Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2024-08-31

Brief Summary

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This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in patients with mild cognitive impairment. A 4-month parallel-group randomized controlled trial will be conducted aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in patients with mild cognitive impairment. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.

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Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 4-month parallel-group randomised controlled trial will be performed, in which patients with mild cognitive impairment will be assessed at baseline (PRE) and after 4 months (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Take a STAND for health

A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity

Group Type EXPERIMENTAL

Take a STAND for health

Intervention Type BEHAVIORAL

The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior

Control

The control group will receive regular medical care and advice on healthy lifestyle, including physical activity and healthy eating recommendations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Take a STAND for health

The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP

Exclusion Criteria

* Patients who spend less than 8 hours per day in sedentary time
* Patients who are physically active (more than 150 min/week of moderate physical activity, or more than 75 min/week of vigorous activity)
* Patients who are functional illiterates
* Patients with history or clinical diagnosis of neurological diseases
* Patients with severe psychiatric symptoms
* Patients taking antidepressants
* Patients with visual and/or hearing impairments that prevent participation

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No