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van CCT (UK)

van CCT (UK)

Treatment of severe fatigue after stroke. A study of cognitive therapy and physical exercise training in eight rehabilitation centres in the Netherlands.

- candidate number8975
- NTR NumberNTR2704
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jan-2011
- Secondary IDs14350053 / 2007/139 ; ZonMw / CMO-approved file number
- Public TitleTreatment of severe fatigue after stroke. A study of cognitive therapy and physical exercise training in eight rehabilitation centres in the Netherlands.
- Scientific TitleEffectiveness of Cognitive and Graded Activity Training (COGRAT) on post-stroke fatigue. A multi-center study.
- hypothesisStroke 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) studiedStroke, Fatigue, Cognitive rehabilitation
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-mei-2007
- planned closingdate1-okt-2011
- Target number of participants96
- InterventionsCOGRAT 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.
- Primary outcomeFatigue severity (Checklist Individual Strength, fatigue severity score).
- Secondary outcome1. 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).
- TimepointsAll 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 siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsCognitive 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 summaryN/A
- Main changes (audit trail)
- RECORD20-jan-2011 - 22-sep-2012

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