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Clinical Trials/NCT04589338
NCT04589338
Completed
N/A

Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease

University of Liege1 site in 1 country24 target enrollmentJanuary 5, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Inflammatory Bowel Diseases
Sponsor
University of Liege
Enrollment
24
Locations
1
Primary Endpoint
Short health scale questionnaire
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a prospective interventional study. The investigators will include patients in clinical remission who are on stable treatment. These IBD patients will be followed to analyze the effects of physical activity on their inflammatory disease. Different exercises will be offered to two separate groups of randomly distributed patients: the first group will perform muscle building exercises while the other group will be offered aerobic exercises.There will also be a control group that does not initially benefit from a specific physical activity program. However, this group will be integrated into one of the other two groups after the 10-week follow-up. All three groups will perform the same baseline tests. These will be of different types: physical tests, biological tests and quality of life questionnaires.

Registry
clinicaltrials.gov
Start Date
January 5, 2021
End Date
February 7, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gofflot Amandine

Principal Investigator

University of Liege

Eligibility Criteria

Inclusion Criteria

  • Patients in remission defined by a Harvey Bradshaw Index 5 in Crohn's disease (CD) and a clinical Mayo 3 with no sub-score \>1 in ulcerative colitis (RCUH) with stable treatment, without corticosteroid for 4 months.
  • Patients accepting the study protocol

Exclusion Criteria

  • Patients suffering from other pathologies (at the level of the digestive system, the cardiovascular system, as well as the musculoskeletal system: recent knee plasty, recent knee fractures, etc.), which can interfere with planned tests and activity programs.
  • Patients with more than 3 hours of sports activity per week
  • Pregnant, pregnant or nursing patients

Outcomes

Primary Outcomes

Short health scale questionnaire

Time Frame: Week 20

Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease

EQ5D questionnaire

Time Frame: Week 20

Participants will complete a questionnaire on their level of health

Short Food Frequency Questionnaire

Time Frame: Week 20

Participants will complete a questionnaire on their dietary habits

Progressive effort test on bicycle ergometer (VO2 max)

Time Frame: through study completion, an average of 40 weeks

This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)

Progressive effort test on bicycle ergometer (Power)

Time Frame: through study completion, an average of 40 weeks

This test allows to measure maximum aerobic power in Watt.

Blood sample

Time Frame: through study completion, an average of 40 weeks

This type of tests includes biological monitoring to obtain information on biological parameters.

Saddle analysis

Time Frame: through study completion, an average of 40 weeks

This type of tests includes biological monitoring to obtain information on biological parameters.

IBD-F

Time Frame: Week 20

Participants will complete a questionnaire on fatigue perceived.

Progressive effort test on bicycle ergometer (Heart rate)

Time Frame: through study completion, an average of 40 weeks

This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.

Maximum force test (N/m)

Time Frame: through study completion, an average of 40 weeks

This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.

Godin Leisure Time exercise questionnaire

Time Frame: Week 1

Participants will complete a questionnaire on the level of physical activity

Metabolic Equivalent Task questionnaire

Time Frame: Week 20

Participants will complete a questionnaire on the level of inactivity

Study Sites (1)

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