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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
* 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
* 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
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
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.
Time frame: Through intervention period (4 weeks).
Change in Tibia Bone Density & Geometry
Peripheral quantitative computed tomography (pQCT)
Time frame: 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
Time frame: 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) \[all in pg/ml\]
Time frame: 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 \[ug/ml\]
Time frame: 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 \[both ng/ml\]
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
Habitual physical activity
Wrist-worn accelerometry
Time frame: Seven days post-baseline visit.
Self-efficacy for exercise: questionnaire
Self-efficacy for exercise questionnaire
Time frame: 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)
Time frame: 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
Time frame: 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 \[all in kg\])
Time frame: 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)
Time frame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
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