High-impact Exercise in Adults With Crohn's Disease

NCT ID: NCT04273399

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Case control model
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Crohn's Disease

Twelve week jumping based exercise intervention

Group Type EXPERIMENTAL

High-impact exercise intervention

Intervention Type 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

Acute response to high-impact exercise

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

High-impact exercise intervention

Intervention Type 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

Acute response to high-impact exercise

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Glasgow

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jarod Wong

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow & Clyde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Glasgow, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lewis Steell

Role: CONTACT

01414515841

Jarod Wong

Role: CONTACT

01414515841

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lewis Steell

Role: primary

01414515841

Jarod Wong

Role: backup

01414515841

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GN19GA462

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.