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

May 8, 2023 updated by: Gofflot Amandine, University of Liege
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Université de Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Endurance training group
Other: Endurance training
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.
Experimental: Resistance training group
Other: Resistance training
Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progressive effort test on bicycle ergometer (VO2 max)
Time Frame: day 1
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
day 1
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)
through study completion, an average of 40 weeks
Progressive effort test on bicycle ergometer (Heart rate)
Time Frame: day 1
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)
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.
through study completion, an average of 40 weeks
Progressive effort test on bicycle ergometer (Power)
Time Frame: day 1
This test allows to measure maximum aerobic power in Watt.
day 1
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.
through study completion, an average of 40 weeks
Maximum force test (N/m)
Time Frame: Day 1
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)
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.
through study completion, an average of 40 weeks
Blood sample
Time Frame: Day 1
This type of tests includes biological monitoring to obtain information on biological parameters.
Day 1
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.
through study completion, an average of 40 weeks
Saddle analysis
Time Frame: Day 1
This type of tests includes biological monitoring to obtain information on biological parameters.
Day 1
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.
through study completion, an average of 40 weeks
IBD-F
Time Frame: Week 1
Participants will complete a questionnaire on fatigue perceived.
Week 1
IBD-F
Time Frame: Week 10
Participants will complete a questionnaire on fatigue perceived.
Week 10
IBD-F
Time Frame: Week 20
Participants will complete a questionnaire on fatigue perceived.
Week 20
Godin Leisure Time exercise questionnaire
Time Frame: Week 1
Participants will complete a questionnaire on the level of physical activity
Week 1
Metabolic Equivalent Task questionnaire
Time Frame: Week 1
Participants will complete a questionnaire on the level of inactivity
Week 1
Metabolic Equivalent Task questionnaire
Time Frame: Week 10
Participants will complete a questionnaire on the level of inactivity
Week 10
Metabolic Equivalent Task questionnaire
Time Frame: Week 20
Participants will complete a questionnaire on the level of inactivity
Week 20
Short Food Frequency Questionnaire
Time Frame: Week 1
Participants will complete a questionnaire on their dietary habits
Week 1
Short Food Frequency Questionnaire
Time Frame: Week 10
Participants will complete a questionnaire on their dietary habits
Week 10
Short Food Frequency Questionnaire
Time Frame: Week 20
Participants will complete a questionnaire on their dietary habits
Week 20
EQ5D questionnaire
Time Frame: Week 1
Participants will complete a questionnaire on their level of health
Week 1
EQ5D questionnaire
Time Frame: Week 10
Participants will complete a questionnaire on their level of health
Week 10
EQ5D questionnaire
Time Frame: Week 20
Participants will complete a questionnaire on their level of health
Week 20
Short health scale questionnaire
Time Frame: Week 1
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Week 1
Short health scale questionnaire
Time Frame: Week 10
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Week 10
Short health scale questionnaire
Time Frame: Week 20
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20202021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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