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

NHS Trust

Status: Unknown

Conditions: Crohn Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04273399

GN19GA462

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Crohn's Disease

Experimental group

Description:

Twelve week jumping based exercise intervention

Treatment:

Other: High-impact exercise intervention

Other: Acute response to high-impact exercise

Controls

Active Comparator group

Description:

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

Treatment:

Other: High-impact exercise intervention

Other: Acute response to high-impact exercise