High-impact Exercise in Adults With Crohn's Disease
- Conditions
- Crohn Disease
- Interventions
- Other: High-impact exercise interventionOther: Acute response to high-impact exercise
- Registration Number
- NCT04273399
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Crohn's Disease High-impact exercise intervention Twelve week jumping based exercise intervention Controls High-impact exercise intervention Age and sex matched controls will undertake the same twelve week intervention for active comparison between groups Crohn's Disease Acute response to high-impact exercise Twelve week jumping based exercise intervention Controls Acute response to high-impact exercise Age and sex matched controls will undertake the same twelve week intervention for active comparison between groups
- Primary Outcome Measures
Name Time Method Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention Through intervention period (4 weeks). Adherence to exercise intervention - measured as proportion of exercise sessions completed, and proportion of repetitions completed across intervention.
- Secondary Outcome Measures
Name Time Method 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. Multidimensional Fatigue Scale (CD \& Control group)
Change in Tibia Bone Density & Geometry Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention) Peripheral quantitative computed tomography (pQCT)
Change in Whole Body Bone Density & Composition Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention) Dual energy x-ray absorptiometry scan
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 Pro-inflammatory cytokines in blood (Interleukin \[IL-\] 1Beta, IL-6, IL-17, Tumour necrosis factor alpha) \[all in pg/ml\]
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 Bone specific alkaline phosphatase \[ug/ml\]
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. Inflammatory Bowel Disease Questionnaire (CD Group Only)
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. PedsQL Generic Core Scale (CD \& Control group)
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. Self-efficacy for exercise questionnaire
Change in Lower limb muscle function Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention) Jumping Mechanography
Change in Dietary Intake Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention) Three-day estimated weight food diary
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 C-telopeptide of type I collagen and Sclerostin \[both ng/ml\]
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. Inflammatory Bowel Disease Fatigue questionnaire (CD Group)
Changes in Inflammatory marker in stool sample Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention) Faecal Calprotectin (ug/g)
Habitual physical activity Seven days post-baseline visit. Wrist-worn accelerometry
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. Crohn's disease activity index (CD only)
Change in Body composition Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention) Bio-electrical impedance (Body mass, Fat Mass, Fat Free Mass \[all in kg\])
Trial Locations
- Locations (1)
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
🇬🇧Glasgow, United Kingdom