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Double-task Exercise in Older Adults at Risk of Cognitive Decline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068376
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : July 28, 2020
Sponsor:
Collaborators:
Universidad Nacional Autonoma de Mexico
Mie University
Information provided by (Responsible Party):
Dr. Rosalinda Sanchez Arenas, Instituto Mexicano del Seguro Social

Brief Summary:
Cerebral small vessel disease is a frequent cause of cognitive disability among older adults (OAs) in Mexico that imposes significant burden on the health system and OAs' families. 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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Vascular Health Other: Control excercise Other: "Mind and Movement for Cognitive Health in the Older Adult" Other: Double-task exercise by older adults and their caregivers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Investigator)
Masking Description: To ensure that the groups are balanced with regard to varying levels of education, study participants will be stratified by education (uncomplete/complete elementary, complete secondary or high education) 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 in 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, the study staff involved in enrollment and baseline evaluation.
Primary Purpose: Prevention
Official Title: Double-task Exercise Programs to Strengthen Cognitive and Vascular Health in Older Adults at Risk of Cognitive Decline: a Randomized Clinical Trial
Estimated Study Start Date : September 2, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group (C-GR)
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"
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).
Other Name: Double-task exercise by a health professional

Other: 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.

Experimental: 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).
Other: 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).
Other Name: Aerobic-balance-stretching exercise program

Experimental: 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.
Other: 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).
Other Name: Aerobic-balance-stretching exercise program




Primary Outcome Measures :
  1. General Cognitive funtion [ Time Frame: 12 weeks ]
    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.

  2. General Cognitive funtion [ Time Frame: 24 weeks ]
    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.

  3. General Cognitive funtion [ Time Frame: 52 weeks ]
    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.

  4. Specific domains of cognitive function [ Time Frame: 12 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.

  5. Specific domains of cognitive function [ Time Frame: 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.

  6. Specific domains of cognitive function [ Time Frame: 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.


Secondary Outcome Measures :
  1. Usual walking and dual-task gait [ Time Frame: 12 weeks ]
    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.

  2. Usual walking and dual-task gait [ Time Frame: 24 weeks ]
    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.

  3. Usual walking and dual-task gait [ Time Frame: 52 weeks ]
    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.

  4. Blood pressure [ Time Frame: 12 weeks ]
    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.

  5. Blood pressure [ Time Frame: 24 weeks ]
    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.

  6. Blood pressure [ Time Frame: 52 weeks ]
    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.

  7. Carotid intima-media thickness (cIMT) [ Time Frame: 12 weeks ]
    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.

  8. Carotid intima-media thickness (cIMT) [ Time Frame: 24 weeks ]
    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.

  9. Carotid intima-media thickness (cIMT) [ Time Frame: 52 weeks ]
    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.

  10. Quality of life as measured by SF-12 [ Time Frame: 12 weeks ]
    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).

  11. Quality of life as measured by SF-12 [ Time Frame: 24 weeks ]
    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. Quality of life as measured by SF-12 [ Time Frame: 52 weeks ]
    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).

  13. Subjective Caregiver Burden [ Time Frame: 12 ]
    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.

  14. Subjective Caregiver Burden [ Time Frame: 24 weeks ]
    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.

  15. Subjective Caregiver Burden [ Time Frame: 52 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria.

  1. With 60-65 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068376


Contacts
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Contact: Rosalinda Sanchez-Arenas, PhD +525556276900 ext 21072 felicitasarenas@gmail.com

Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Universidad Nacional Autonoma de Mexico
Mie University
Investigators
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Study Director: Svetlana Doubova, PhD Instituto Mexicano del Seguro Socil
Additional Information:
Publications of Results:

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Responsible Party: Dr. Rosalinda Sanchez Arenas, Investigator in Epidemiology, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT04068376    
Other Study ID Numbers: 2018-785-095
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Rosalinda Sanchez Arenas, Instituto Mexicano del Seguro Social:
cognitive decline
double task
older adults
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders