Effects of Exercise in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04143490
• Other study ID #: ExerciseUC-2019
• Status: Suspended
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Manchester Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Exercise
60 minutes of continuous exercise at 65% VO2peak and drink ingestion

Locations

Country	Name	City	State
United Kingdom	Manchester Metropolitan University	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester Metropolitan University	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inflammatory markers or hormones	Circulating concentrations of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2	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
Primary	Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones	Responses of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2	4.5 hours
Primary	Change in intestinal epithelial damage and permeability markers	Circulating concentrations of intestinal fatty acid binding protein and claudin-3	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
Primary	Area under the circulating concentration versus time curve (AUC) of intestinal epithelial damage and permeability markers	Responses of intestinal fatty acid binding protein and claudin-3	4.5 hours
Primary	Change in exercise induced endotoxaemia markers	Circulating concentrations of plasma lipopolysaccharide	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
Primary	Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers	Response of plasma lipopolysaccharide	4.5 hours
Primary	Gastric emptying rate half time and time of maximal emptying rate	Emptying rate of a commercially available sports drink from the stomach using the 13C breath test method	2 hours after ingestion of drink
Primary	Change in ratio of 13C/12C in breath samples	Gastric emptying profile of a commercially available sports drink from the stomach using the 13C breath test method	9 breath samples collected at baseline, then every 15 minutes after ingestion for 2 hours
Secondary	Incidence and severity of gastrointestinal symptoms	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.	Immediately post-exercise bout and 3 hours post exercise.
Secondary	Heart rate response	Heart rate telemetry	Every 5 minutes during 60 minute cycle
Secondary	Disparity of subjective exertion and objective cardiorespiratory parameters	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).	Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Secondary	Disparity of subjective exertion and objective heart rate	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	Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Secondary	Disparity of subjective exertion and breathing frequency	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	Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Secondary	Disparity of subjective exertion and oxygen pulse	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.	Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Secondary	Disparity of subjective exertion and respiratory exchange ratio	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.	Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Secondary	Disparity of subjective exertion and ventilatory efficiency	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).	Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Secondary	Subjective physical activity levels	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.	Prior to experimental trial
Secondary	Attitudes and beliefs towards physical activity	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.	Prior to experimental trial
Secondary	Subjective health related quality of life: RAND 36-Item Short Form Health Survey (SF-36)	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.	Prior to experimental trial