High-impact Exercise in Adults With Crohn's Disease

Crohn Disease Clinical Trial

— IMPACT CD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04273399
• Other study ID #: GN19GA462
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: October 2021

Study information

• Verified date: February 2020
• Source: NHS Greater Glasgow and Clyde
• Contact: Lewis Steell
• Phone: 01414515841
• Email: lewis.steell[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• High-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
• Acute 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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Tibia Bone Density & Geometry	Peripheral quantitative computed tomography (pQCT)	Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	Habitual physical activity	Wrist-worn accelerometry	Seven days post-baseline visit.
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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)