NCT03578614

Impact of Physical Activity in Vascular Cognitive Impairment ( AFIVASC )

Randomized Interventional Prospective Study of the Effect of Physical Activity in Vascular Cognitive Impairment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Instituto de Medicina Molecular João Lobo Antunes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vascular cognitive impairment (VCI) is one of the most frequent causes of cognitive impairment associated with aging. So far, there is no approved treatment for VCI. Recent studies have suggested a protective effect from physical activity but adequate studies are lacking in this field. The AFIVASC study - a Portuguese acronym for "physical activity in vascular cognitive impairment" is a randomized controlled study, single-blinded, nonpharmacological which aims to explore the benefits of physical activity in vascular cognitive impairment (VCI)

Detailed description

Vascular cognitive impairment is one of the most frequent causes of cognitive impairment associated with aging. Vascular cognitive impairment includes clinical deficits due to vascular subclinical brain injury, silent lesions or due to clinically overt stroke, and appears frequently associated with Alzheimer disease. Vascular cognitive impairment has a spectrum of manifestations, from mild to extreme manifestation (Vascular Dementia) that represents the second most frequent cause of dementia. There is no approved treatment for vascular cognitive impairment, and pharmacological trials have generated disappointing results. As a result, nowadays, treatment is solely based on the control of vascular risk factors. Walking is a physical activity recommended for the prevention of coronary disease. Besides, it is a physical activity without additional costs, easily accessible to the general population, and can be used in the whole population. Physical activity can potentially prevent functional decline associated with aging and promote global health status. In recent years, a growing interest has been given to the impact of physical activity as a protective factor for cognitive decline and for the progression for dementia There are several explanations for the protective effect in cognition: physical activity can implicate a better physical and global mental status, but can also be mediated through metabolic, physiopathological effects, as the increase cerebral inflow, the reduction of vascular risk factors, the decrease of production of stress hormones or still better endothelial function, among others. However, there is no consensus in this field. Some studies showed a protective effect of physical activity in Alzheimer disease. Protective effect of physical activity on vascular cognitive impairment (including dementia) has still to be proved. There are small studies with short follow-up, that do not take in consideration relevant confounding factors or imaging data (e.g. evidence of small vessel disease) with controversial results. Recently a large observational study showed the beneficial impact of physical activity (defined according to the American Heart Association as at least 30 minutes of physical activity at least 3 times a week) in the reduction of the risk of progression for vascular dementia, in a cohort of subjects older than 65 years old, living independently, with cerebral white matter changes, and controlling for confounding factors. Additionally, in subjects with evidence of small vessel disease and no cognitive decline, physical activity was associated with better executive performance overtime. The existing studies do not come from adequate randomized and double-blind designs, so there is no evidence-based data to sustain a recommendation for the type, intensity or frequency of physical activity, and the long-term gain. Given these contradictory findings, it becomes relevant to have an evidence-base to recommend physical activity in vascular cognitive impairment and in what concerns the type, intensity, and frequency of activity which would be necessary to achieve longterm gains.

Conditions

• Vascular Cognitive Impairment

Interventions

Type	Name	Description
OTHER	Physical Activity	3 physical activity sessions are planned by week, 2 supervised and 1 non-supervised conducted over 6 months. On the first 2 months, the supervised sessions have 10 minutes of warm-up + 5 minutes active pause (balance, agility and coordinative exercises) + 15 minutes walking + 5 minutes active pause (resistance exercises - 1 series of 12 repetitions \- 3 callisthenic exercises) + 15 minutes walking + 5 minutes flexibility (1 series of 10 seconds in 3 different postures). The aimed intensity in these first two months is 12/13. Between the 2nd and the 4th months, the duration of the walking period increases, as well as the intensity, RPE 13/14. Between the 4th and the 6th months, again the duration of the walking period increases, as well as the intensity, RPE 14/15. To measure the intensity level of the physical activity, the Borg Rating of Perceived Exertion (RPE) ranging from 6 (rest) to 20 (maximum effort) is used.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-12-31
• Completion: 2020-06-30
• First posted: 2018-07-06
• Last updated: 2021-04-01

Locations

1 site across 1 country: Portugal