(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention). Scale 32 - 224; higher score means better quality of life.)
- Change in Health related quality of life(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention). Scale 0 to 100, higher score equals better quality of life.)
- Self-efficacy for exercise: questionnaire(Pre-intervention. Self-efficacy for exercise scale: Nine-item scale, score 0-10 per item. Min value 0, Max Value 90. Higher score equals better self-efficacy.)
- Change in Lower limb muscle function(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention))
- Change in Dietary Intake(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention))
- Change in Bone Resorption Marker(Intervention effects: Bloods measured at baseline (pre-intervention), midpoint of intervention (Week 7) and <7 days post-intervention to assess changes. Acute effects of exercise: measured pre-exercise, then 0, 15, 30 and 60 minutes post-exercise)
- Change in disease related Fatigue(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention). Scale 0 - 120, lower score equals less problems with fatigue.)
- Changes in Inflammatory marker in stool sample(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention))
- Habitual physical activity(Seven days post-baseline visit.)
- Change in Disease activity(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention). Scale 0 to >450. Score 0-150 = remission, 151-220 = mild disease, 220-450 = moderate disease, >450 = severe disease.)
- Change in Body composition(Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention))