Primary Objective:To assess the effect of a 12-week moderate-vigorous intensity exercise intervention in fatigued IBD patients with quiescent disease on fatigue and health-related quality of life (HRQoL) (short term, measured at 3 months).Secondary…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in fatigue and quality of life after 12-weeks physical exercise in the
intervention group compared to the control group. (short term, after 3 months)
Fatigue complaints will be measured with the inflammatory bowel disease fatigue
self-assessment scale (IBD-F) and quality of life will be measured with the
IBD-questionnaire (IBDQ).
Secondary outcome
• Long-term changes in fatigue and quality of life as measured after 6- and
12-months using the IBD-F and IBDQ questionnaires in the intervention group
compared to the control group;
• Changes in cardiorespiratory fitness and muscular strength of patients in the
intervention group after 3 months (post-intervention) assessed using CPET
(including maximum power and VO2max) and strength measurements using 1-RM;
• Change in body composition in the intervention group after 3 months
(post-intervention): body fat percentage measured using skinfold techniques and
BMI;
• Change in work productivity and activity impairment using the work
productivity cost questionnaire in the intervention group compared to the
control group;
• Disease activity measured by faecal calprotectin, exacerbation rate and
step-up therapy rate in both the intervention- and control group;
• Self-reported differences in sleep quality in the intervention group compared
to the control group, using the Pittsburgh Sleep Quality Index (PSQI);
• Differences in Anxiety and depression symptoms in the intervention group
compared to the control group, measured using the Hospital Anxiety and
Depression Scale (HADS) questionnaire;
• Economic evaluation of the intervention using a cost-utility analysis from a
societal perspective including intervention costs, medical consumption costs,
non-medical patient 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
designated EQ-5D-5L questionnaire;
• Exploratory: differences in the immunological profiles, microbiome diversity
and composition using 16SRNA sequencing and concentration of targeted
metabolites (short-chain fatty acids and tryptophan metabolites).
Background summary
Fatigue significantly impacts the quality of life (QoL) of patients with
inflammatory bowel disease (IBD) and is observed in 40% of patients with
quiescent disease. Specific treatment strategies are currently lacking.
Physical exercise might be an effective complementary treatment for fatigue, as
our previous pilot-study has demonstrated a benificial effect on fatigue and
QoL in IBD-patients. However trials with more evidence, such as a randomized
controlled trial, on the potential beneficial effect of physical exercise on
IBD-related fatigue is needed. Additionally, the long-term effects and
cost-effectivity of such intervention has not been determined before.
Study objective
Primary Objective:
To assess the effect of a 12-week moderate-vigorous intensity exercise
intervention in fatigued IBD patients with quiescent disease on fatigue and
health-related quality of life (HRQoL) (short term, measured at 3 months).
Secondary Objectives:
• To assess the effect of a 12-week moderate-vigorous intensity exercise
intervention in fatigued IBD patients with quiescent disease on;
- Fatigue and HRQoL (long term, measured at 6 and 12 months);
- The physical fitness of patients including body composition,
cardiorespiratory fitness and muscle strength;
- Work productivity and activity impairment;
- Disease activity;
- Self-reported sleep quality;
- Anxiety and depression symptoms;
- Furthermore, exploratory objectives include the effect of the intervention on
immunological profiles, microbiome diversity and composition and gut-derived
targeted metabolites (short-chain fatty acids and tryptophan metabolites)
• To assess the cost-effectiveness of a 12-week moderate-vigorous intensity
exercise intervention in fatigued IBD patients
Study design
A multicentre parallel randomized controlled trial will be executed. After
randomization, the study period covers a total of 12 months, including an
intervention duration of 3 months and subsequently 9 months of a follow-up
period to assess the long-term effects.
Intervention
A 12-week exercise program consisting of three times per week 1-hour sessions,
including 30-minutes aerobic- and 30-minutes progressive resistance training at
personalised intensity based on cardiopulmonary exercise test (CPET) and
one-repetition maximum (1-RM). The training sessions will be performed in
groups of 10 participants under supervision of a sports physiotherapist.
Study burden and risks
It is expected patients in the intervention group will benefit from the program
with improvement of their fatigue complaints and quality of life. Also, those
patients will be given the opportunity to participate in a supervised exercise
program free of charge. The risk of sports injuries is limited with adjustment
of intensity of exercise to each individual and supervision of a sports
physiotherapist. Regarding the burden for patients, they will have to fill in
multiple questionnaires four times over a period of 12 months, at baseline and
after the intervention blood and stool samples are needed and patients will
have to perform a CPET twice. The control group will not benefit directly from
this study. Completing multiple questionnaires four times over the same period
of 12 months as well as blood and stool samples twice in the study period will
be the presumed burden. No risks are associated with participation in the
control group
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
- >= 1 year diagnosis of IBD (including Crohn*s disease, ulcerative colitis and
IBD-unclassified) based on a combination of clinical, endoscopic, histologic
and radiologic internationally accepted criteria;
- Severe fatigue complaints >3 months 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);
- Patient is aged between 18 and 67 years
Exclusion criteria
- Intensive sport activities more than once a week / >90 minutes in the past
year.
- Past surgery within 6 months before or planned surgery 12 months after the
screening visit
- Comorbidities that could be confounders for fatigue; (such as severe
cardiorespitory disease, active malignancy, post-COVID or treatment for a
psychiatric disorder)
-Comorbidities that prevent safe participation in the exercise
program/cardiorespiratory fitness test (including cardiorespitory diseases,
BMI>=35, physical disabillities that compromise exercise performances).
- Pregnant at the moment of the screening visit or planning pregnancy within 12
months after the screening.
- Participation in another medical research.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81794.091.22 |