|- candidate number||23662|
|- NTR Number||NTR5668|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jan-2016|
|- Secondary IDs||NL51973.029.15 |
|- Public Title||Het effect van beweging op de bloeddoorstroming in de hersenen bij patiënten met vasculaire cognitieve stoornissen|
|- Scientific Title||The effect of aerobic exercise on cerebral perfusion in patients with vascular cognitive impairment|
|- hypothesis||We aim to assess whether aerobic exercise leads to increased cerebral perfusion in patients with vascular cognitive impairment. |
|- Healt Condition(s) or Problem(s) studied||Vascular dementia, Cognitive decline, Physical activity|
|- Inclusion criteria||• Age: ≥50 years.|
• Cognitive complaints
• Independency in daily life.
• Clinical Dementia Rating (CDR) score ≤ 0,5 and Mini Mental State Examination (MMSE) ≥ 22.
• Presence of a primary caregiver.
Furthermore, at least one of the following criteria should be present:
• On brain MR, moderate to severe white matter lesions (Fazekas > 1) and/or (lacunar) infarct(s) and/or intracerebral (micro-)haemorrhage(s).
• On brain MR, mild white matter lesions (Fazekas = 1) and at least two of the following vascular risk factors: hypertension, hypercholesterolemia, diabetes mellitus, obesity, smoking or clinically manifest vascular disease (last event > 6 months ago). Clinically manifest vascular disease comprises peripheral arterial disease, myocardial infarction, percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG), and/or stroke.
|- Exclusion criteria||• Diagnosis of dementia.
• Contra-indication for MRI or unable to undergo MRI protocol due to a physical condition.
• Participation in aerobic exercise program (moderate-to-hard intensity) ≥ twice weekly on a regular basis.
• Major neurological (e.g. Parkinson’s disease, multiple sclerosis), cardiac (e.g. heart-failure, severe aorta stenosis, cardiac rhythm disturbances) or other medical disease that affects cognition and mobility and constitutes a contra-indication to perform aerobic exercise training.
• Clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility.
• Other neurological diagnosis, such as severe traumatic brain injury, or major psychiatric disorder, such as psychosis, schizophrenia, severe personality disorder or depression with vital signs, alcohol abuse or other substances, that could affect cognitive performance during neuropsychological assessment.
• Participation in on-going trials for therapeutic interventions including randomized controlled trials and clinical trials investigating medicinal products.|
• Insufficient proficiency of the Dutch language.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-okt-2015|
|- planned closingdate||5-okt-2018|
|- Target number of participants||80|
|- Interventions||Participants are randomly assigned to either the aerobic exercise program or to the usual care control group. The aerobic exercise program aims to improve the cardiorespiratory fitness of the participants. Participants are provided with a bicycle ergometer at home, on which they are asked to perform the exercise sessions. |
The total exercise program takes 14 weeks. Sessions take place three times a week for approximately 45 minutes. Each session consists of a warming-up (10 minutes), a core activity (25 min) and a cooling-down (10 min).
|- Primary outcome||• Change in cerebral blood flow (CBF), measured with Arterial Spin-Labeling-Magnetic Resonance Imaging (ASL-MRI). |
|- Secondary outcome||• Change in cognitive functions on neuropsychological testing;
• Change in brain structure;
• Change in physical fitness;
• Change in blood biomarkers;
• Change in (i)ADL, neuropsychiatric measures and quality of life; |
• Change in cerebral autoregulation;
• Change in cerebral vasomotor reactivity;
Follow-up (after intervention period)
|- Trial web site||http://www.alzheimercentrum.nl/onderzoek/nieuwe-onderzoeksprojecten/|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Annebet E. Leeuwis|
|- CONTACT for SCIENTIFIC QUERIES|| Annebet E. Leeuwis|
|- Sponsor/Initiator ||VU University Medical Center, University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||The ExCersion-VCI is a multi-center, single-blind randomized controlled trial among 80 non-demented patients with VCI. Patients with VCI are recruited from two medical centers (VU University medical center and University Medical Center Utrecht). Participants are randomized into an aerobic exercise program (n = 40) or into a control condition (n = 40). The aerobic exercise program aims to improve cardiorespiratory fitness. The primary outcome measure is change in CBF, measured with Arterial Spin-Labeling-Magnetic Resonance Imaging (ASL-MRI). Secondary outcome measures include change in cognitive and physical functioning, change in brain function and structure, change in blood biomarkers and change in iADL and quality of life.|
|- Main changes (audit trail)|
|- RECORD||27-jan-2016 - 20-mrt-2016|