|- candidate number||8975|
|- NTR Number||NTR2704|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jan-2011|
|- Secondary IDs||14350053 / 2007/139 ; ZonMw / CMO-approved file number |
|- Public Title||Treatment of severe fatigue after stroke. A study of cognitive therapy and physical exercise training in eight rehabilitation centres in the Netherlands.|
|- Scientific Title||Effectiveness of Cognitive and Graded Activity Training (COGRAT) on post-stroke fatigue. A multi-center study.|
|- hypothesis||Stroke patients frequently complain of excessive fatigue, both in post-acute and in the chronic stage of their illness. The prevalence of severe fatigue is estimated between 28-73%, even in patients who seem to recover well. This may lead to impairments in daily functioning. Although clinicians are aware that a treatmnet for PSF is urgently needed, there are no evidence-based treatments available. On the basis of positive outcomes of a pilot-study of a cognitive and physical treatment in the Maartenskliniek, the protocol was adapted and a multi-center randomised waiting-list controlled study proposed. This cognitive and graded activity training (COGRAT) is offered to stroke patients in the chronic phase (> 4 mnts post stroke), and compared to the Cognitive therapy alone, and waiting list condition.|
The hypotheses are: Cognitive and Graded Activity Training (COGRAT) will be helpfull in decreasing chronic fatigue after stroke. Furthermore the addition of a Graded activity programme will enhance the effectiveness of the treatment.
|- Healt Condition(s) or Problem(s) studied||Stroke, Fatigue, Cognitive rehabilitation|
|- Inclusion criteria||1. Post-onset of stroke at least 4 months;|
2. Age between 18 and 70 years;
3. Checklist Individual Strength (CIS) fatigue severity score of 40 or more;
4. Rivermead Mobility Index > 11/15 (able to walk independently).
|- Exclusion criteria||1. Severe cognitive impairments (severe neglect, severe memory problems, severe planning problems, denial of illness);|
2. Psychopathology (clinical interview and HADS-depression score >10);
3. Severe cardiac and pulmonary disease.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-mei-2007|
|- planned closingdate||1-okt-2011|
|- Target number of participants||96|
|- Interventions||COGRAT consist of 2 arms given alongside during 12 weeks.
1. Cognitive strategy training: Frequency; 1x week for 2 hours (& homework) in small groups (max 4 patients). It consists of:
A. Patient education on fatigue after stroke and sleep hygiene;
B. Gaining insight into the individual activity and fatigability pattern by logging activities and fatigue;
C. Cognitive strategy training in order to prevent fatigue and manage existing fatigue. These strategies are: modification of activity patterns, improvement of planning abilities and the use of relaxation and leisure activities;
D. Cognitive behavioural Therapy (CBT) to enhance behavioural change and to assist in managing existing fatigue.
2. Graded Activity Training: Frequency: 2x week, for 2 hours & homework assignments.
A. Walking on a treadmill (with increasing inclination);
B. Strength training;
Maximum heart rate and strength are increased from 40% at the beginning of the training and increased during the treatment to a maximum of 70% at the end of the 12 weeks.
|- Primary outcome||Fatigue severity (Checklist Individual Strength, fatigue severity score).|
|- Secondary outcome||1. Psychosocial well-being (SCL-90 & HADS);|
2. Functional impairments (SA-SIP-30);
3. Physical condition (6 minute walking test);
4. Activity (actometers & registration);
5. Attention (SART & ANT);
6. Memory (RMBT & CVWLT);
7. Cognitive complaints (CIS-C, CFQ);
8. Coping (CISS);
9. Attribution (SES & FCS);
10. Social support (SSL).
|- Timepoints||All questionaires and tests are performed at all testing points (T1-T4).
T1: 3 months prior to randomisation and treatment;|
T2: Prior to randomisation and treatment;
Treatment (COGRAT, or Cognitive treatment alone);
T3: After treatment;
T4: 6 months post treatment follow-up.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc. A.M.E.E. Zedlitz|
|- CONTACT for SCIENTIFIC QUERIES||MSc. A.M.E.E. Zedlitz|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Cognitive and Graded Activity Training Can Alleviate Persistent Fatigue After Stroke: A Randomized, Controlled Trial.|
Aglaia M.E.E. Zedlitz, MSc; Toni C.M. Rietveld, PhD; Alexander C. Geurts, MD, PhD; Luciano Fasotti, PhD
Stroke. 2012; 43: 1046-1051 Published online before print February 2, 2012, doi: 10.1161/STROKEAHA.111.632117
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||20-jan-2011 - 22-sep-2012|