Cognitive Decline Clinical Trial
Official title:
Double-task Exercise Programs to Strengthen Cognitive and Vascular Health in Older Adults at Risk of Cognitive Decline: a Randomized Clinical Trial
Verified date | October 2023 |
Source | Instituto Mexicano del Seguro Social |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | October 1, 2026 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Rosalinda Sánchez Arenas | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Mexicano del Seguro Social | Facultad de Estudios Superiores Aragón UNAM, School of Health and Sport Sciences, Chukyo University, Japan. |
Mexico,
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* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General Cognitive funtion | General cognitive function assessed by the Montreal Cognitive Assessment (MoCA) test on a scale of 0-30 points. Scores are interpreted as follows: >26 indicates no dementia, 18-26 mild cognitive impairment, 6-10 moderate dementia, and <6 severe dementia. | 12 weeks | |
Primary | General Cognitive funtion | General cognitive function assessed by the Montreal Cognitive Assessment (MoCA) test on a scale of 0-30 points. Scores are interpreted as follows: >26 indicates no dementia, 18-26 mild cognitive impairment, 6-10 moderate dementia, and <6 severe dementia. | 24 weeks | |
Primary | General Cognitive funtion | General cognitive function assessed by the Montreal Cognitive Assessment (MoCA) test on a scale of 0-30 points. Scores are interpreted as follows: >26 indicates no dementia, 18-26 mild cognitive impairment, 6-10 moderate dementia, and <6 severe dementia. | 52 weeks | |
Primary | 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. | 12 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Usual walking and dual-task gait | Usual walking and dual-task gait will be evaluated through motion capture during the six-minute walk test (6MWT), which requires participants to walk back and forth across a 30-metre area at a comfortable pace for six minutes. The fixed distance utilized by 6MWT allows determination of gait speed (i.e., v=d/t); however, this test will also be coupled with infrared stride analysis, which will allow for a more precise evaluation of gait speed, stride length, and stride variability under usual and dual-task conditions. These procedures will provide a number of valid and reliable gait outcomes through the synchronization of mobility data via eight infrared cameras, six force plates, and electromyography. | 12 weeks | |
Secondary | Usual walking and dual-task gait | Usual walking and dual-task gait will be evaluated through motion capture during the six-minute walk test (6MWT), which requires participants to walk back and forth across a 30-metre area at a comfortable pace for six minutes. The fixed distance utilized by 6MWT allows determination of gait speed (i.e., v=d/t); however, this test will also be coupled with infrared stride analysis, which will allow for a more precise evaluation of gait speed, stride length, and stride variability under usual and dual-task conditions. These procedures will provide a number of valid and reliable gait outcomes through the synchronization of mobility data via eight infrared cameras, six force plates, and electromyography. | 24 weeks | |
Secondary | Usual walking and dual-task gait | Usual walking and dual-task gait will be evaluated through motion capture during the six-minute walk test (6MWT), which requires participants to walk back and forth across a 30-metre area at a comfortable pace for six minutes. The fixed distance utilized by 6MWT allows determination of gait speed (i.e., v=d/t); however, this test will also be coupled with infrared stride analysis, which will allow for a more precise evaluation of gait speed, stride length, and stride variability under usual and dual-task conditions. These procedures will provide a number of valid and reliable gait outcomes through the synchronization of mobility data via eight infrared cameras, six force plates, and electromyography. | 52 weeks | |
Secondary | Blood pressure | Blood pressure (BP) will be measured as part of the monitoring system. Participants will be provided with an appropriately-sized ambulatory BP monitoring device. BP will be recorded over a 24-hour period: twice in the same hour during daytime hours (i.e., 06:00am-22:00pm) and once during nighttime hours (i.e., 22:00pm-06:00am). Systolic and diastolic BP values will be averaged over the entire 24-hour period and used for analysis. A minimum of 28 successful BP readings out of 40 in total (70%) will be required for statistical analysis. In order to account for external influences on BP, participants will be provided with an activity log and instructed to report the time and type of any stressful or physically demanding situations they experience while wearing the ambulatory BP monitor. | 12 weeks | |
Secondary | Blood pressure | Blood pressure (BP) will be measured as part of the monitoring system. Participants will be provided with an appropriately-sized ambulatory BP monitoring device. BP will be recorded over a 24-hour period: twice in the same hour during daytime hours (i.e., 06:00am-22:00pm) and once during nighttime hours (i.e., 22:00pm-06:00am). Systolic and diastolic BP values will be averaged over the entire 24-hour period and used for analysis. A minimum of 28 successful BP readings out of 40 in total (70%) will be required for statistical analysis. In order to account for external influences on BP, participants will be provided with an activity log and instructed to report the time and type of any stressful or physically demanding situations they experience while wearing the ambulatory BP monitor. | 24 weeks | |
Secondary | Blood pressure | Blood pressure (BP) will be measured as part of the monitoring system. Participants will be provided with an appropriately-sized ambulatory BP monitoring device. BP will be recorded over a 24-hour period: twice in the same hour during daytime hours (i.e., 06:00am-22:00pm) and once during nighttime hours (i.e., 22:00pm-06:00am). Systolic and diastolic BP values will be averaged over the entire 24-hour period and used for analysis. A minimum of 28 successful BP readings out of 40 in total (70%) will be required for statistical analysis. In order to account for external influences on BP, participants will be provided with an activity log and instructed to report the time and type of any stressful or physically demanding situations they experience while wearing the ambulatory BP monitor. | 52 weeks | |
Secondary | Carotid intima-media thickness (cIMT) | Carotid intima-media thickness (cIMT) is the thickness of the two innermost layers of the arterial wall, intima and median in cm and will be measured through an ultrasound of the right common carotid artery. Specifically, a longitudinal B-mode image (Philips HDI 5000 ultrasound, 7-12 MHz linear array transducer) of the cephalic portion of the right common carotid artery will be obtained by a trained ultrasound technician. The composite IMT was calculated as the means of near and far wall IMT of all carotid segments, millimeters. | 12 weeks | |
Secondary | Carotid intima-media thickness (cIMT) | Carotid intima-media thickness (cIMT) is the thickness of the two innermost layers of the arterial wall, intima and median in cm and will be measured through an ultrasound of the right common carotid artery. Specifically, a longitudinal B-mode image (Philips HDI 5000 ultrasound, 7-12 MHz linear array transducer) of the cephalic portion of the right common carotid artery will be obtained by a trained ultrasound technician. The composite IMT was calculated as the means of near and far wall IMT of all carotid segments, millimeters. | 24 weeks | |
Secondary | Carotid intima-media thickness (cIMT) | Carotid intima-media thickness (cIMT) is the thickness of the two innermost layers of the arterial wall, intima and median in cm and will be measured through an ultrasound of the right common carotid artery. Specifically, a longitudinal B-mode image (Philips HDI 5000 ultrasound, 7-12 MHz linear array transducer) of the cephalic portion of the right common carotid artery will be obtained by a trained ultrasound technician. The composite IMT was calculated as the means of near and far wall IMT of all carotid segments, millimeters. | 52 weeks | |
Secondary | Quality of life as measured by SF-12 | Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100). | 12 weeks | |
Secondary | Quality of life as measured by SF-12 | Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100). | 24 weeks | |
Secondary | Quality of life as measured by SF-12 | Older adults' health-related quality of life (QoL) will be measured by the short form (SF-12) of the Medical Outcomes Survey questionnaire, comprised of 12 items. Physical and mental scores will be calculated using an algorithm to convert each item response into standardized values according to specific predetermined weights. Summary scores for each component range from 0-100 and are interpreted as low QoL (close to 0) and high QoL (approaching 100). | 52 weeks | |
Secondary | Subjective Caregiver Burden | Subjective burden on informal caregivers will be measured using the short form of the Burden Scale for Family Caregivers (BSFC-s)-a 10-item instrument. Each item is measured on a four-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). A high degree of agreement indicates higher perception of burden by the caregiver. | 12 weeks | |
Secondary | Subjective Caregiver Burden | Subjective burden on informal caregivers will be measured using the short form of the Burden Scale for Family Caregivers (BSFC-s)-a 10-item instrument. Each item is measured on a four-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). A high degree of agreement indicates higher perception of burden by the caregiver. | 24 weeks | |
Secondary | Subjective Caregiver Burden | Subjective burden on informal caregivers will be measured using the short form of the Burden Scale for Family Caregivers (BSFC-s)-a 10-item instrument. Each item is measured on a four-point scale with the values "strongly disagree" (0), "disagree" (1), "agree" (2), and "strongly agree" (3). A high degree of agreement indicates higher perception of burden by the caregiver. | 52 weeks | |
Secondary | Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin | This is the ability of circulating vascular cell adhesion molecule-1 (VCAM-1), endothelial-leukocyte adhesion molecule-1 (E-selectin), and intercellular adhesion molecule-1 (ICAM-1) to serve as molecular markers of atherosclerosis and predictors of incident cardiovascular disease. | 24 weeks | |
Secondary | Cardiovascular biomarkers and endothelial function: MCP-1, ICAM VCAM and Selectin | This is the ability of circulating vascular cell adhesion molecule-1 (VCAM-1), endothelial-leukocyte adhesion molecule-1 (E-selectin), and intercellular adhesion molecule-1 (ICAM-1) to serve as molecular markers of atherosclerosis and predictors of incident cardiovascular disease. | 52 weeks |
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