Control excercise"Mind and Movement for Cognitive Health in the Older Adult"Double-task exercise by older adults and their caregivers
Control excercise: 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).
"Mind and Movement for Cognitive Health in the Older Adult": 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).
Double-task exercise by older adults and their caregivers: 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.
Study 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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
65 Years
Healthy volunteers
No
Inclusion criteria.
1. With 60-75 years of age.
2. 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?").
3. They demonstrate functional independence in activities of daily living and instrumental activities of daily living.
4. They have one or more vascular risk factors (eg, type 2 diabetes or hypertension).
5. 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).
6. They have an informal caregiver who accepts to participate.
Exclusion criteria.
1. With depression (score\> 15 according to the Center for Epidemiological Studies Depression Scale - Revised \[CESD-R\]).
2. With clinically significant neurological or psychiatric disorders (eg, Parkinson's, schizophrenia).
3. With a recent severe cardiovascular event (eg, myocardial infarction, stroke).
4. With a major orthopedic condition (eg, severe osteoarthritis).
5. With blood pressure that is unsafe for exercise (ie,\> 180/100 mmHg or \<100/60 mmHg).
6. With a severe visual or auditory impairment.
7. With an unwillingness to adhere to the intervention schedules.
Primary outcome measure(s)
General Cognitive funtion — 0 weeks 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.
General Cognitive funtion — 24 weeks 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.
General Cognitive funtion — 52 weeks 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.
Specific domains of cognitive function — 0 weeks 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)
Specific domains of cognitive function — 24 weeks 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.
Specific domains of cognitive function — 52 weeks 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.
Cognitive reserve — 0 weeks Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Cognitive reserve — 24 weeks Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Cognitive reserve — 52 weeks Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
Trial sites (1)
Facility
City
Region
Status
Rosalinda Sánchez Arenas
Mexico City
Mexico
More Instituto Mexicano del Seguro Social trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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