Clinical trial NCT04143490: Effects of Exercise in Patients With Ulcerative Colitis
Official title: The Effects of Exercise Intensity on Gastrointestinal Function and Inflammatory Markers in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Keywords: Ulcerative Colitis
Inflammatory Bowel Disease
Exercise
Gastric emptying rate
Inflammatory markers
Gastrointestinal integrity
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2019-10-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single experimental trial with a UC patient group and an age and gender matched healthy control group
Primary purpose: BASIC_SCIENCE

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.

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)
* 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)

Primary outcomes:
measure: Change in inflammatory markers or hormones
timeFrame: 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
measure: Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones
timeFrame: 4.5 hours
measure: Change in intestinal epithelial damage and permeability markers
timeFrame: 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
measure: Area under the circulating concentration versus time curve (AUC) of intestinal epithelial damage and permeability markers
timeFrame: 4.5 hours
measure: Change in exercise induced endotoxaemia markers
timeFrame: 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
measure: Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers
timeFrame: 4.5 hours
measure: Gastric emptying rate half time and time of maximal emptying rate
timeFrame: 2 hours after ingestion of drink
measure: Change in ratio of 13C/12C in breath samples
timeFrame: 9 breath samples collected at baseline, then every 15 minutes after ingestion for 2 hours
Secondary outcomes:
measure: Incidence and severity of gastrointestinal symptoms
timeFrame: Immediately post-exercise bout and 3 hours post exercise.
measure: Heart rate response
timeFrame: Every 5 minutes during 60 minute cycle
measure: Disparity of subjective exertion and objective cardiorespiratory parameters
timeFrame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
measure: Disparity of subjective exertion and objective heart rate
timeFrame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
measure: Disparity of subjective exertion and breathing frequency
timeFrame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
measure: Disparity of subjective exertion and oxygen pulse
timeFrame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
measure: Disparity of subjective exertion and respiratory exchange ratio
timeFrame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
measure: Disparity of subjective exertion and ventilatory efficiency
timeFrame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
measure: Subjective physical activity levels
timeFrame: Prior to experimental trial
measure: Attitudes and beliefs towards physical activity
timeFrame: Prior to experimental trial
measure: Subjective health related quality of life: RAND 36-Item Short Form Health Survey (SF-36)
timeFrame: Prior to experimental trial
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Metropolitan University
state: Greater Manchester
Study officials:
affiliation: Manchester Metropolitan University
name: Gethin H Evans, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester Metropolitan University
name: Adora MW Yau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: John McLaughlin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: