search
Back to results

The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease (ENERGIZE-IBD)

Primary Purpose

Inflammatory Bowel Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Exercise intervention
Usual care
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Fatigue, Exercise, Quality of life, IBD

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥1 year diagnosis of IBD, including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria; Chronic fatigue complaints for at least 3 months; Severe fatigue complaints as confirmed with a score of ≥11 on section I of the inflammatory bowel disease fatigue self-assessment scale (IBD-F); Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for Crohn's disease patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with ulcerative colitis or IBD-unclassified; Faecal calprotectin <100 μg/g; Stable medication for at least 3 months before screening visit; Patient is able and willing to provide written informed consent; Patient is able/commitment to make a time investment to complete the intervention program (one hour training 3x/week during 12 weeks) or, after randomisation, willing to participate in the control group; Patient is aged between 18 and 60 years. Exclusion Criteria: Performing moderate-vigorous intensity exercise (i.e. swimming, running, cycling) more than once and/or >90 minutes per week in the past 3 months; Surgery within the past 6 months or planned surgery within 12 months after the screening visit; Participation in another intervention study; Pregnant at the moment of the screening visit or planning pregnancy within 12 months after the screening; Confirmed diagnosis of other causes of fatigue complaints, such as thyroid dysfunction, liver or renal failure, anaemia, folate-, iron-, vitamin B12- or D deficiency. Comorbidities that could be confounders for fatigue, such as Chronic obstructive pulmonary disease (COPD), heart failure, active malignancy, long/Post-COVID and patients under treatment for a psychiatric disorder (i.e. depression/anxiety) Comorbidities that prevent safe participation in the exercise program/cardiorespiratory fitness test including; Very high risk of cardiovascular disease Uncontrolled diabetes mellitus with HbA1c > 65 mmol/l. Cardiovascular disease (i.e. acute myocardial infarct, unstable angina, uncontrolled arrhythmias, aortic stenosis, stenotic valvular heart disease, untreated arterial hypertension (>200 mmHg systolic, >120 mmHg diastolic)) Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, thyrotoxicosis) Uncontrolled asthma Pulmonary oedema Significant pulmonary hypertension Acute pulmonary embolus or pulmonary infarction Room air desaturation at rest <85% (exercise with supplemental O2) Respiratory failure Electrolyte abnormalities (sodium, potassium, calcium, magnesium) Mental impairment leading to inability to cooperate Orthopaedic impairment that compromise exercise performance BMI ≥35

Sites / Locations

  • Rijnstate Hospital
  • Radboud Univeristy Medical Center
  • Jeroen Bosch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention (exercise) group

Control group

Arm Description

The patients in the intervention group will follow a personalised and intensive exercise program.

The patients in the control group will receive usual care.

Outcomes

Primary Outcome Measures

Change in fatigue (IBD-F), post-intervention
Mean change in fatigue, measured with the inflammatory bowel disease fatigue self-assessment scale (IBD-F) 0-140 with higher scores indicating worse fatigue, in the intervention group compared to the control group.
Change in quality of life (IBDQ), post-intervention
Mean change in quality of life, measured with the inflammatory bowel disease questionnaire (IBDQ) 32-224 with higher scores representing better quality of life, in the intervention group compared to the control group.

Secondary Outcome Measures

Long-term change in fatigue (IBD-F)
Mean change in fatigue, as measured after 6- and 12-months using the IBD-F, in the intervention group compared to the control group
Long-term change in quality of life (IBDQ)
Mean change in quality of life, as measured after 6- and 12-months using the IBDQ, in the intervention group compared to the control group
Change in cardiorespiratory fitness (maximum oxygen uptake)
Change in cardiorespiratory fitness (maximum oxygen uptake) of patients in the intervention group, assessed using Cardiopulmonary Exercise Testing (CPET).
Change in cardiorespiratory fitness (maximum power)
Change in cardiorespiratory fitness (maximum power) of patients in the intervention group, assessed using Cardiopulmonary Exercise Testing (CPET).
Change in muscular strength
Change in muscular strength of patients in the intervention group, assessed using one-repetition maximum (1-RM)
Change in body composition (BMI)
Change in body composition in the intervention group, as determined by body mass index (BMI).
Change in body composition (body fat percentage)
Change in body composition in the intervention group, as determined by body fat percentage measured using skinfold techniques
Change in work absenteeism and presenteeism
Change in work absenteeism and presenteeism in the intervention group compared to the control group, as measured by the Productivity Cost Questionnaire (iPCQ)
Disease activity (FCP)
Disease activity measured by change in faecal calprotectin (FCP), in both the intervention- and control group
Disease activity (step-up therapy)
Disease activity measured by step-up therapy rate in both the intervention- and control group
Disease activity (exacerbation rate)
Disease activity measured by exacerbation rate in both the intervention- and control group
Change in sleep quality
Self-reported differences in sleep quality in the intervention group compared to the control group, using the Pittsburgh Sleep Quality Index (PSQI), 0-21 with higher scores indicating worse sleep quality.
Change in anxiety and depression symptoms
Mean change in anxiety and depression symptoms in the intervention group compared to the control group, measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire, each subscale 0-21 higher scores indicating worse symptoms
Targeted cost-utility analysis
Targeted economic evaluation of the intervention using a targeted cost-utility analysis from a societal perspective including intervention costs, medical consumption costs and productivity loss. Effectiveness of the intervention will be determined using the mean Difference of quality adjusted life years (QALYs) between de intervention and control group, based on the designated EQ-5D-5L questionnaire.
Exploratory outcome measurements (immunological profiles)
Differences in the immunological profiles (i.e. pro- and anti-inflammatory cytokines and soluble receptors, such as IL-10, IL-6, IFN-ɣ) in the intervention group compared to the control group
Exploratory outcome measurements (gut microbiota)
Differences in the gut microbiota diversity and composition in the intervention group compared to the control group using 16SrRNA sequencing.
Exploratory outcome measurements (biogenic amines)
Differences in the concentration of biogenic amines in the intervention group compared to the control group.

Full Information

First Posted
October 24, 2022
Last Updated
December 19, 2022
Sponsor
Rijnstate Hospital
Collaborators
Dutch Digestive Diseases Foundation, Sport Medisch Centrum Papendal, FormUpgrade, Arnhem, Sport Medisch Centrum, Jeroen Bosch Ziekenhuis
search

1. Study Identification

Unique Protocol Identification Number
NCT05657197
Brief Title
The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease
Acronym
ENERGIZE-IBD
Official Title
ENERGIZE IBD - The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 25, 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
Dutch Digestive Diseases Foundation, Sport Medisch Centrum Papendal, FormUpgrade, Arnhem, Sport Medisch Centrum, Jeroen Bosch Ziekenhuis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In patients with inflammatory bowel diseases (IBD), characterized by relapsing intestinal inflammation, chronic fatigue is a burdensome and highly prevalent symptom. The aetiology is thought to be multifactorial, including complex interactions of psychological and physical factors such as immunological profiles and gut microbiota. Unfortunately, specific treatment strategies are currently lacking. Since fatigued patients have an impaired physical fitness and are less physically active than patients without fatigue, it is hypothesised that physical exercise might be an effective complementary treatment for patients with IBD suffering from fatigue. During a previous pilot cohort study, significant improvements in fatigue complaints and quality of life were observed following a personalised and intensive exercise program. In this study, a multicenter randomized controlled trial will be performed to further investigate this assumed beneficial effect of intensive physical exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Fatigue, Exercise, Quality of life, IBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Multicentre parallel randomised controlled trial
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (exercise) group
Arm Type
Experimental
Arm Description
The patients in the intervention group will follow a personalised and intensive exercise program.
Arm Title
Control group
Arm Type
Other
Arm Description
The patients in the control group will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Exercise intervention
Intervention Description
A 12-week exercise program consisting of three times per week 1-hour sessions, including 30-minutes aerobic- and 30-minutes progressive resistance training. The intensity of training will be adjusted to each individual, based on a cardiopulmonary exercise test. Training sessions will be performed in groups of 10 participants under supervision of a sports physical therapist.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care, including general advice concerning chronic fatigue.
Primary Outcome Measure Information:
Title
Change in fatigue (IBD-F), post-intervention
Description
Mean change in fatigue, measured with the inflammatory bowel disease fatigue self-assessment scale (IBD-F) 0-140 with higher scores indicating worse fatigue, in the intervention group compared to the control group.
Time Frame
3 months (post-intervention)
Title
Change in quality of life (IBDQ), post-intervention
Description
Mean change in quality of life, measured with the inflammatory bowel disease questionnaire (IBDQ) 32-224 with higher scores representing better quality of life, in the intervention group compared to the control group.
Time Frame
3 months (post-intervention)
Secondary Outcome Measure Information:
Title
Long-term change in fatigue (IBD-F)
Description
Mean change in fatigue, as measured after 6- and 12-months using the IBD-F, in the intervention group compared to the control group
Time Frame
6- and 12-months
Title
Long-term change in quality of life (IBDQ)
Description
Mean change in quality of life, as measured after 6- and 12-months using the IBDQ, in the intervention group compared to the control group
Time Frame
6- and 12-months
Title
Change in cardiorespiratory fitness (maximum oxygen uptake)
Description
Change in cardiorespiratory fitness (maximum oxygen uptake) of patients in the intervention group, assessed using Cardiopulmonary Exercise Testing (CPET).
Time Frame
3 months (post-intervention)
Title
Change in cardiorespiratory fitness (maximum power)
Description
Change in cardiorespiratory fitness (maximum power) of patients in the intervention group, assessed using Cardiopulmonary Exercise Testing (CPET).
Time Frame
3 months (post-intervention)
Title
Change in muscular strength
Description
Change in muscular strength of patients in the intervention group, assessed using one-repetition maximum (1-RM)
Time Frame
3 months (post-intervention)
Title
Change in body composition (BMI)
Description
Change in body composition in the intervention group, as determined by body mass index (BMI).
Time Frame
3 months (post-intervention)
Title
Change in body composition (body fat percentage)
Description
Change in body composition in the intervention group, as determined by body fat percentage measured using skinfold techniques
Time Frame
3 months (post-intervention)
Title
Change in work absenteeism and presenteeism
Description
Change in work absenteeism and presenteeism in the intervention group compared to the control group, as measured by the Productivity Cost Questionnaire (iPCQ)
Time Frame
T= 3-, 6-, 9-, and 12-months
Title
Disease activity (FCP)
Description
Disease activity measured by change in faecal calprotectin (FCP), in both the intervention- and control group
Time Frame
T= 3-, 6-, 9-, and 12-months
Title
Disease activity (step-up therapy)
Description
Disease activity measured by step-up therapy rate in both the intervention- and control group
Time Frame
T= 3-, 6-, 9-, and 12-months
Title
Disease activity (exacerbation rate)
Description
Disease activity measured by exacerbation rate in both the intervention- and control group
Time Frame
T= 3-, 6-, 9-, and 12-months
Title
Change in sleep quality
Description
Self-reported differences in sleep quality in the intervention group compared to the control group, using the Pittsburgh Sleep Quality Index (PSQI), 0-21 with higher scores indicating worse sleep quality.
Time Frame
T= 3-, 6-, 9-, and 12-months
Title
Change in anxiety and depression symptoms
Description
Mean change in anxiety and depression symptoms in the intervention group compared to the control group, measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire, each subscale 0-21 higher scores indicating worse symptoms
Time Frame
T= 3-, 6-, 9-, and 12-months
Title
Targeted cost-utility analysis
Description
Targeted economic evaluation of the intervention using a targeted cost-utility analysis from a societal perspective including intervention costs, medical consumption costs and productivity loss. Effectiveness of the intervention will be determined using the mean Difference of quality adjusted life years (QALYs) between de intervention and control group, based on the designated EQ-5D-5L questionnaire.
Time Frame
12 months
Title
Exploratory outcome measurements (immunological profiles)
Description
Differences in the immunological profiles (i.e. pro- and anti-inflammatory cytokines and soluble receptors, such as IL-10, IL-6, IFN-ɣ) in the intervention group compared to the control group
Time Frame
3 months (post-intervention)
Title
Exploratory outcome measurements (gut microbiota)
Description
Differences in the gut microbiota diversity and composition in the intervention group compared to the control group using 16SrRNA sequencing.
Time Frame
3 months (post-intervention)
Title
Exploratory outcome measurements (biogenic amines)
Description
Differences in the concentration of biogenic amines in the intervention group compared to the control group.
Time Frame
3 months (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥1 year diagnosis of IBD, including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria; Chronic fatigue complaints for at least 3 months; Severe fatigue complaints as confirmed with a score of ≥11 on section I of the inflammatory bowel disease fatigue self-assessment scale (IBD-F); Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for Crohn's disease patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with ulcerative colitis or IBD-unclassified; Faecal calprotectin <100 μg/g; Stable medication for at least 3 months before screening visit; Patient is able and willing to provide written informed consent; Patient is able/commitment to make a time investment to complete the intervention program (one hour training 3x/week during 12 weeks) or, after randomisation, willing to participate in the control group; Patient is aged between 18 and 60 years. Exclusion Criteria: Performing moderate-vigorous intensity exercise (i.e. swimming, running, cycling) more than once and/or >90 minutes per week in the past 3 months; Surgery within the past 6 months or planned surgery within 12 months after the screening visit; Participation in another intervention study; Pregnant at the moment of the screening visit or planning pregnancy within 12 months after the screening; Confirmed diagnosis of other causes of fatigue complaints, such as thyroid dysfunction, liver or renal failure, anaemia, folate-, iron-, vitamin B12- or D deficiency. Comorbidities that could be confounders for fatigue, such as Chronic obstructive pulmonary disease (COPD), heart failure, active malignancy, long/Post-COVID and patients under treatment for a psychiatric disorder (i.e. depression/anxiety) Comorbidities that prevent safe participation in the exercise program/cardiorespiratory fitness test including; Very high risk of cardiovascular disease Uncontrolled diabetes mellitus with HbA1c > 65 mmol/l. Cardiovascular disease (i.e. acute myocardial infarct, unstable angina, uncontrolled arrhythmias, aortic stenosis, stenotic valvular heart disease, untreated arterial hypertension (>200 mmHg systolic, >120 mmHg diastolic)) Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, thyrotoxicosis) Uncontrolled asthma Pulmonary oedema Significant pulmonary hypertension Acute pulmonary embolus or pulmonary infarction Room air desaturation at rest <85% (exercise with supplemental O2) Respiratory failure Electrolyte abnormalities (sodium, potassium, calcium, magnesium) Mental impairment leading to inability to cooperate Orthopaedic impairment that compromise exercise performance BMI ≥35
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J. van Berlo, MSc
Phone
088 - 005 6800
Email
jvanberlo@rijnstate.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. M.J.M. Groenen, MD, PhD
Organizational Affiliation
Gastroenterology department, Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. van Berlo, MSc
Phone
088 - 005 6800
Email
jvanberlo@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Dr. M.J.M. Groenen, MD, PhD
Facility Name
Radboud Univeristy Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Jeroen Bosch Hospital
City
Den Bosch
State/Province
S' Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32239380
Citation
van Erp LW, Roosenboom B, Komdeur P, Dijkstra-Heida W, Wisse J, Horjus Talabur Horje CS, Liem CS, van Cingel REH, Wahab PJ, Groenen MJM. Improvement of Fatigue and Quality of Life in Patients with Quiescent Inflammatory Bowel Disease Following a Personalized Exercise Program. Dig Dis Sci. 2021 Feb;66(2):597-604. doi: 10.1007/s10620-020-06222-5. Epub 2020 Apr 1.
Results Reference
background

Learn more about this trial

The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease

We'll reach out to this number within 24 hrs