Crohn Disease
Conditions
Keywords
Crohn's Disease, Exercise, Feasibility
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.
Interventions
OTHERHigh-impact exercise intervention
* 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
OTHERAcute response to high-impact exercise
* 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
Sponsors
University of Glasgow
NHS Greater Glasgow and Clyde
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Case control model
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
| 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) |
| 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 Lower limb muscle function | Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention) | Jumping Mechanography |
| Habitual physical activity | Seven days post-baseline visit. | Wrist-worn accelerometry |
| 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 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 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 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 \[all in kg\]) |
| 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) |
| 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) |
Countries
United Kingdom
Contacts
Primary ContactLewis Steell
Backup ContactJarod Wong
Outcome results
None listed