High-impact Exercise in Adults With Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: High-impact exercise intervention
* Other: Acute response to high-impact exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case control model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crohn's Disease<br>Twelve week jumping based exercise intervention | Other: High-impact exercise intervention<br>* Twelve-week high-impact exercise intervention Majority home based sessions, some supervised sessions Three exercise sessions per week Between 50 - 100 jumps per session Progressive jumping exercises to increase mechanical loading<br>Other: Acute response to high-impact exercise<br>* First session of twelve-week high-impact exercise session used to assess the acute physiological response to one session of high-impact exercise in both Crohn's disease and healthy controls One supervised session of high-impact exercise Bloods to assess acute inflammatory and bone turnover response post-exercise<br>|
| Active Comparator: Controls<br>Age and sex matched controls will undertake the same twelve week intervention for active comparison between groups | Other: High-impact exercise intervention<br>* Twelve-week high-impact exercise intervention Majority home based sessions, some supervised sessions Three exercise sessions per week Between 50 - 100 jumps per session Progressive jumping exercises to increase mechanical loading<br>Other: Acute response to high-impact exercise<br>* First session of twelve-week high-impact exercise session used to assess the acute physiological response to one session of high-impact exercise in both Crohn's disease and healthy controls One supervised session of high-impact exercise Bloods to assess acute inflammatory and bone turnover response post-exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention | Adherence to exercise intervention - measured as proportion of exercise sessions completed, and proportion of repetitions completed across intervention. | Through intervention period (4 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tibia Bone Density & Geometry | Peripheral quantitative computed tomography (pQCT) | Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention) | 
| Change in Whole Body Bone Density & Composition | Dual energy x-ray absorptiometry scan | Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention) | 
| Change in Inflammatory Cytokines | Pro-inflammatory cytokines in blood (Interleukin [IL-] 1Beta, IL-6, IL-17, Tumour necrosis factor alpha) [all in pg/ml] | 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 | Bone specific alkaline phosphatase [ug/ml] | 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 Resorption Marker | C-telopeptide of type I collagen and Sclerostin [both ng/ml] | 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 | Inflammatory Bowel Disease Questionnaire (CD Group Only) | 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 | PedsQL Generic Core Scale (CD & Control group) | 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. | 
| Change in disease related Fatigue | Inflammatory Bowel Disease Fatigue questionnaire (CD Group) | 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. | 
| Change in Fatigue | Multidimensional Fatigue Scale (CD & Control group) | 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 Lower limb muscle function | Jumping Mechanography | Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention) | 
| Habitual physical activity | Wrist-worn accelerometry | Seven days post-baseline visit. | 
| Self-efficacy for exercise: questionnaire | 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 Disease activity | Crohn's disease activity index (CD only) | 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 Dietary Intake | Three-day estimated weight food diary | Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention) | 
| Change in Body composition | Bio-electrical impedance (Body mass, Fat Mass, Fat Free Mass [all in kg]) | Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention) | 
| Changes in Inflammatory marker in stool sample | Faecal Calprotectin (ug/g) | Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Exercise, Feasibility