Dual Task Aerobic Exercise for Older Adults With Cognitive Impairment (HM2)

Study Overview
=================
Brief Summary
-----------------
The investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.

Detailed Description
-----------------
To determine the effects of dual-task aerobic exercise training on community dwelling older adults with early signs of cognitive impairment. We will compare an exercise intervention (E-I) versus an exercise control (E-C) group. Each week, both groups will accumulate a minimum of 120 minutes of exercise (target 150 minutes) from community-based group classes (50 minutes of aerobic exercise) and also complete 45 minutes of beginner-level Square Stepping Exercise (SSE). The E-I group will also answer cognitively challenging questions while doing SSE (dual-task training). This study will determine whether a combined multiple modality (primary component being aerobic exercise) and dual-task exercise program is both feasible and effective for improving cognitive and mobility status, as well as vascular compliance, in older adults who may be at risk for cognitive and mobility decline.

Official Title
-----------------
Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia

Conditions
-----------------
Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: Exercise Intervention
* Behavioral: Exercise Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female 55-90 years old. Montreal Cognitive Assessment score ≤27 Preserved Instrumental Activities of Daily Living (based on Lawton-Brody Instrumental Activities of Daily Living Sale) Exclusion Criteria: Dementia (i.e., Mini-Mental Examination score <24 or self-reported physician diagnosis) Major Depression (>=16 on the Center for Epidemiologic Studies - Depression Scale combined with clinical judgment by primary study physician) Other neurological or psychiatric disorders Recent history of severe cardiovascular conditions Significant orthopedic conditions Have blood pressure >180/100 mmHg or <100/60 mmHg Unable to comprehend questionnaire material/study procedures

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention Group<br>For 26 weeks, attend Canadian Centre for Activity and Aging combined classes (75-minute or 60-minute classes, 2 to 3 days/week) and also complete 45 minutes of dual-task gait training (15 minutes for 3 days/week or 22.5 minutes for 2 days/week) | Behavioral: Exercise Intervention<br>* Goal of 150 minutes of structured exercise/week; minimum of 120 minutes from CCAA classes/week. The 75-minute class includes: 5-minute warm-up; 25 minutes of AE (70-85% maximum heart rate); 5-minute cool-down; 20 minutes of strength training; 5 minutes of core strengthening; 5 minutes of balance training; and 10 minutes of stretching. The 60-minute program is identical except: 15 minutes total for all strength training (including core) and 5 minutes of stretching. Following CCAA classes, participants continue with dual-task gait training where they are required to walk on a special mat with a designated walking pattern (beginner level Square Stepping Exercise) while answering cognitively challenging questions.<br>* Other names: Aerobic exercise and dual-task training;|
| Active Comparator: Exercise Control group<br>For 26 weeks, attend Canadian Centre for Activity and Aging combined classes (75-minute or 60-minute classes, 2 to 3 days/week) and also complete 45 minutes of gait training (15 minutes for 3 days/week or 22.5 minutes for 2 days/week). Note: no dual-task challenges during gait training | Behavioral: Exercise Control<br>* Goal of 150 minutes of structured exercise/week; minimum of 120 minutes from CCAA classes/week. The 75-minute class includes: 5-minute warm-up; 25 minutes of AE (70-85% maximum heart rate); 5-minute cool-down; 20 minutes of strength training; 5 minutes of core strengthening; 5 minutes of balance training; and 10 minutes of stretching. The 60-minute program is identical except: 15 minutes total for all strength training (including core) and 5 minutes of stretching. Following CCAA classes, participants continue with gait training where they are required to walk on a special mat with a designated walking pattern (beginner level Square Stepping Exercise). This will not include any dual-task challenges.<br>* Other names: Aerobic exercise and gait training;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognitive functioning | Four standardized domain-specific composite scores were averaged to create this standardized global cognitive functioning score (incorporates executive function, processing speed, verbal learning and memory, and verbal fluency. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognitive functioning | Four standardized domain-specific composite scores were averaged to create this standardized global cognitive functioning score (incorporates executive function, processing speed, verbal learning and memory, and verbal fluency. | 12 & 52 weeks | 
| Executive Function/Mental Flexibility | Standardized scores from seconds to complete Trail Making Test Part A and Trail Making Test Part B averaged to create this standardized composite score | 12, 26, and 52 weeks | 
| Processing Speed | Standardized score from the Digit-Symbol Substitution Test (total correct responses) | 12, 26 and 52 weeks | 
| Verbal Learning and Memory | Standardized scores from Auditory Verbal Learning Test (number of words learned and number of words recalled) were averaged to create this standardized composite score | 12, 26 and 52 weeks | 
| Verbal Fluency | Standardized scores from semantic (number of animals) and phonemic (number of words starting with C) were averaged to create this standardized composite score | 12, 26 and 52 weeks | 
| Gait variability (step length) under dual-task conditions | Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as coefficient of variation of step length (SD/mean x 100). Measured with GAITRite system. | 12, 26 and 52 weeks | 
| Gait variability (step length) under single-task conditions | Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as coefficient of variation of step length (SD/mean x 100). Measured with GAITRite system. | 12, 26 and 52 weeks | 
| Gait speed under dual-task conditions | Average walking speed measured with GAITRite system | 12, 26 and 52 weeks | 
| Gait speed under single-task conditions | Average walking speed measured with GAITRite system | 12, 26 and 52 weeks | 
| Double support (seconds and % gait cycle time) under dual-task conditions | Initial double support occurs from heel contact of one footfall to toe-off of the opposite footfall. Terminal double support occurs from opposite footfall heel strike to support footfall toe-off.Total double support is the sum of the initial double support added to the terminal double support. It is measured in seconds (sec) and also expressed as a percent of the Gait Cycle time for the same foot. Measured with GAITRite system | 12, 26 and 52 weeks | 
| Double support (seconds and % gait cycle time) under single-task conditions | Initial double support occurs from heel contact of one footfall to toe-off of the opposite footfall. Terminal double support occurs from opposite footfall heel strike to support footfall toe-off.Total double support is the sum of the initial double support added to the terminal double support. It is measured in seconds (sec) and also expressed as a percent of the Gait Cycle time for the same foot. Measured with GAITRite system | 12, 26 and 52 weeks | 
| Step length under dual-task conditions | Mean step length measured with GAITRite system | 12, 26 and 52 weeks | 
| Step length under single-task conditions | Mean step length measured with GAITRite system | 12, 26 and 52 weeks | 
| Carotid artery compliance | Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck) | 12, 26 and 52 weeks | 
| Carotid artery Intima-media thickness (IMT) | Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck) | 12, 26 and 52 weeks | 
| Ambulatory systolic blood pressure | Average systolic blood pressure over a 24-hour time frame | 12, 26 and 52 weeks | 
| Clinic systolic blood pressure | Average systolic blood pressure from final 2 (out of 3) readings | 12, 26 and 52 weeks | 
| Ambulatory diastolic blood pressure | Average diastolic blood pressure over a 24-hour time frame | 12, 26 and 52 weeks | 
| Clinic diastolic blood pressure | Average diastolic blood pressure from final 2 (out of 3) readings | 12, 26 and 52 weeks | 
| Total balance score | Total balance score calculated from the Fullerton Advanced Balance Scale | 12, 26, and 52 weeks | 
| Total Falls Self-Efficacy score | Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale | 12, 26, and 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aerobic exercise, Cognition, Dual Task, Gait Training, Group-based exercise, Older adults