No registrations found.
ID
Source
Brief title
Health condition
Post-stroke fatigue
Cognitive Rehabilitation
graded activity
CVA
vermoeidheid
cognitieve revalidatie
Sponsors and support
Prof. dr. L. Fasotti
Donders Insitute for Brain, Cognition and Behaviour.
Radboud University Nijmegen, The Netherlands
Intervention
Outcome measures
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).
Background summary
N/A
Study objective
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.
Study design
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;
Randomisation;
Treatment (COGRAT, or Cognitive treatment alone);
T3: After treatment;
T4: 6 months post treatment follow-up.
Intervention
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;
C. Stretching;
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.
A.M.E.E. Zedlitz
Donders Institue, Centre for Cognition, B02.09
[default] 6500 HE
The Netherlands
+ 31 (0)24 3612646
a.zedlitz@donders.ru.nl
A.M.E.E. Zedlitz
Donders Institue, Centre for Cognition, B02.09
[default] 6500 HE
The Netherlands
+ 31 (0)24 3612646
a.zedlitz@donders.ru.nl
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.
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 |
---|---|
NTR-new | NL2579 |
NTR-old | NTR2704 |
Other | ZonMw / CMO-approved file number : 14350053 / 2007/139 ; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Aglaia M.E.E. Zedlitz, MSc; Toni C.M. Rietveld, PhD; Alexander C. Geurts, MD, PhD; Luciano Fasotti, PhD<br>
Stroke. 2012; 43: 1046-1051 Published online before print February 2, 2012, doi: 10.1161/​STROKEAHA.111.632117