Effects of Exercise in Patients With Ulcerative Colitis

NCT ID: NCT04143490

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2025-12-31

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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

UC Patients

Patient group

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

60 minutes of continuous exercise at 65% VO2peak and drink ingestion

Healthy controls

Control group

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

60 minutes of continuous exercise at 65% VO2peak and drink ingestion

Interventions

Exercise

60 minutes of continuous exercise at 65% VO2peak and drink ingestion

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Manchester Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Adora Yau

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gethin H Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester Metropolitan University

Adora MW Yau, PhD

Role: PRINCIPAL_INVESTIGATOR

Manchester Metropolitan University

John McLaughlin, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Manchester Metropolitan University

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

Other Identifiers

ExerciseUC-2019

Identifier Type: -

Identifier Source: org_study_id