Double-task Exercise Programs to Strengthen Cognitive and Vascular Health in Older Adults at Risk of Cognitive Decline: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- General Cognitive funtion
研究概览
简要总结
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.
详细描述
- Aim: to evaluate two 24-week double-task (aerobic and cognitive) square-stepping exercise programs for older adults (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 75 years of age with self-reported cognitive concerns will participate. They will be stratified by education level and randomly allocated to the groups.
- Study design: 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 hypothesis:
The investigators hypothesize that T1 and T2 double-task exercise trainings will show more significant improvements in older adults than the control aerobic training with regards to (i) general cognitive function; (ii) specific cognitive functions (executive function, processing speed, verbal learning and memory, and verbal fluency); (iii) usual walking and dual-task gait; (iv) blood pressure; (v) carotid intima-media thickness; (vi) carotid arterial compliance; (vii) older adults' health-related quality of life; and (viii) caregiver burden. 4. Sample Size: It was calculated using the formula suggested by Zong (2009)32 for continuous outcome variable and non-inferiority design (2 [Z 1-α+Z 1-β/ δ] * S2). The investigators considered α <0.05, a power of 80%, and the assumptions to δ0 (a clinically acceptable margin) and S2(polled standard deviations of both comparison groups): General cognitive function=0.20(0.05), Mental flexibility (EF) part A=0.13(0.03) and B=0.37(0.37), Processing speed=0.06(0.02), Verbal learning=0.63(0.32) and memory=0.16(0.08), Verbal fluency words by category= 0.54 (0.14) and by letter=0.66 (0.17), Walking speed (cm/s)=0.23(0.06), Walking length(cm)=0.86(0.22), Systolic blood pressure(mmHg)=0.27(0.06); Diastolic blood pressure(mmHg)=0.79(0.40), Carotid intima-media thickness(mm)=0.20(0.05).Subjective burden on informal caregivers=0.53, Patient health-related quality of life (SF-36) Mental score=4.0(1.0) and Physical score=4.0(2.0). The maximum required sample size, assuming a possible 20% drop-out rate, is 85 participants per group. 5. Intervention implementation:
The study will be conducted at IMSS Epidemiology and Health Services Research Unit facilities in Mexico City.
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).
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. 6. Compliance and adverse events monitoring A monitoring system will be developed to perform long-distance monitoring of compliance with physical activity. It will include three components: i) the system that will collect the information from a chipset connected to the SSE mats (e.g., time of exercise, velocity); ii) the system that will transmit and store the data on the study computer; iii) the system for supervision and follow-up, which will allow connecting with participants through different electronic devices, such as mobile phones and e-mails.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group (C-GR)
Control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).
干预措施: "Mind and Movement for Cognitive Health in the Older Adult" (Other)
Control group (C-GR)
Control group of an aerobic-balance-stretching exercise program led by a coach for 24 weeks (C-GR).
干预措施: Double-task exercise by older adults and their caregivers (Other)
T1-GR training sessions by health professional
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).
干预措施: Control excercise (Other)
T2-GR 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.
干预措施: Control excercise (Other)
结局指标
主要结局
General Cognitive funtion
时间窗: 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
时间窗: 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
时间窗: 52 weeks
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
General Cognitive funtion
时间窗: 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
时间窗: 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.
Specific domains of cognitive function
时间窗: 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
时间窗: 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.
Cognitive reserve
时间窗: 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
时间窗: 24 weeks
Capacity that enables an individual to cope with and/or recover from the impact of a neural injury or a psychotic episode.
次要结局
- Usual walking and dual-task gait(52 weeks)
- Carotid intima-media thickness (cIMT)(52 weeks)
- Quality of life as measured by SF-12(52 weeks)
- Subjective Caregiver Burden(52 weeks)
- Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin(52 weeks)
- Holter(52 weeks)
- Usual walking and dual-task gait(0 weeks)
- Usual walking and dual-task gait(24 weeks)
- Carotid intima-media thickness (cIMT)(0 weeks)
- Carotid intima-media thickness (cIMT)(24 weeks)
- Quality of life as measured by SF-12(0 weeks)
- Quality of life as measured by SF-12(24 weeks)
- Subjective Caregiver Burden(0 weeks)
- Subjective Caregiver Burden(24 weeks)
- Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin(0 weeks)
- Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin(24 weeks)
- Holter(0 weeks)
- Holter(24 weeks)
研究者
Dr. Rosalinda Sanchez Arenas
Investigator in Epidemiology
Instituto Mexicano del Seguro Social