Primary Objective: - To assess the effectiveness of a sports program on fatigue and quality of life in IBD patients with quiescent disease and chronic fatigue.Secondary Objectives: - To assess the influence of a sport program on the physical fitness…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in fatigue complaints measured with the CIS-F checklist and in quality
of life measured with the IBD-Q checklist.
Secondary outcome
Physical fitness including cardiorespiratory fitness, muscle strength and body
composition.
Background summary
Ulcerative colitis (UC) and Crohn*s disease (CD) are Inflammatory Bowel
Diseases (IBD). IBD is a heterogeneous group of diseases regarding clinical
presentation, disease course and treatment response. The incidence is
increasing in the past decades and disease burden is substantial due to the
chronic nature and generally young age at onset of disease. Pathogenesis is
complex and multifactorial, based on interactions between genetic and
environmental factors, gut microbiota and the immune system, leading to
intestinal inflammation.
Besides diarrhoea, rectal blood loss, abdominal pain and weight loss, fatigue
is one of the main symptoms of IBD and is frequently observed in patients in
both active and quiescent disease. It is defined as a sense of continuing
tiredness, with periods of sudden and overwhelming lack of energy or a feeling
of exhaustion that is not relieved or fully relieved following rest or sleep
and strongly influences the quality of life in these patients. 1 (Ream et
al.Fatigue: a concept analysis. Int J Nurs Stud 1996) In the Netherlands, 41%
patients with quiescent disease complain of severe fatigue. 2 (Minderhoud et al
2007 Crohn*s disease, fatigue and Infliximab )
Treatment strategies in patients with an inflammatory bowel disease consist of
a wide range of pharmacological options (e.g. steroids, thiopurines,
biologicals), nutrition modification, abstinence of smoking and in a last
resort surgery. Despite solution-focused psychological interventions showed to
be effective in reducing fatigue in the majority of patients, there is still a
group of patients suffering from serious fatigue even in remission with a lower
quality of life compared to healthy persons. 3 (Vogelaar et al, 2015 Physical
fitness and physical activity in fatigued and non-fatigued inflammatory bowel
disease patients) There is also a group which reported insufficient fatigue
management in daily practice.
In several chronic diseases including heart failure, depression and COPD,
fatigue and quality of life (QoL) improved due to physical activity as a
complementary treatment. Therefore structured exercise training has been
proposed as a useful adjunctive therapy for IBD patients by improving
psychological health, reducing fatigue and promoting gains in physical
strength. 4 (Tew et al Feasibility of HIT and MIT in adults with inactive or
mildly active Crohn*s disease 2017) The purpose of this study is to assess the
effectiveness of a structural sports program on fatigue and QoL in IBD patients
with quiescent disease and chronic fatigue.
Study objective
Primary Objective:
- To assess the effectiveness of a sports program on fatigue and quality of
life in IBD patients with quiescent disease and chronic fatigue.
Secondary Objectives:
- To assess the influence of a sport program on the physical fitness including
cardiorespiratory fitness, muscle strength and body composition.
Study design
The study will be a longitudinal, prospective, cohort study. It is a pilot
study that will be performed at the department Sport Medical Center Papendal
with patients from the department of Gastro-enterology and Hepatology of the
Rijnstate Hospital. The study period covers to the utmost one year.
Study burden and risks
The benefit for the study population is that they have the opportunity to sport
for free at the Sport Center Formupgrade in Arnhem. The risk for sport injuries
is restricted because the sportactivities are under supervision of a physician.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
- The diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria in the past.
- Both patients with Crohn*s disease, Ulcerative colitis and IBD-unclassified in remission (SES-CD 0-2 and Mayo score 0).
- The faecal calprotectin must be below 50.
- Fatigue level on the Checklist Individual Strenght fatigue must be above or equal to 35 (CIS-F score *35)
- Stable medication for at least 4 weeks before the screening visit.
- Patients must be able and willing to provide written informed consent.
- Patients between the age of 25 and 60 years, both men and women.
Exclusion criteria
- IBD diagnosis within one year before the screening visit.
- Intensive sport activities more than once a week in the past year.
- Operation within 6 months before or 3 months after the screening visit
- Coexistent chronic diseases for example heart failure, COPD an malignancies.
- Pregnant at the moment of the screening visit or planning pregnancy within 3 months after the screening.
- Participation in another medical research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63369.091.17 |