Clinical trial NCT04115215: Pre-FRONTal Brain STability, Key for Action Against Disability in AGing
Official title: Pre-FRONTal Brain STability, Key for Action Against Disability in AGing: The FRONT STAGE Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Motoric Cognitive Risk Syndrome
Keywords: Older adults
Cognitive impairment
Motoric Cognitive Risk Syndrome
Physical disfunction
Multi-component physical exercise program
Transcranial electrical stimulation
Lead sponsor: Parc Sanitari Pere Virgili
Sponsor class: OTHER
Collaborators: name: Institute for Photonic Sciences - ICFO
name: Hospital de la Ribera
name: Fundacio Ictus Malaltia Vascular
name: Institut Català de la Salut
name: Vall d'Hebron Research Institute (sponsor)
First posted: 2019-10-03
Enrollment: 93
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cognitive and mobility impairments are critical contributors to dementia and disability in older adults, and can be caused by neurodegenerative and neurovascular changes at the pre-frontal (PF) brain areas. In a previous technological project funded by ISCiii, the investigators adapted a non-invasive, point-of-care optical methods (fNRIS/fDCS technology) to study PF metabolism and blood flow activation during cognitive and motor tasks, in older adults with and without cognitive impairment. These methods are sensitive to change after physical exercise (PE) and after selectively and safely stimulating PF areas with electrical transcranial direct current stimulation (tCS). PE and tCS have shown benefits for cognition and mobility in the elderly, but their prolonged effect on PF hemodynamic activation has not been studied. Understanding the specific action of these interventions on the brain, and their clinical cognitive and motor impact, is key to fine-tune appropriate treatment strategies.

The FRONT STAGE project aims to compare, through a 3 arms single-blind randomized clinical trial, the impact of a 10 weeks, 1 hour/week program of PE (arm 1) Vs PE+tCS (arm 2) and Vs a control group (arm 3, healthy aging sessions and control of cardiovascular risk factors). The PE program is already implemented in primary care, as part of another previous project of the investigators' research group. Outcomes will include the optical measurement of PF metabolism and blood flow and clinical measures of cognitive and physical function. Front STAGE project will recruit 93 older adults with cognitive impairment and slow gait, but without dementia or disability in the activities of daily living (N=31 per arm). They will receive a comprehensive geriatric assessment at baseline, together with the optical, cognitive and physical measures, and will be follow-up at 3 and 6 months. Weekly physical activity through accelerometry will be controlled in analyses.

FRONT STAGE project centered on aging and the prevention of dementia and disability, will provide, translationally, more evidence to support and enlarge the clinical application of these interventions, and will contribute to foster further research in this field.


Eligibility criteria: Inclusion Criteria:

1. older adults (65 years or older)
2. with Motoric Cognitive Risk Syndrome
3. characterized by impaired cognition (which in our case will be confirmed with a Spanish version of the Montreal cognitive Assessment (MOCA), score between 26 and 21)
4. mobility impairment (measured as slow gait speed\<0.8 m/s)
5. without diagnosed clinical neurological or psychiatric diseases
6. with a preserved functional status for the activities of daily living
7. who can walk without help from third parties

Exclusion Criteria:

1. a diagnosis of dementia
2. advanced/terminal disease (life expectancy\<1 year)
3. contraindications to exercise and tCS
4. unwilling to give informed consent

Primary outcomes:
measure: Changes in hemoglobin oxygenation during functional tasks, as measured using fNIRS+fDCS optical techniques.
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
Secondary outcomes:
measure: Cognitive executive function tests - Phonetic Verbal Fluency
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Cognitive executive function tests - SDMT
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Physical function
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Motor function
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Cognitive executive function tests - Digit span
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Cognitive executive function tests - Trail Making Test
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
Other outcomes:
measure: Spatial temporal parameters of gait
timeFrame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.
measure: Total time of daily physical activity
timeFrame: 7 consecutive days (arms 2 & 3) just after the start of the intervention.
measure: Clinical comorbidity
timeFrame: Baseline.
measure: Nutritional status
timeFrame: Baseline.
measure: Demographics
timeFrame: Baseline.
measure: Self-reported quality of life
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: Baseline
measure: Quality of sleep
timeFrame: Baseline
measure: Drugs
timeFrame: Baseline
measure: Hypertension
timeFrame: Baseline
measure: Cholesterol
timeFrame: Baseline
Locations:
city: Castelldefels
country: Spain
facility: The Institute of Photonic Sciences (ICFO)
state: Barcelona
city: Alzira
country: Spain
facility: Hospital Universitario La Ribera
state: Valencia
city: Barcelona
country: Spain
facility: Institut Català de la Salut
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
city: Barcelona
country: Spain
facility: Fundació Ictus
Study officials:
affiliation: Parc Sanitari Pere Virgili - Vall d'Hebron Institute of Research
name: Marco Inzitari, PhD
role: PRINCIPAL_INVESTIGATOR
References: