Impact of Physical Activity in Vascular Cognitive Impairment ( AFIVASC )

NCT03578614 | Completed DMC

• 1 other identifier: FCT-PTDC/DTP-ES/3706/2014
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Vascular Cognitive Impairment

Keywords

Vascular cognitive impairment; Physical Activity; Randomized Clinical Trial; Stroke; TIA; Small Vessel Disease

Outcome Measures

Primary Outcomes (2)

• Clinical Cognitive Criteria

  Defined by a transition to dementia (all types) in patients with vascular cognitive impairment no dementia or transition to vascular cognitive impairment no dementia in those subjects with previous stroke/TIA without criteria for vascular cognitive impairment no dementia. This cognitive criteria will be assessed by a clinical neurologist

  1 year

• Cognitive Status measured by neuropsychological measures

  Change in neuropsychological evaluation (1.5 SD of initial medium score) for composite scores calculated by averaging all different domains of the tests applied or for global measures (MOCA).

  1 year

Secondary Outcomes (3)

• Impact of physical activity in interpersonal, environmental, functional, physical, and psychological domains (Quality of Life) measured by Portuguese version of Quality of Live scale in Alzheimer's disease (QOL-AD)

  1 year

• Impact of physical activity in motor status

  1 year

• Impact of physical activity in functional status

  1 year

Study Arms (2)

Control Group

NO INTERVENTION

There is no intervention for Control Group

Intervention Group

EXPERIMENTAL

Intervention Group will be submitted to three physical activity sessions (two supervised and one nonsupervised) conducted over 6 months

Other: Physical Activity

Interventions

Physical Activity OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are included if they are older than 18 years
• Fluent in Portuguese language;
• Able to read and write;
• Availability of a reliable informant;
• Fulfill the written informed consent;
• Clinical and functional criteria A and B:
• Criteria A: 1 of the following 3:
• Probable mild cognitive vascular impairment;
• Previous ischemic or hemorrhagic stroke (at least 6 months before), with modified Rankin ≤ 2 at baseline and without formal indication for physiotherapy.
• TIA (at least more than a 1 month before), diagnosed by a neurologist or with identified vascular lesion (correlated with TIA clinical symptoms) in CT/MRI.
• Criteria B: No functional changes: IADL 0 (no item changed, or 1 single item with minimal change), according to the scoring methods of the LADIS study (minimum of 4 items applicable) or no cognitive changes regarding the suggested Montreal Cognitive Assessment Test (Moca) cut off point for dementia in clinical Portuguese samples (score \< 17).

You may not qualify if:

• Diagnosis of dementia;
• Stroke with formal indication for physiotherapy or speech therapy, or Rankin ≥ 2;
• Any contraindication for walking, physical limitation to gait (orthopedic or other structural) that compromises the therapy proposed, or physical or mental limitation that could potentially interfere with the active treatment proposed (e.g. severe arthritis, severe osteoarticular pain associated with walking);
• Evidence of neurodegenerative disease (other than vascular aetiology), significant psychiatric disease (e.g. major depressive episode) or medical disease with prognosis or severity which could significantly interfere with the subjects' participation, or with quality of life (e.g. cancer, severe cardiovascular disease as congestive heart failure, uncontrolled angina).

Sponsors & Collaborators

• Instituto de Medicina Molecular João Lobo Antunes: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Instituto de Medicina Molecular João Lobo Antunes

Lisbon, 1649-028, Portugal

Location

Related Publications (2)

• Verdelho A, Correia M, Ferro JM, Madureira S, Vilela P, Rodrigues M, Borges M, Oliveira V, Santos AC, Goncalves-Pereira M, Santa-Clara H. Physical Activity Self-Report Is Not Reliable Among Subjects with Mild Vascular Cognitive Impairment: The AFIVASC Study. J Alzheimers Dis. 2022;87(1):405-414. doi: 10.3233/JAD-215381.

  PMID: 35275531 DERIVED

• Verdelho A, Madureira S, Correia M, Ferro JM, Rodrigues M, Goncalves-Pereira M, Goncalves M, Santos AC, Vilela P, Barrios H, Borges M, Santa-Clara H. Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial. Trials. 2019 Feb 11;20(1):114. doi: 10.1186/s13063-019-3174-1.

  PMID: 30744681 DERIVED

MeSH Terms

Conditions

Motor Activity; Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador, Clinical Professor, Neurologist

Model Details: Single-blind, randomized controlled trial, with a six-month intervention treatment and an additional follow-up of six months. After a four-week run-in period, the participants are randomized into two parallel groups (control group and intervention group).

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 6, 2018
• Study Start: September 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

PT (1)