Crohn DiseaseIMPACT CDNCT04273399
High-impact Exercise in Adults With Crohn's Disease
A study testing High-impact exercise intervention and Acute response to high-impact exercise in people with Crohn Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- High-impact exercise intervention and Acute response to high-impact exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2020to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Glasgow, G51 4TF
Lewis Steell, 01414515841
Jarod Wong, 01414515841
About this study
Official title: 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.
- Conditions
- Crohn Disease
- Being tested
- High-impact exercise intervention, Acute response to high-impact exercise
- Keywords
- Crohn's Disease, Exercise, Feasibility
- Medical subject headings
- Crohn Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-impact exercise interventionOther
- 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 exerciseOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease | Experimental | Twelve week jumping based exercise intervention Receives: 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 Receives: Other: High-impact exercise intervention; Other: Acute response to high-impact exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through intervention period (4 weeks).
Secondary outcomes (16)
Change in Tibia Bone Density & Geometry
Peripheral quantitative computed tomography (pQCT)
Measured: 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
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
Habitual physical activity
Wrist-worn accelerometry
Measured: Seven days post-baseline visit.
Self-efficacy for exercise: questionnaire
Self-efficacy for exercise questionnaire
Measured: 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)
Measured: 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
Measured: 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])
Measured: 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)
Measured: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case control model
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jarod Wong, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273399
- Sponsor's protocol ID
- GN19GA462
- Acronym
- IMPACT CD
- Status last verified
- Feb 2020
- First submitted
- 8 Jan 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease
- ClinicalTrials.gov ID
- NCT04273399
- Acronym / sponsor ID
- IMPACT CD / GN19GA462
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease, Exercise, Feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Mar 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case control model
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease | Experimental | Other: High-impact exercise intervention, Other: Acute response to high-impact exerciseTwelve week jumping based exercise intervention |
| Controls | Active comparator | Other: High-impact exercise intervention, Other: Acute response to high-impact exerciseAge and sex matched controls will undertake the same twelve week intervention for active comparison between groups |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Controls, Crohn's Disease |
| 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 | Other | Controls, Crohn's Disease |
Primary outcome
Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention
Time frame: Through intervention period (4 weeks).
Adherence to exercise intervention - measured as proportion of exercise sessions completed, and proportion of repetitions completed across intervention.
16 secondary outcomes
Change in Tibia Bone Density & Geometry
Time frame: Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
Change in Whole Body Bone Density & Composition
Time frame: Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
Change in Inflammatory Cytokines
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
Habitual physical activity
Time frame: Seven days post-baseline visit.
Self-efficacy for exercise: questionnaire
Time frame: 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
Time frame: 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
Time frame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
Change in Body composition
Time frame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
Changes in Inflammatory marker in stool sample
Time frame: Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarod Wong principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-impact exercise intervention and Acute response to high-impact exercise in people with Crohn Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lewis Steell (01414515841, lewis.steell@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention (time frame: Through intervention period (4 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.