We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05174754
Recruitment Status : Not yet recruiting
First Posted : January 3, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Behavioral: Physician-prescribed Exercise Programme Drug: Best Medical Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 24, 2022
Estimated Primary Completion Date : November 22, 2022
Estimated Study Completion Date : May 22, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inflammatory Bowel Disease Exercise Group
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.
Behavioral: Physician-prescribed Exercise Programme
A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles

Drug: Best Medical Therapy
Best medical therapy with biologic agent or small-molecule therapy

Inflammatory Bowel Disease Control Group
The IBD control group will be randomized to best medical therapy alone.
Drug: Best Medical Therapy
Best medical therapy with biologic agent or small-molecule therapy

No Intervention: Healthy Control Group
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.



Primary Outcome Measures :
  1. A change in physical fitness between the IBD patient arms [ Time Frame: 26 weeks ]
    15% difference in 6-minute walk test (6MWT) distance between the two groups


Secondary Outcome Measures :
  1. Change in body composition (fat mass) as measured by dual-energy x-ray absorptiometry [ Time Frame: 26 weeks ]

    Measured using body composition analysis by

    - Dual-energy x-ray absorptiometry (DEXA) (Fat mass index (FMI = Fat mass / Height2)


  2. Change in body composition (muscle mass) as measured by dual-energy x-ray absorptiometry [ Time Frame: 26 weeks ]

    Measured using body composition analysis by

    - Dual-energy x-ray absorptiometry (DEXA) appendicular lean mass index (ALMI = [arms + legs lean mass] / Height2))


  3. Change in muscle mass measured by ultrasound [ Time Frame: 26 weeks ]
    Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm)

  4. Change in muscle mass measured by bioelectrical impedance analysis [ Time Frame: 26 weeks ]
    Bioelectrical impedance analysis (muscle mass in Kg)

  5. Change in visceral fat measured by bioelectrical impedance analysis [ Time Frame: 26 weeks ]
    Bioelectrical impedance analysis (visceral fat in Kg)

  6. Clinical remission in response to exercise intervention [ Time Frame: 12 and 26 weeks ]
    Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis

  7. Change in fatigue score between the IBD groups in response to exercise [ Time Frame: 12 and 26 weeks ]
    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").

  8. Change in Quality of Life in response to exercise [ Time Frame: 12 and 26 weeks ]
    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.

  9. Change in endoscopic disease activity between IBD groups [ Time Frame: 26 weeks ]
    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).

  10. Inflammatory response between IBD groups measured using biomarkers of disease activity [ Time Frame: 12 and 26 weeks ]
    Change in C-Reactive Protein (mg/L)

  11. Inflammatory response between IBD groups measured using biomarkers of disease activity [ Time Frame: 12 and 26 weeks ]
    Change in faecal calprotectin (ug/g)

  12. Inflammatory response between IBD groups measured using biomarkers of disease activity [ Time Frame: 12 and 26 weeks ]
    Change in circulating pro-inflammatory cytokines (pg/mL)

  13. Change in handgrip strength [ Time Frame: 12 and 26 weeks ]
    Use of Jamar dynamometer to measure handgrip strength in kPa


Other Outcome Measures:
  1. Measurement of metabolic markers in response to exercise [ Time Frame: 12 and 26 weeks ]
    Analysis of key immunometabolic pathways including flow cytometry of peripheral T-cells



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05174754


Contacts
Layout table for location contacts
Contact: Karen Boland, PhD 018092810 karenjboland@gmail.com
Contact: Neasa Mc Gettigan, MB BCh, MSc 018092810 neasamcgettigan21@rcsi.com

Locations
Layout table for location information
Ireland
Beaumont Hospital
Dublin, Ireland
Contact: Neasa Mc Gettigan    +35318092810    neasamcgettigan21@rcsi.com   
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Investigators
Layout table for investigator information
Principal Investigator: Karen Boland, PhD Royal College of Surgeons, Ireland and Beaumont Hospital, Dublin, Ireland.
Publications:

Layout table for additonal information
Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT05174754    
Other Study ID Numbers: 21-048
First Posted: January 3, 2022    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis