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

NCT04507386 | Unknown

• 1 other identifier: Take a STAND for Health MCI
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Sedentary behaviour assessed by ActivPAL™

  4 months

Secondary Outcomes (25)

• Physical activity levels assessed by ActiGraph GT3X®

  4 months

• Cognitive performance assessed by the Montreal Cognitive Assessment (MoCA)

  4 months

• Cognitive decline assessed by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

  4 months

• Subjective memory complaints assessed by the Memory Complaint Scale (MCS)

  4 months

• Functional impairments in activities of daily living assessed by the Functional Activities Questionnaire (FAQ)

  4 months

Study Arms (2)

Take a STAND for health

EXPERIMENTAL

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

Behavioral: Take a STAND for health

Control

NO INTERVENTION

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

Interventions

Take a STAND for health BEHAVIORAL

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

Take a STAND for health

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Health

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share