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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-impact exercise intervention
Acute response to high-impact exercise
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, Exercise, Feasibility

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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)

Sites / Locations

  • Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crohn's Disease

Controls

Arm Description

Twelve week jumping based exercise intervention

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Tibia Bone Density & Geometry
Peripheral quantitative computed tomography (pQCT)
Change in Whole Body Bone Density & Composition
Dual energy x-ray absorptiometry scan
Change in Inflammatory Cytokines
Pro-inflammatory cytokines in blood (Interleukin [IL-] 1Beta, IL-6, IL-17, Tumour necrosis factor alpha) [all in pg/ml]
Change in Bone Formation Marker
Bone specific alkaline phosphatase [ug/ml]
Change in Bone Resorption Marker
C-telopeptide of type I collagen and Sclerostin [both ng/ml]
Change in Disease Specific Health related quality of life
Inflammatory Bowel Disease Questionnaire (CD Group Only)
Change in Health related quality of life
PedsQL Generic Core Scale (CD & Control group)
Change in disease related Fatigue
Inflammatory Bowel Disease Fatigue questionnaire (CD Group)
Change in Fatigue
Multidimensional Fatigue Scale (CD & Control group)
Change in Lower limb muscle function
Jumping Mechanography
Habitual physical activity
Wrist-worn accelerometry
Self-efficacy for exercise: questionnaire
Self-efficacy for exercise questionnaire
Change in Disease activity
Crohn's disease activity index (CD only)
Change in Dietary Intake
Three-day estimated weight food diary
Change in Body composition
Bio-electrical impedance (Body mass, Fat Mass, Fat Free Mass [all in kg])
Changes in Inflammatory marker in stool sample
Faecal Calprotectin (ug/g)

Full Information

First Posted
January 8, 2020
Last Updated
February 17, 2020
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT04273399
Brief Title
High-impact Exercise in Adults With Crohn's Disease
Acronym
IMPACT CD
Official Title
Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's Disease, Exercise, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case control model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crohn's Disease
Arm Type
Experimental
Arm Description
Twelve week jumping based exercise intervention
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Age and sex matched controls will undertake the same twelve week intervention for active comparison between groups
Intervention Type
Other
Intervention Name(s)
High-impact exercise intervention
Intervention Description
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
Intervention Name(s)
Acute response to high-impact exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of participation in high-impact exercise: proportion of exercise sessions completed, and proportion of repetitions completed across intervention
Description
Adherence to exercise intervention - measured as proportion of exercise sessions completed, and proportion of repetitions completed across intervention.
Time Frame
Through intervention period (4 weeks).
Secondary Outcome Measure Information:
Title
Change in Tibia Bone Density & Geometry
Description
Peripheral quantitative computed tomography (pQCT)
Time Frame
Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
Title
Change in Whole Body Bone Density & Composition
Description
Dual energy x-ray absorptiometry scan
Time Frame
Assessed at baseline (pre-intervention) and follow up (<14 days post-intervention)
Title
Change in Inflammatory Cytokines
Description
Pro-inflammatory cytokines in blood (Interleukin [IL-] 1Beta, IL-6, IL-17, Tumour necrosis factor alpha) [all in pg/ml]
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
Title
Change in Bone Formation Marker
Description
Bone specific alkaline phosphatase [ug/ml]
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
Title
Change in Bone Resorption Marker
Description
C-telopeptide of type I collagen and Sclerostin [both ng/ml]
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
Title
Change in Disease Specific Health related quality of life
Description
Inflammatory Bowel Disease Questionnaire (CD Group Only)
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.
Title
Change in Health related quality of life
Description
PedsQL Generic Core Scale (CD & Control group)
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.
Title
Change in disease related Fatigue
Description
Inflammatory Bowel Disease Fatigue questionnaire (CD Group)
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.
Title
Change in Fatigue
Description
Multidimensional Fatigue Scale (CD & Control group)
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.
Title
Change in Lower limb muscle function
Description
Jumping Mechanography
Time Frame
Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
Title
Habitual physical activity
Description
Wrist-worn accelerometry
Time Frame
Seven days post-baseline visit.
Title
Self-efficacy for exercise: questionnaire
Description
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.
Title
Change in Disease activity
Description
Crohn's disease activity index (CD only)
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.
Title
Change in Dietary Intake
Description
Three-day estimated weight food diary
Time Frame
Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (<7 days post-intervention)
Title
Change in Body composition
Description
Bio-electrical impedance (Body mass, Fat Mass, Fat Free Mass [all in kg])
Time Frame
Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)
Title
Changes in Inflammatory marker in stool sample
Description
Faecal Calprotectin (ug/g)
Time Frame
Assessed at baseline (pre-intervention), mid-point of intervention (Week 7) and follow up (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lewis Steell
Phone
01414515841
Email
lewis.steell@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jarod Wong
Phone
01414515841
Email
jarod.wong@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarod Wong
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lewis Steell
Phone
01414515841
First Name & Middle Initial & Last Name & Degree
Jarod Wong
Phone
01414515841
First Name & Middle Initial & Last Name & Degree
Jarod Wong
First Name & Middle Initial & Last Name & Degree
Lewis Steell

12. IPD Sharing Statement

Plan to Share IPD
No

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High-impact Exercise in Adults With Crohn's Disease

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