Clinical trial NCT04273399: High-impact Exercise in Adults With Crohn's Disease
Official title: Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn's Disease
Exercise
Feasibility
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2020-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case control model
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention
timeFrame: Through intervention period (4 weeks).
Secondary outcomes:
measure: Change in Tibia Bone Density & Geometry
timeFrame: Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
measure: Change in Whole Body Bone Density & Composition
timeFrame: Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
measure: Change in Inflammatory Cytokines
timeFrame: 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
measure: Change in Bone Formation Marker
timeFrame: 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
measure: Change in Bone Resorption Marker
timeFrame: 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
measure: Change in Disease Specific Health related quality of life
timeFrame: 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.
measure: Change in Health related quality of life
timeFrame: 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.
measure: Change in disease related Fatigue
timeFrame: 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.
measure: Change in Fatigue
timeFrame: 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.
measure: Change in Lower limb muscle function
timeFrame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
measure: Habitual physical activity
timeFrame: Seven days post-baseline visit.
measure: Self-efficacy for exercise: questionnaire
timeFrame: 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.
measure: Change in Disease activity
timeFrame: 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.
measure: Change in Dietary Intake
timeFrame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
measure: Change in Body composition
timeFrame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
measure: Changes in Inflammatory marker in stool sample
timeFrame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: Jarod Wong
role: PRINCIPAL_INVESTIGATOR
References: