High-impact Exercise in Adults With Crohn's Disease

NCT04273399 | Unknown

• 1 other identifier: GN19GA462
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Crohn's Disease; Exercise; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in Tibia Bone Density & Geometry

  Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)

• Change in Whole Body Bone Density & Composition

  Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)

• 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

• 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

• 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

Study Arms (2)

Crohn's Disease

EXPERIMENTAL

Twelve week jumping based exercise intervention

Other: High-impact exercise intervention; Other: Acute response to high-impact exercise

Controls

ACTIVE COMPARATOR

Age and sex matched controls will undertake the same twelve week intervention for active comparison between groups

Other: High-impact exercise intervention; Other: Acute response to high-impact exercise

Interventions

High-impact exercise intervention OTHER

* 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

Controls; Crohn's Disease

Acute response to high-impact exercise OTHER

* 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

Controls; Crohn's Disease

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Motor Activity

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Jarod Wong

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lewis Steell

CONTACT

01414515841; lewis.steell@glasgow.ac.uk

Jarod Wong

CONTACT

01414515841; jarod.wong@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case control model

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: February 18, 2020
• Study Start: March 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)