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

NCT04589338 | Completed

• 1 other identifier: 20202021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Exercise Therapy

Outcome Measures

Primary Outcomes (28)

• Progressive effort test on bicycle ergometer (VO2 max)

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

  day 1

• Progressive effort test on bicycle ergometer (VO2 max)

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

  through study completion, an average of 40 weeks

• Progressive effort test on bicycle ergometer (Heart rate)

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

  day 1

• Progressive effort test on bicycle ergometer (Heart rate)

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

  through study completion, an average of 40 weeks

• Progressive effort test on bicycle ergometer (Power)

  This test allows to measure maximum aerobic power in Watt.

  day 1

• Progressive effort test on bicycle ergometer (Power)

  This test allows to measure maximum aerobic power in Watt.

  through study completion, an average of 40 weeks

• Maximum force test (N/m)

  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.

  Day 1

• Maximum force test (N/m)

  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.

  through study completion, an average of 40 weeks

• Blood sample

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

  Day 1

• Blood sample

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

  through study completion, an average of 40 weeks

• Saddle analysis

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

  Day 1

• Saddle analysis

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

  through study completion, an average of 40 weeks

• IBD-F

  Participants will complete a questionnaire on fatigue perceived.

  Week 1

• IBD-F

  Participants will complete a questionnaire on fatigue perceived.

  Week 10

• IBD-F

  Participants will complete a questionnaire on fatigue perceived.

  Week 20

• Godin Leisure Time exercise questionnaire

  Participants will complete a questionnaire on the level of physical activity

  Week 1

• Metabolic Equivalent Task questionnaire

  Participants will complete a questionnaire on the level of inactivity

  Week 1

• Metabolic Equivalent Task questionnaire

  Participants will complete a questionnaire on the level of inactivity

  Week 10

• Metabolic Equivalent Task questionnaire

  Participants will complete a questionnaire on the level of inactivity

  Week 20

• Short Food Frequency Questionnaire

  Participants will complete a questionnaire on their dietary habits

  Week 1

• Short Food Frequency Questionnaire

  Participants will complete a questionnaire on their dietary habits

  Week 10

• Short Food Frequency Questionnaire

  Participants will complete a questionnaire on their dietary habits

  Week 20

• EQ5D questionnaire

  Participants will complete a questionnaire on their level of health

  Week 1

• EQ5D questionnaire

  Participants will complete a questionnaire on their level of health

  Week 10

• EQ5D questionnaire

  Participants will complete a questionnaire on their level of health

  Week 20

• Short health scale questionnaire

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

  Week 1

• Short health scale questionnaire

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

  Week 10

• Short health scale questionnaire

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

  Week 20

Study Arms (3)

Endurance training group

EXPERIMENTAL

Other: Endurance training

Resistance training group

EXPERIMENTAL

Other: Resistance training

Control group

NO INTERVENTION

Interventions

Endurance training OTHER

This group will perform aerobic type exercises. Initially, patients will perform continuous exercises of progressive intensity in order to adapt to this kind of effort. Next, we will introduce interval exercises.

Endurance training group

Resistance training OTHER

Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.

Resistance training group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Université de Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Endurance Training; Resistance Training

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 19, 2020
• Study Start: January 5, 2021
• Primary Completion: December 15, 2022
• Study Completion: February 7, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

BE (1)