Clinical trial NCT01572311: Dual Task Aerobic Exercise for Older Adults With Cognitive Impairment (HM2)
Official title: Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: Aerobic exercise
Cognition
Dual Task
Gait Training
Group-based exercise
Older adults
Lead sponsor: Parkwood Hospital, London, Ontario
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-04-06
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Global cognitive functioning
timeFrame: 26 weeks
Secondary outcomes:
measure: Global cognitive functioning
timeFrame: 12 & 52 weeks
measure: Executive Function/Mental Flexibility
timeFrame: 12, 26, and 52 weeks
measure: Processing Speed
timeFrame: 12, 26 and 52 weeks
measure: Verbal Learning and Memory
timeFrame: 12, 26 and 52 weeks
measure: Verbal Fluency
timeFrame: 12, 26 and 52 weeks
measure: Gait variability (step length) under dual-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Gait variability (step length) under single-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Gait speed under dual-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Gait speed under single-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Double support (seconds and % gait cycle time) under dual-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Double support (seconds and % gait cycle time) under single-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Step length under dual-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Step length under single-task conditions
timeFrame: 12, 26 and 52 weeks
measure: Carotid artery compliance
timeFrame: 12, 26 and 52 weeks
measure: Carotid artery Intima-media thickness (IMT)
timeFrame: 12, 26 and 52 weeks
measure: Ambulatory systolic blood pressure
timeFrame: 12, 26 and 52 weeks
measure: Clinic systolic blood pressure
timeFrame: 12, 26 and 52 weeks
measure: Ambulatory diastolic blood pressure
timeFrame: 12, 26 and 52 weeks
measure: Clinic diastolic blood pressure
timeFrame: 12, 26 and 52 weeks
measure: Total balance score
timeFrame: 12, 26, and 52 weeks
measure: Total Falls Self-Efficacy score
timeFrame: 12, 26, and 52 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Aging, Rehabilitation and Geriatric Care Research Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Robert J Petrella, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gill DP, Gregory MA, Zou G, Liu-Ambrose T, Shigematsu R, Hachinski V, Fitzgerald C, Petrella RJ. The Healthy Mind, Healthy Mobility Trial: A Novel Exercise Program for Older Adults. Med Sci Sports Exerc. 2016 Feb;48(2):297-306. doi: 10.1249/MSS.0000000000000758.