Pre-FRONTal Brain STability, Key for Action Against Disability in AGing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2023-03-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognitive Impairment Motoric Cognitive Risk Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The investigators performing the follow-up assessments will be blind to randomization. In light of the difficulty to guarantee a complete blinding, these investigators will record if blinding is disclosed by participants during the interview.

Study Groups

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Arm 1

Physical exercise (PE)

Group Type EXPERIMENTAL

Physical exercise (PE)

Intervention Type BEHAVIORAL

This arm includes 10 sessions of multi-component exercise sessions (including aerobic, resistance, flexibility, dual-tasking) of 1 hour/week of functional group exercise, directed to foster empowerment for subsequent continuation of exercise in community-dwelling older adults referred by primary care to a geriatrician and an expert physical therapist. Participants will receive a leaflet with instructions to perform five strength-based exercises and instructors will recommend participants to perform the exercises and walk at least 15 minutes daily.

Arm 2

Transcranial current stimulation (tCS)

Group Type EXPERIMENTAL

Physical exercise (PE)

Intervention Type BEHAVIORAL

This arm includes 10 sessions of multi-component exercise sessions (including aerobic, resistance, flexibility, dual-tasking) of 1 hour/week of functional group exercise, directed to foster empowerment for subsequent continuation of exercise in community-dwelling older adults referred by primary care to a geriatrician and an expert physical therapist. Participants will receive a leaflet with instructions to perform five strength-based exercises and instructors will recommend participants to perform the exercises and walk at least 15 minutes daily.

Transcranial current stimulation (tCS)

Intervention Type DEVICE

This arm includes 1 application/week for 10 weeks during PE, through an adapted commercial helmet. Transcranial current stimulation (tCS) is a neural stimulation technique based on electrical stimulation of selected parts of the brain with direct or alternated electrical current (tDCS or tACS) of very low intensity of 1,5 milliamps (mA), using one or more electrodes placed on the skull. tCS is non-invasive (no surgical procedures) and it is painless, as applied in the proposed protocols.

Control

Educational sessions on healthy aging

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Participants of similar profile, randomized to the control group, will undergo weekly 30 minutes educational sessions on healthy aging, including relevant aspects of nutrition, self-care, physical activity, plus measurement of blood pressure, heart rate and peripheral oxygen Hb saturation. These participants will be offered to join the PE program after the 6-months follow-up (end of the study).

Interventions

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Physical exercise (PE)

This arm includes 10 sessions of multi-component exercise sessions (including aerobic, resistance, flexibility, dual-tasking) of 1 hour/week of functional group exercise, directed to foster empowerment for subsequent continuation of exercise in community-dwelling older adults referred by primary care to a geriatrician and an expert physical therapist. Participants will receive a leaflet with instructions to perform five strength-based exercises and instructors will recommend participants to perform the exercises and walk at least 15 minutes daily.

Intervention Type BEHAVIORAL

Transcranial current stimulation (tCS)

This arm includes 1 application/week for 10 weeks during PE, through an adapted commercial helmet. Transcranial current stimulation (tCS) is a neural stimulation technique based on electrical stimulation of selected parts of the brain with direct or alternated electrical current (tDCS or tACS) of very low intensity of 1,5 milliamps (mA), using one or more electrodes placed on the skull. tCS is non-invasive (no surgical procedures) and it is painless, as applied in the proposed protocols.

Intervention Type DEVICE

Control

Participants of similar profile, randomized to the control group, will undergo weekly 30 minutes educational sessions on healthy aging, including relevant aspects of nutrition, self-care, physical activity, plus measurement of blood pressure, heart rate and peripheral oxygen Hb saturation. These participants will be offered to join the PE program after the 6-months follow-up (end of the study).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No