Back to resultsResponse To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme
Primary Purpose
Inflammatory Bowel Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Physician-prescribed Exercise Programme
Best Medical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or above.
- Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
- Be able to provide written informed consent.
- Stable dose of steroids.
- Physically able to complete an exercise programme.
- Healthy controls.
Exclusion Criteria:
- Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
- An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
- A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
- Pregnancy.
- Healthy controls with underlying inflammatory conditions.
Sites / Locations
- Beaumont HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
No Intervention
Arm Label
Inflammatory Bowel Disease Exercise Group
Inflammatory Bowel Disease Control Group
Healthy Control Group
Arm Description
The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes.
The IBD control group will be randomized to best medical therapy alone.
A group of healthy controls without inflammatory bowel disease will be included in the study for comparison of inflammatory markers including cytokine analysis and body composition.
Outcomes
Primary Outcome Measures
The recruitment rates in both IBD arms.
A calculation of the percentage of people approached who participate in the intervention (recruitment).
The retention rate in both IBD arms.
A calculation of the percentage of people approached who complete the intervention.
The adherence rate in both IBD arms.
A calculation of the percentage of people approached who adhered to the intervention.
Secondary Outcome Measures
Change in muscle mass measured by ultrasound
Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm)
Change in muscle mass measured by bioelectrical impedance analysis
Bioelectrical impedance analysis (muscle mass in Kg)
Change in visceral fat measured by bioelectrical impedance analysis
Bioelectrical impedance analysis (visceral fat in Kg)
Clinical remission in response to exercise intervention
Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis
Change in fatigue score between the IBD groups in response to exercise
Measured using the Fatigue Severity Scale which comprises nine statements, describing the severity and impact of fatigue, with a scale of possible responses ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Change in Quality of Life in response to exercise
Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)- a ten item questionnaire, with 1 to 7 points for each item and higher scores indicating higher quality of life.
Change in endoscopic disease activity between IBD groups
A change in endoscopic appearance of Crohn's using Simple endoscopic score for Crohn's disease (SES CD) (inactive when SES-CD was 0-2; mild when 3-6; moderate 7-15; and severe >16) or Mayo score for ulcerative colitis (Score 0-3, Mayo 3 indicating severe disease, 2 moderate disease, 1 mild disease and 0 inactive).
Inflammatory response between IBD groups measured using C-Reactive protein
Change in C-Reactive Protein (mg/L)
Inflammatory response between IBD groups measured using faecal calprotectin
Change in faecal calprotectin (ug/g)
Inflammatory response between IBD groups measured using pro-inflammatory cytokines
Change in circulating pro-inflammatory cytokines (pg/mL)
Change in handgrip strength
Use of Jamar dynamometer to measure handgrip strength in kPa
A change in physical fitness between the IBD patient arms
15% difference in 6-minute walk test (6MWT) distance between the two groups
Full Information
NCT ID
NCT05174754
First Posted
November 8, 2021
Last Updated
October 27, 2022
Sponsor
Royal College of Surgeons, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT05174754
Brief Title
Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme
Official Title
The Impact Of A Physician-led Exercise Programme On Quality Of Life, Muscle Mass And Clinical Response In Inflammatory Bowel Disease Patients During Induction With Medical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
March 22, 2023 (Anticipated)
Study Completion Date
May 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.
Detailed Description
After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inflammatory Bowel Disease Exercise Group
Arm Type
Experimental
Arm Description
The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes.
Arm Title
Inflammatory Bowel Disease Control Group
Arm Type
Other
Arm Description
The IBD control group will be randomized to best medical therapy alone.
Arm Title
Healthy Control Group
Arm Type
No Intervention
Arm Description
A group of healthy controls without inflammatory bowel disease will be included in the study for comparison of inflammatory markers including cytokine analysis and body composition.
