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Effects of Exercise in Patients With Ulcerative Colitis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143490
Recruitment Status : Suspended (Due to Covid-19)
First Posted : October 29, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Adora Yau, Manchester Metropolitan University

Brief Summary:
The aim of this study is to investigate the effects of moderate to high intensity exercise on gut function and inflammatory markers in patients with Ulcerative Colitis (UC), and to compare them with individuals of matched age who do not suffer from Inflammatory Bowel Disease. Participants will be asked to complete 60 minutes of continuous cycling at a moderate to high intensity followed by a three hour recovery period. Gastrointestinal function will be measured using a non-invasive breath test. Blood samples will be collected at multiple time-points during the visit and these samples will be measured for markers of immune function and intestinal integrity.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Diseases Other: Exercise Not Applicable

Detailed Description:

There is limited research on the effect of exercise on patients with Ulcerative Colitis. The aim of this investigation is to study the acute effects of moderate to high intensity exercise on gut function in patients with Ulcerative Colitis and to compare them with individuals of matched age who do not suffer from Inflammatory Bowel Disease.

Patients in remission from disease activity and age and gender matched healthy control participants will be recruited from the general population. Participants will attend the laboratory on two occasions. The first visit will last approximately one hour and will include an exercise test to determine peak oxygen uptake capacity (VO2peak) which is an indicator of cardiorespiratory fitness. The second visit will last for approximately four and a half hours and will consist of a 60 minute continuous cycle on a stationary cycle ergometer at an intensity of 65% VO2peak followed by a recovery period. Gastric emptying rate of a commercially available sports drink will be measured and blood samples will be collected at regular time-points throughout the visit and analysed for concentrations of inflammatory markers and intestinal integrity/function.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single experimental trial with a UC patient group and an age and gender matched healthy control group
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Exercise Intensity on Gastrointestinal Function and Inflammatory Markers in Patients With Ulcerative Colitis
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UC Patients
Patient group
Other: Exercise
60 minutes of continuous exercise at 65% VO2peak and drink ingestion

Active Comparator: Healthy controls
Control group
Other: Exercise
60 minutes of continuous exercise at 65% VO2peak and drink ingestion




Primary Outcome Measures :
  1. Change in inflammatory markers or hormones [ Time Frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours ]
    Circulating concentrations of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2

  2. Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones [ Time Frame: 4.5 hours ]
    Responses of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2

  3. Change in intestinal epithelial damage and permeability markers [ Time Frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours ]
    Circulating concentrations of intestinal fatty acid binding protein and claudin-3

  4. Area under the circulating concentration versus time curve (AUC) of intestinal epithelial damage and permeability markers [ Time Frame: 4.5 hours ]
    Responses of intestinal fatty acid binding protein and claudin-3

  5. Change in exercise induced endotoxaemia markers [ Time Frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours ]
    Circulating concentrations of plasma lipopolysaccharide

  6. Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers [ Time Frame: 4.5 hours ]
    Response of plasma lipopolysaccharide

  7. Gastric emptying rate half time and time of maximal emptying rate [ Time Frame: 2 hours after ingestion of drink ]
    Emptying rate of a commercially available sports drink from the stomach using the 13C breath test method

  8. Change in ratio of 13C/12C in breath samples [ Time Frame: 9 breath samples collected at baseline, then every 15 minutes after ingestion for 2 hours ]
    Gastric emptying profile of a commercially available sports drink from the stomach using the 13C breath test method


Secondary Outcome Measures :
  1. Incidence and severity of gastrointestinal symptoms [ Time Frame: Immediately post-exercise bout and 3 hours post exercise. ]
    10-point rating scale for gastrointestinal symptoms (Visual Analogue Scale modified). 19 item questionnaire with 5 subcategories (Overall gut discomfort, total gastrointestinal symptoms, upper gastrointestinal symptoms, lower gastrointestinal symptoms and other gastrointestinal symptoms). Scores for each item ranging from 0 (no symptom) to 10 (extremely severe symptoms causing exercise reduction, stopping, or complete withdrawal). Higher scores represent higher severity of symptoms.

  2. Heart rate response [ Time Frame: Every 5 minutes during 60 minute cycle ]
    Heart rate telemetry

  3. Disparity of subjective exertion and objective cardiorespiratory parameters [ Time Frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes ]
    Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and cardiopulmonary exercise testing variables of oxygen uptake, carbon dioxide expiration, ventilatory threshold, volume of air expired, and tidal volume (all parameters measured in L/min).

  4. Disparity of subjective exertion and objective heart rate [ Time Frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes ]
    Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and heart rate measured by telemetry

  5. Disparity of subjective exertion and breathing frequency [ Time Frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes ]
    Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and number of breaths per minute

  6. Disparity of subjective exertion and oxygen pulse [ Time Frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes ]
    Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and oxygen pulse calculated by dividing oxygen uptake by heart rate.

  7. Disparity of subjective exertion and respiratory exchange ratio [ Time Frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes ]
    Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and respiratory exchange ratio calculated by dividing carbon dioxide production by oxygen uptake.

  8. Disparity of subjective exertion and ventilatory efficiency [ Time Frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes ]
    Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and minute ventilation/carbon dioxide slope (VE/VCO2 slope).

  9. Subjective physical activity levels [ Time Frame: Prior to experimental trial ]
    International Physical Activity Questionnaire (IPAQ). Answers to questions (time spent completing different physical activities) converted to Metabolic Equivalent (METs) hours per week. Minimum value of zero, no limit to maximum. Higher MET values indicate higher physical activity levels.

  10. Attitudes and beliefs towards physical activity [ Time Frame: Prior to experimental trial ]
    Barriers to Physical Activity Questionnaire. 21 item questionnaire, each question rated from 0 (very unlikely) to 3 (very likely). Each item belongs to one of 7 categories relating to barriers to physical activity. Score totals greater than 5 indicate the category as being a significant barrier.

  11. Subjective health related quality of life: RAND 36-Item Short Form Health Survey (SF-36) [ Time Frame: Prior to experimental trial ]
    RAND 36-Item Short Form Health Survey (SF-36). 36-item questionnaire covering 8 concepts; physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions, plus single item providing an indication of perceived change in health. Scores ranging from 0 to 100 for each concept with 100 indicating good health and 0 being poor health.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For ulcerative colitis patients;

  • Currently in remission of disease (asymptomatic at time of experiment)
  • Less than 3 periods of disease activity (periods of symptomatic activity) in the last 12 months
  • No history of surgery to alleviate condition severity
  • Taking regular standard medication for control of condition
  • Adult less than 50 years due to effects of exercise in older age
  • Non-smokers
  • Regular exercisers (determined via verbal discussion)

For healthy controls;

  • No history of disease (as assessed by standard medical screening questionnaire)
  • Adult less than 50 years due to effects of exercise in older age
  • Non-smokers
  • Regular exercisers (determined via verbal discussion)

Exclusion Criteria:

For ulcerative colitis patients;

  • Currently in active period of disease (symptomatic at time of experiment)
  • More than 3 periods of disease activity (periods of symptomatic activity) in the last 12 months
  • History of surgery to alleviate condition severity
  • Taking non-standard medication for control of condition
  • Adult more than 50 years of age
  • Under 18 years of age
  • Smokers
  • Sedentary or not regularly physically active (determined via verbal discussion)

For healthy controls;

  • History of disease (as assessed by standard medical screening questionnaire)
  • Adult more than 50 years of age
  • Under 18 years of age
  • Smokers
  • Sedentary or not regularly physically active (determined via verbal discussion)

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): NCT04143490


Locations
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United Kingdom
Manchester Metropolitan University
Manchester, Greater Manchester, United Kingdom, M1 5GD
Sponsors and Collaborators
Manchester Metropolitan University
University of Manchester
Investigators
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Principal Investigator: Gethin H Evans, PhD Manchester Metropolitan University
Principal Investigator: Adora MW Yau, PhD Manchester Metropolitan University
Principal Investigator: John McLaughlin, Prof. University of Manchester
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Responsible Party: Adora Yau, Lecturer, Manchester Metropolitan University
ClinicalTrials.gov Identifier: NCT04143490    
Other Study ID Numbers: ExerciseUC-2019
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Planned communication of group results at a scientific conference. Planned publication in a scientific peer reviewed journal. Participant level data is not expected to be available as this complies with the conditions of the ethical approval granted for this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adora Yau, Manchester Metropolitan University:
Ulcerative Colitis
Inflammatory Bowel Disease
Exercise
Gastric emptying rate
Inflammatory markers
Gastrointestinal integrity
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes