High-impact Exercise in Adults With Crohn's Disease (IMPACT CD)

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

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 Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Other: High-impact exercise intervention; Other: Acute response to high-impact exercise

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lewis Steell; Phone Number: 01414515841; Email: lewis.steell@glasgow.ac.uk
• Study Contact Backup: Name: Jarod Wong; Phone Number: 01414515841; Email: jarod.wong@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
    • Contact: Lewis Steell; Phone Number: 01414515841
    • Contact: Jarod Wong; Phone Number: 01414515841
    • Principal Investigator: Jarod Wong
    • Sub-Investigator: Lewis Steell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crohn's Disease; Twelve week jumping based exercise 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; Other: 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
Active Comparator: Controls; Age and sex matched controls will undertake the same twelve week intervention for active comparison between groups	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; Other: 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Jarod Wong, NHS Greater Glasgow & Clyde

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Feasibility; Crohn's Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: GN19GA462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No