Skip to main content
Clinical Trials/NCT04143490
NCT04143490
Suspended
Not Applicable

The Effects of Exercise Intensity on Gastrointestinal Function and Inflammatory Markers in Patients With Ulcerative Colitis

Manchester Metropolitan University1 site in 1 country24 target enrollmentNovember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ulcerative Colitis
Sponsor
Manchester Metropolitan University
Enrollment
24
Locations
1
Primary Endpoint
Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones
Status
Suspended
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2019
End Date
December 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adora Yau

Lecturer

Manchester Metropolitan University

Eligibility 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)

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
  • Sedentary or not regularly physically active (determined via verbal discussion)
  • For healthy controls;
  • History of disease (as assessed by standard medical screening questionnaire)

Outcomes

Primary Outcomes

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

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

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

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

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

Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers

Time Frame: 4.5 hours

Response of plasma lipopolysaccharide

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

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 Outcomes

  • Disparity of subjective exertion and objective cardiorespiratory parameters(Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes)
  • Disparity of subjective exertion and objective heart rate(Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes)
  • Disparity of subjective exertion and oxygen pulse(Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes)
  • Incidence and severity of gastrointestinal symptoms(Immediately post-exercise bout and 3 hours post exercise.)
  • Heart rate response(Every 5 minutes during 60 minute cycle)
  • Disparity of subjective exertion and breathing frequency(Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes)
  • Disparity of subjective exertion and ventilatory efficiency(Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes)
  • Disparity of subjective exertion and respiratory exchange ratio(Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes)
  • Subjective physical activity levels(Prior to experimental trial)
  • Attitudes and beliefs towards physical activity(Prior to experimental trial)
  • Subjective health related quality of life: RAND 36-Item Short Form Health Survey (SF-36)(Prior to experimental trial)

Study Sites (1)

Loading locations...

Similar Trials