Double-task Exercise in Older Adults at Risk of Cognitive Decline (MeMo-Health-Cog-3 Program)

NCT04068376 | Active Not Recruiting

• 2 other identifiers: 2018-785-0952023-3-146
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral small vessel disease is a frequent cause of cognitive disability among older adults (OAs) in Mexico that imposes a significant burden on the health system and OAs' families. We have called the program Mind and Movement for Cognitive Health (MeMo-Salud-Cog-3). Programs to prevent or delay OAs' cognitive decline are scarce. Methods and analysis: A double-blind, randomized clinical trial will be conducted. The study will aim to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for OAs at risk of cognitive decline-one program with and another without caregiver participation-and to compare these with an aerobic-balance-stretching exercise program (control group). 255 OAs (85 per group) affiliated with the Mexican Institute of Social Security (IMSS) between 60 and 65 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups. The intervention will last 24 weeks, and the effect of each program will be evaluated 12, 24, and 52 weeks after the intervention. Participants' demographic and clinical characteristics will be collected at baseline. The outcomes will include: (i) general cognitive function; (ii) specific cognitive functions; (iii) dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) OAs' health-related quality of life; and (viii) caregiver burden. We will estimate differences in outcomes between each intervention group and the control group at baseline and follow-up evaluations. We will assess differences-in-differences (D-in-D) treatment effects using a D-in-D estimator. If we identify statistically significant differences in participants' baseline characteristics between the groups, we will adjust the D-in-D estimators by these covariates using generalized linear regression models. Ethics and dissemination: The study was approved by the IMSS Ethics and Research Committee (registration number 2018-785-095). All participants will sign a consent form prior to their participation. The study results will be disseminated to IMSS authorities, healthcare providers and the research community.

Conditions

Cognitive Decline; Vascular Health

Keywords

cognitive decline; double task; older adults

Outcome Measures

Primary Outcomes (9)

• General Cognitive funtion

  i) Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehens cognitive assessment, with total scores ranging from 0 to 69.

  0 weeks

• General Cognitive funtion

  i) Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehensive cognitive assessment, with total scores ranging from 0 to 69.

  24 weeks

• General Cognitive funtion

  i) Subjective memory complaints were evaluated through five questions: "Do you have difficulty remembering things?" "Do you feel as though you have forgotten conversations?" "Have you asked the same question several times?" "Have you recently forgotten to turn off the stove?" "Do you think you have memory problems?" Each affirmative response was scored one point, while a negative response received zero points. Therefore, the minimum possible score was zero, and the maximum was five points. ii) The Mini-Mental State Examination (MMSE) uses a 0 to 30-point scale to identify mild cognitive impairment. iii) The Montreal Cognitive Assessment (MoCA), also on a 0 to 30-point scale. iv) The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) assesses cognitive function through 11 items related to memory, language, praxis, and orientation, providing a comprehens cognitive assessment, with total scores ranging from 0 to 69.

  52 weeks

• Specific domains of cognitive function

  Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter. The frontal assessment battery (FAB)

  0 weeks

• Specific domains of cognitive function

  Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.

  24 weeks

• Specific domains of cognitive function

  Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal learning and memory will be assessed through Rey's Auditory Verbal Learning Test (RAVLT) that consists of documenting the number of words remembered from a list of 15 words presented in two separate moments; this test allows evaluation of the RAVLT-Immediate and RAVLT-Percent Forgetting. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.

  52 weeks

• Cognitive reserve

  Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.

  0 weeks

• Cognitive reserve

  Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.

  24 weeks

• Cognitive reserve

  Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.

  52 weeks

Secondary Outcomes (18)

• Usual walking and dual-task gait

  0 weeks

• Usual walking and dual-task gait

  24 weeks

• Usual walking and dual-task gait

  52 weeks

• Carotid intima-media thickness (cIMT)

  0 weeks

• Carotid intima-media thickness (cIMT)

  24 weeks

Study Arms (3)

Control group (C-GR)

ACTIVE COMPARATOR

Control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).

Other: "Mind and Movement for Cognitive Health in the Older Adult"; Other: Double-task exercise by older adults and their caregivers

T1-GR training sessions by health professional

EXPERIMENTAL

The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health professional with a nursing background previously certified to coach SSE trainings by the Institute of Square-Stepping Exercise in Mie, Japan (Chief Tomohiro Okura and Overseas Director Professor Ryosuke Shigematsu).

Other: Control excercise

T2-GR older adults and their caregivers

EXPERIMENTAL

In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.

Other: Control excercise

Interventions

Control excercise OTHER

Each session will be for 60 minutes, 3 days a week, for 24 weeks. The make-up of each session is 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of balance-stretching exercise; and 5) 5 minutes of cool-down stretching (this times does not count as activity).

Also known as: Aerobic-balance-stretching exercise program

T1-GR training sessions by health professional; T2-GR older adults and their caregivers

"Mind and Movement for Cognitive Health in the Older Adult" OTHER

The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health profesional certified to coach SSE. The make-up of each session is: 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of double-task exercise (mat); and 5) 5 minutes of cool-down stretching (this times does not count as activity).

Also known as: Double-task exercise by a health professional

Control group (C-GR)

Double-task exercise by older adults and their caregivers OTHER

In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called "pacers," and they supervise physical activity through active accompaniment of older adults.

Control group (C-GR)

Eligibility Criteria

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

You may qualify if:

• With 60-75 years of age.
• They have self-reported cognitive concerns (ie, have answered "yes" to the question: "Do you feel like your memory or thinking skills have gotten worse recently?").
• They demonstrate functional independence in activities of daily living and instrumental activities of daily living.
• They have one or more vascular risk factors (eg, type 2 diabetes or hypertension).
• They have symptoms or signs of underlying cognitive dysfunction without a diagnosis of dementia (ie, confirmed by a review of their health records and a Mini Mental State Exam \[MMSE\] score\> 24).
• They have an informal caregiver who accepts to participate.

You may not qualify if:

• With depression (score\> 15 according to the Center for Epidemiological Studies Depression Scale - Revised \[CESD-R\]).
• With clinically significant neurological or psychiatric disorders (eg, Parkinson's, schizophrenia).
• With a recent severe cardiovascular event (eg, myocardial infarction, stroke).
• With a major orthopedic condition (eg, severe osteoarthritis).
• With blood pressure that is unsafe for exercise (ie,\> 180/100 mmHg or \<100/60 mmHg).
• With a severe visual or auditory impairment.
• With an unwillingness to adhere to the intervention schedules.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• School of Health and Sport Sciences, Chukyo University, Japan.: collaborator
• Facultad de Estudios Superiores Aragón UNAM: collaborator
• university of chukyo: collaborator
• Faculty of Higher Studies UNAM: collaborator

Study Sites (1)

Rosalinda Sánchez Arenas

Mexico City, 06720, Mexico

Location

Related Publications (42)

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Related Links

• Instituto Mexicano del Seguro Social. Informe al Ejecutivo Federal y al Congreso de la Unión Sobre la situación financiera y los riesgos del Instituto Mexicano del Seguro Social 2017-2018.
• Prueba de caminata de 6 minutos: recomendaciones y procedimientos.
• Consejo Nacional de Población. La situación demográfica de México 2017 (text in Spanish).
• Envejecimiento y dependencia. Realidades y previsión para los próximos años.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Movement

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rosalinda Sánchez Arenas, PhD

  Instituto Mexicano del Seguro Socil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To ensure that the groups are balanced regarding varying levels of education, study participants were not stratified and randomly allocated in blocks of four to one of the intervention groups or the control group. An independent researcher who will not participate in the study will use the Random Allocation Software to generate the allocation sequence.31 Each stratum will have its own seed. This researcher will generate uniform random integers to create the allocation order within each block. She will hold the randomization file on her computer and will give out the allocations of individual participants one at a time to the three groups. The allocations will be concealed from participants and the study staff involved in enrollment and baseline evaluation. The recruitment and application of the intervention for groups 1 and 2 in stages, first in Care Unit 1 and then in Care Unit 10.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator in Epidemiology

Model Details: A double-blind randomized clinical trial entitled "Mind and Movement: Towards the Cognitive Health of Older Adults" will be conducted. The study will include two intervention groups and one control group: (1) a double-task exercise program with a squared mat led by a coach (a health professional) for 24 weeks (T1-GR); (2) the same exercise program led by a coach (a health professional) for 12 weeks and then led by caregivers of older adults for another 12 weeks (T2-GR); and (3) a control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 28, 2019
• Study Start: May 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)