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The effect of a graded physical training program on fatigue after stroke.


- candidate number23327
- NTR NumberNTR5485
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2015
- Secondary IDs15-N-138 METC Atrium-Orbis-Zuyd
- Public TitleThe effect of a graded physical training program on fatigue after stroke.
- Scientific TitleThe effect of a graded physcial training program on post stroke fatigue.
- ACRONYM-
- hypothesisThe hypothesis is that a graded physical exercise program in which strength and endurance are trained have a positive effect on fatigue after stroke measured with the CIS-f (Checklist Individual Strength subscale fatigue) or FSS-7 (Fatigue Severity Scale - seven item version)
- Healt Condition(s) or Problem(s) studiedStroke, Fatigue
- Inclusion criteriaThe inclusion criteria are:
- Stroke patients with FFS-7 4 or CIS-F 40
- The stroke occured at least 6 months ago
- The patient is >18 years old
- The patient spreaks Ducht an can follow verbal instructions
- Patient is twice a week available for training in the physiotherapists practice.
- Exclusion criteriaThe exclusion criteria are:
- The patient has a phyciatric disorder (diagnosed according to DSM-IV)
- The patient has a severe communiciation disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-okt-2015
- planned closingdate8-jul-2016
- Target number of participants30
- InterventionsThe participant will receive an 8-week physical training program in which strength and endurance gradually are increased according to the Dutch Guideline for stroke-patients.
The participant will train under supervision of a licensed physiotherapist twice a week.
- Primary outcomePrimary outcome measures are:
- Fatigue as measured by the CIS-f (Checklist Individual Strength subscale fatigue) and FSS-7 (Fatigue Severity Scale-seven item version)
- Secondary outcomeSecondary outcome measures are:
- Strength as measured by handheld- dynamometer and sit-to-stand test.
- Endurance as measured by the six minute walk test (6MWT)
- TimepointsPatients will be assessed at:
T0 --> enrolment (primary and secondary outcome measures)
T1 --> after 4 weeks training (primary outcome measures)
T2 --> after 8 weeks training (primary and secondary outcome measures)
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lian Heijnen
- CONTACT for SCIENTIFIC QUERIES Lian Heijnen
- Sponsor/Initiator Avans Plus Hogeschool
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications-
- Brief summaryThe objective of this study is to evaluate the effect of a graded physical exercise program on fatigue as measured by the CIS-f and FSS-7.
Participants follow an 8-week physical training program in which strength and endurance are gradually increased according to the Dutch guideline for stroke patients.
- Main changes (audit trail)
- RECORD28-okt-2015 - 5-jan-2016


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