Management of fatigue in sicca syndromes.|
|- candidate number||13107|
|- NTR Number||NTR3514|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jul-2012|
|- Secondary IDs||DAA0701029 Dutch Arthritis Association (Reumafonds)|
|- Public Title||Management of fatigue in sicca syndromes.|
|- Scientific Title||Cognitive-behavioral therapy and exercise training to treat fatigue in Sjögren’s syndrome and non-Sjögren’s
sicca syndrome: A randomized controlled trial.|
|- hypothesis||Cognitive-behavioral therapy and exercise training will improve fatigue in Sjögren’s syndrome and non-Sjögren’s sicca syndrome.|
|- Healt Condition(s) or Problem(s) studied||Sjogrens Syndrome, Non-Sjögren's sicca syndrome|
|- Inclusion criteria||1. Patients ≥ 18 years with Sjögren's syndrome who fulfill the European criteria for classification (Vitali et al.,
2002). Patients in whom no other cause for dryness was found and who did not fulfill the European
classification criteria of Sjögren syndrome, are classified as non-Sjögren's sicca syndrome;|
2. A score ≥ 14 on the Multidimensional Fatigue Inventory (MFI);
3. No medication or stable use of regular medication during the intervention;
4. Motivated to participate in a cognitive-behavioural therapy combined with exercise training.
|- Exclusion criteria||1. Participation in other (recent) interventions which can possible effect fatigue (i.e. start of using antidepressants
during the last half year, or participating in a pharmacological trial);|
2. Use of prednisone >10mg per day;
4. Physical inability to participate in the intervention;
5. Severe psychopathology;
6. Illiteracy or difficulty to communicate in Dutch.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2014|
|- Target number of participants||144|
|- Interventions||Patients in the treatment group (n=48) receive a structured outpatient treatment program in groups setting of ten participants. Treatment consists of ten sessions within four months and one booster session three months after treatment completion, with every regular session starting with two hours of cognitive behavioral therapy, followed by one hour of exercise training. The patient’s partner (or other significant relation) will be invited by the patient to attend the sixth and eighth session. These sessions will focus on the consequences of fatigue for the social environment and the possible role of significant others in the reduction of fatigue. The treatment focuses on diminishing the daily cognitive, behavioral, emotional and social consequences of fatigue and accompanying symptoms. Every session, guided by a cognitive behavioral therapist, starts with discussion of the therapeutic program trained at home, then the specific topic of the session will be introduced and practiced with the other participants, and finally the training at home for the next session will be explained. The cognitive behavioral therapy will focus on realistic goal setting, a balanced daily activity program, cognitive restructuring techniques, and assertive social skills. The exercise training, led by physiotherapists, aims to gradually increase the level of physical fitness and flexibility and to let the patient get acquainted with physical exercises that bring joy or satisfaction. Each exercise session consists of two parts. Each session starts with discussion of the graded exercise therapy program that was trained at home. In this part, individualized per participant, participants learn how to gradually and safely increase their level of physical activity, under supervision of a physiotherapist. The second part of each session consists of an introduction to various types of physical activity (e.g. relaxation training, gymnastic exercises, strength and flexibility exercises, functional walking training). Aim of this part of the therapy is to perpetuate physical activity on the long term by learning the patients types of exercise that are pleasant or fulfills goals that bring satisfaction.
A waitinglist control group (n=48) will receive treatment after the treatment group completes the intervention.
A non-intention to treat group (n=48) does not want to participate in the treatment.
|- Primary outcome||Fatigue as assessed by the Multidimensional Fatigue Inventory (MFI).|
|- Secondary outcome||Secondary outcomes and mediator variables:|
1. Physical functioning (physical component summary, PCS of the SF-36);
2. Mental wellbeing (mental component summary, MCS of the SF-36);
3. Subjective disease activity (EULAR Sjögren’s Syndrome Patients Reported Index (ESSPRI));
4. Physical activity (Short Questionnaire to Assess Health-enhancing physical activity (SQUASH));
5. Depressive feelings and anxiety (Hospital Anxiety and Depression Scale (HADS));
6. Self-efficacy concerning fatigue (Self Efficacy Scale-28 (SES-28));
7. Cognitions about physical activity (Tampa Scale for Kinesiophobia (TAMPA-SK));
8. Sleep (SLEEP-50);
9. Physical fitness (Single Stage Submaximal Treadmill Walking Test (SSTWT) and the 6-Minute Walking Test (6MWT));
10. Ocular tear production (Schirmer I test);
11. Salivary production (spitting volume);
12. Disease activity variables: ESR, C reactive protein, IgG, hemoglobin, leukocytes, thrombocyte counts, proinflammatory cytokines, creatinin, ALT, and TSH.
|- Timepoints||1. At baseline: Questionnaires, physical fitness, venipuncture (disease activity), ocular tear production and oral salivary gland production;|
2. Immediately after completing the 10-session intervention: Questionnaires, ocular tear production and oral salivary gland production;
3. Three months after the last session: Physical fitness;
4. Six months after the last session: Questionnaires.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. N. Leeuwen, van|
|- CONTACT for SCIENTIFIC QUERIES||Drs. N. Leeuwen, van|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dutch Arthritis Association (Reumafonds)|
|- Brief summary||Background:|
Invalidating fatigue is a prevalent and debilitating symptom of Sjögren's syndrome and non-Sjögren’s sicca syndrome, i.e., syndromes in which key symptoms are dryness of the eyes (keratoconjunctivitis sicca) and mouth (xerostomia). Although fatigue is indisputably an adverse consequence of the disease, to target fatigue cognitive-behavioural therapy combined with exercise training is most promising. In other diseases and syndromes, this combined therapy has been shown successful, but such interventions have as yet not been evaluated in “dryness” syndromes.
The aim of the study is to examine in patients with primary Sjögren’s syndrome and non-Sjögren’s sicca syndrome whether a cognitive-behavioral therapy and exercise training will reduce fatigue.
A randomised controlled trial with three repeated (pre and post intervention and six months follow-up) assessments in a treatment group (n=48) and a waiting-list control group (n=48). All assessments will also be taken in a non-treatment group with no intention to treat, but otherwise similar to the groups with an intention to treat (n=48).
Patients (≥ 18 years of age) diagnosed with Sjögren’s syndrome (n = 72) and non-Sjögren’s sicca syndrome (n = 72) at the outpatient clinic of the University Medical Centers in Utrecht (UMCU) and Groningen (UMCG) with a score ≥ 14 on the Multidimensional Fatigue Inventory (MFI).
Patients receive a cognitive-behavioral therapy and exercise training in groups of ten participants. Treatment consists of ten sessions within four months and one booster session three months after treatment completion, with every regular session starting with two hours of cognitive behavioral therapy, followed by one hour of exercise training. The patient’s partner (or other significant relation) will attend two sessions.
Main study parameters/endpoints:
Three assessments (pre, post, and 3 or 6-months follow-up) will be taken of the primary outcome variable fatigue as assessed by the Multidimensional Fatigue Inventory (MFI). Secondary outcome variables and mediator variables are: physical functioning (physical component summary of the SF-36), mental wellbeing (mental component summary of the SF-36), subjective disease activity (EULAR Sjögren’s Syndrome Patients Reported Index (ESSPRI)), physical activity (SQUASH), depressive feelings and anxiety (HADS), physical fitness (Single Stage Submaximal Treadmill Walking Test and the 6-Minute Walking Test), ocular tear production (Schirmer I test) and salivary production (spitting volume), self-efficacy concerning fatigue (Self Efficacy Scale-28), cognitions about physical activity (Tampa Scale for Kinesiophobia), sleep (SLEEP-50).
At baseline, basic laboratory and immunologic data will be determined from serum as covariant variables and (surrogate) disease activity variables: ESR, C reactive protein, IgG, hemoglobin, leukocytes, thrombocyte counts, proinflammatory cytokines, creatinin, ALT, and TSH.
|- Main changes (audit trail)|
|- RECORD||5-jul-2012 - 23-jul-2012|
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