Intervention Type
Behavioral
Intervention Name(s)
Physician-prescribed Exercise Programme
Intervention Description
A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles
Intervention Type
Drug
Intervention Name(s)
Best Medical Therapy
Intervention Description
Best medical therapy with biologic agent or small-molecule therapy
Primary Outcome Measure Information:
Title
The recruitment rates in both IBD arms.
Description
A calculation of the percentage of people approached who participate in the intervention (recruitment).
Time Frame
26 weeks
Title
The retention rate in both IBD arms.
Description
A calculation of the percentage of people approached who complete the intervention.
Time Frame
26 weeks
Title
The adherence rate in both IBD arms.
Description
A calculation of the percentage of people approached who adhered to the intervention.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Change in muscle mass measured by ultrasound
Description
Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm)
Time Frame
26 weeks
Title
Change in muscle mass measured by bioelectrical impedance analysis
Description
Bioelectrical impedance analysis (muscle mass in Kg)
Time Frame
26 weeks
Title
Change in visceral fat measured by bioelectrical impedance analysis
Description
Bioelectrical impedance analysis (visceral fat in Kg)
Time Frame
26 weeks
Title
Clinical remission in response to exercise intervention
Description
Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis
Time Frame
12 and 26 weeks
Title
Change in fatigue score between the IBD groups in response to exercise
Description
Measured using the Fatigue Severity Scale which comprises nine statements, describing the severity and impact of fatigue, with a scale of possible responses ranging from 1 ("strongly disagree") to 7 ("strongly agree").
Time Frame
12 and 26 weeks
Title
Change in Quality of Life in response to exercise
Description
Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)- a ten item questionnaire, with 1 to 7 points for each item and higher scores indicating higher quality of life.
Time Frame
12 and 26 weeks
Title
Change in endoscopic disease activity between IBD groups
Description
A change in endoscopic appearance of Crohn's using Simple endoscopic score for Crohn's disease (SES CD) (inactive when SES-CD was 0-2; mild when 3-6; moderate 7-15; and severe >16) or Mayo score for ulcerative colitis (Score 0-3, Mayo 3 indicating severe disease, 2 moderate disease, 1 mild disease and 0 inactive).
Time Frame
26 weeks
Title
Inflammatory response between IBD groups measured using C-Reactive protein
Description
Change in C-Reactive Protein (mg/L)
Time Frame
12 and 26 weeks
Title
Inflammatory response between IBD groups measured using faecal calprotectin
Description
Change in faecal calprotectin (ug/g)
Time Frame
12 and 26 weeks
Title
Inflammatory response between IBD groups measured using pro-inflammatory cytokines
Description
Change in circulating pro-inflammatory cytokines (pg/mL)
Time Frame
12 and 26 weeks
Title
Change in handgrip strength
Description
Use of Jamar dynamometer to measure handgrip strength in kPa
Time Frame
12 and 26 weeks
Title
A change in physical fitness between the IBD patient arms
Description
15% difference in 6-minute walk test (6MWT) distance between the two groups
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
Measurement of metabolic markers in response to exercise
Description
Analysis of key immunometabolic pathways including flow cytometry of peripheral T-cells
Time Frame
12 and 26 weeks
Title
Adverse events
Description
The frequency and nature of adverse events will be recorded (number, percentage and type).
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or above.
Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
Be able to provide written informed consent.
Stable dose of steroids.
Physically able to complete an exercise programme.
Healthy controls.
Exclusion Criteria:
Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
Pregnancy.
Healthy controls with underlying inflammatory conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Boland, PhD
Phone
018092810
Email
karenjboland@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neasa Mc Gettigan, MB BCh, MSc
Phone
018092810
Email
neasamcgettigan21@rcsi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Boland, PhD
Organizational Affiliation
Royal College of Surgeons, Ireland and Beaumont Hospital, Dublin, Ireland.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neasa Mc Gettigan
Phone
+35318092810
Email
neasamcgettigan21@rcsi.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Citation
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Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme
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