Abstract
Background
Cognitive impairment and cerebrovascular pathology are both frequent with ageing. Cognitive impairment due to vascular pathology of the brain, termed vascular cognitive impairment (VCI), is one of the most frequent causes of cognitive impairment in elderly subjects. Thus far, VCI has no specific pharmacological treatment. Recent observational studies have suggested a protective effect of physical activity in cognition, but adequate randomised controlled trials (RCT) are lacking.
Methods
AFIVASC is a multi-centre randomised controlled trial, with a 6-month intervention treatment and an additional follow-up of 6 months, that aims to estimate the impact of 6 months of moderate intensity physical activity on cognition (the primary outcome) at 6 and 12 months in subjects with VCI. Participants are community dwellers with criteria for VCI without dementia or who have had previous stroke or transient ischaemic attack (TIA). Patients may be self-referred or referred from a medical appointment. After confirming the inclusion criteria, a run-in period of 1 month is conducted to access adherence; only after that are subjects randomly assigned (using a computerised program blinded to clinical details) to two groups (intervention group and best practice usual care group). The intervention consists of three physical activity sessions of 60 min each (two supervised and one unsupervised) per week. The primary outcome is measured by the presence or absence of decline in cognitive status. Secondary outcomes include changes in neuro-cognitive measures, quality of life, and functional and motor status. Primary and secondary outcomes are evaluated at 6 and 12 months by investigators blinded to both intervention and randomisation. A required sample size of 280 subjects was estimated. Statistical analyses will include regression analysis with repeated measures. The study was approved by the Ethics Committee for Health of Centro Hospitalar de Lisboa Norte (ref. no. 1063/13) and by the Ethics Committee for Health of Centro Hospitalar do Porto CHP (ref. no. 2016.055(049-DEFI/048-CES)).
Discussion
We aim to show whether or not moderate physical activity has a beneficial impact on cognition, quality of life, motor, and functional status in people with vascular cognitive impairment, and to generate new insights on the applicability of implementing physical activity in this specific population.
Trial Registration
ClinicalTrials.gov, NCT03578614 July 6, 2018.
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Details
1 Centro Hospitalar Universitário Lisboa Norte Hospital de Santa Maria, Instituto de Medicina Molecular (IMM) and Instituto de Saúde Ambiental (ISAMB), Universidade de Lisboa, Department of Neurosciences and Mental Health, Faculdade de Medicina, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)
2 Universidade Nova de Lisboa, Instituto de Medicina Molecular (IMM), Faculdade de Medicina, Universidade de Lisboa, Department of Psychology, ISCTE-IUL, NOVA Medical School / Faculdade de Ciências Médicas, Lisbon, Portugal (GRID:grid.9983.b)
3 Hospital de Santo António, Centro Hospitalar do Porto and Instituto de Ciências Biomédicas Abel Salazar (ICBAS), University of Porto, Neurology Service, Porto, Portugal (GRID:grid.5808.5) (ISNI:0000 0001 1503 7226)
4 Hospital de Santa Maria-CHLN, Faculdade de Medicina, Universidade de Lisboa, Instituto de Medicina Molecular (IMM), Faculdade de Medicina, Universidade de Lisboa and Department of Neuroscience, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)
5 Instituto de Medicina Molecular (IMM), Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)
6 Universidade Nova de Lisboa, CEDOC, Chronic Diseases Research Center, NOVA Medical School /Faculdade de Ciências Médicas, Lisbon, Portugal (GRID:grid.10772.33) (ISNI:0000000121511713)
7 Universidade de Lisboa, Instituto de Medicina Molecular (IMM), Faculdade de Medicina, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)
8 Universidade de Lisboa and Dementia Unit, Hospital do Mar, Instituto de Medicina Molecular (IMM), Faculdade de Medicina, Lisbon, Portugal (GRID:grid.435034.5)
9 Hospital da Luz, Neuroradiology - Imaging Department, Lisbon, Portugal (GRID:grid.414429.e) (ISNI:0000 0001 0163 5700)
10 Universidade Nova de Lisboa, Portugal and Instituto de Medicina Molecular (IMM), Hospital do Mar Lisboa, Faculdade de Medicina, Universidade de Lisboa, NOVA Medical School, Lisbon, Portugal (GRID:grid.10772.33) (ISNI:0000000121511713)
11 Universidade de Lisboa and Faculdade de Motricidade Humana,Universidade de Lisboa, Instituto de Medicina Molecular (IMM), Faculdade de Medicina, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)
12 Universidade de Lisboa, CIPER – Centro Interdisciplinar de Estudo da Performance Humana, Faculdade de Motricidade Humana, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263)