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Trial record 1 of 1 for:    NCT02136368
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Body and Brain Exercise for Older Adults With Memory Complaints

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ClinicalTrials.gov Identifier: NCT02136368
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : September 7, 2016
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rob Petrella, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE April 29, 2014
First Posted Date  ICMJE May 13, 2014
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2014)
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks [ Time Frame: 6 months ]
To assess global cognitive function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks [ Time Frame: 12 months ]
    To assess global cognitive function
  • Gait variability (stride time) under dual-task conditions [ Time Frame: 6 & 12 months ]
    Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100). Measured with GAITRite system.
  • Gait variability (stride time) under single-task conditions [ Time Frame: 6 & 12 months ]
    Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100). Measured with GAITRite system.
  • Gait velocity (speed) under dual-task conditions [ Time Frame: 6 & 12 months ]
    Average walking speed (gait velocity) measured with the GAITRite system
  • Gait velocity (speed) under single-task conditions [ Time Frame: 6 & 12 months ]
    Average walking speed (gait velocity) measured with the GAITRite system
  • Step length (average) under dual-task conditions [ Time Frame: 6 & 12 months ]
    Mean step length calculated from GAITRite system
  • Step length (average) under single-task conditions [ Time Frame: 6 & 12 months ]
    Mean step length calculated from GAITRite system
  • Carotid Artery Compliance [ Time Frame: 6 & 12 months ]
    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
  • Carotid Artery Intima-media thickness [ Time Frame: 6 & 12 months ]
    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
  • Ambulatory Systolic Blood Pressure [ Time Frame: 6 & 12 months ]
    Average systolic blood pressure over a 24 hour time period.
  • Clinic Systolic Blood Pressure [ Time Frame: 6 & 12 months ]
    Average systolic blood pressure from in clinic final 2 (out of 3) readings
  • Ambulatory Diastolic Blood Pressure [ Time Frame: 6 & 12 months ]
    Average diastolic blood pressure over a 24 hour time period.
  • Clinic Diastolic Blood Pressure [ Time Frame: 6 & 12 months ]
    Average diastolic blood pressure from in clinic final 2 (out of 3) readings
  • Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 6 & 12 months ]
  • Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 6 & 12 months ]
  • Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 6 & 12 months ]
  • Total balance score [ Time Frame: 6 & 12 months ]
    Total score calculated from the the Fullerton Advanced Balance scale
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2014)
  • Coefficient of variation of stride time and step length [ Time Frame: 6 months ]
    Calculated from gait during dual task. (I.e. walking and answering questions).
  • Carotid Artery Compliance [ Time Frame: 6 months ]
    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
  • Ambulatory Systolic Blood Pressure [ Time Frame: 6 months ]
    Average systolic blood pressure over a 24 hour time period.
  • Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 6 months ]
  • Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery. [ Time Frame: 6 months ]
  • Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 6 months ]
  • Gait Velocity [ Time Frame: 6 months ]
  • Ambulatory Diastolic Blood Pressure [ Time Frame: 6 months ]
    Average diastolic blood pressure over a 24 hour time period.
  • Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks [ Time Frame: 12 months ]
  • Coefficient of variation of stride time and step length [ Time Frame: 12 months ]
    Calculate from gait during dual task. (I.e. walking and answering questions).
  • Carotid Artery Compliance [ Time Frame: 12 months ]
    Measured from non-invasive vascular assessment with B-mode Ultrasound over teh carotid artery (in the neck).
  • Ambulatory Systolic Blood Pressure [ Time Frame: 12 months ]
    Average systolic blood pressure over a 24 hour time period.
  • Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 12 months ]
  • Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery. [ Time Frame: 12 months ]
  • Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery [ Time Frame: 12 months ]
  • Gait Velocity [ Time Frame: 12 months ]
  • Ambulatory Diastolic Blood Pressure [ Time Frame: 12 months ]
    Average diastolic blood pressure over a 24 hour time period.
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2014)
  • Prosaccade reaction time in response to flash of light. [ Time Frame: 6 months ]
    The reaction time of the eye when instructed to look toward a flash of light.
  • Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task. [ Time Frame: 6 months ]
    Neuroimaging assessment with functional magnetic resonance imaging
  • Antisaccade reaction time in response to flash of light. [ Time Frame: 6 months ]
    The reaction time of the eye when instructed to look away from a flash of light.
  • Change in blood flow to the parietal cortex in response to a randomly selected cognitive task. [ Time Frame: 6 months ]
    Neuroimaging assessment with functional magnetic resonance imaging
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Body and Brain Exercise for Older Adults With Memory Complaints
Official Title  ICMJE A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study
Brief Summary The purpose of this study is to investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.
Detailed Description

Older adults with self-reported cognitive complaints (CCs) may be at increased risk for the development of Alzheimer's disease and dementia. Cognitive decline in older adults, particularly reduced memory and executive function is associated with functional decline, institutionalization, and increased health care costs. Similarly, cardiovascular risk factors have been associated with cognitive and functional impairment in aging. Aerobic exercise has been shown to improve vascular function and blood flow in the brain's prefrontal cortex. In turn, resistance training can produce functional changes within distinct cortical regions during the encoding and recall of association tasks and has been shown to increase circulating neural growth factors (i.e., a proposed mechanism by which cognition may be preserved or improved in old age). Recent evidence also suggests that cognitive training may improve the cognitive performance of older adults.

Therefore, we will investigate the impact of a combined exercise program (multi-modality exercise; M2) compared to a combined exercise program with a cognitive component (multi-modality, mind-motor exercise; M4) on cognition, cognitive-motor, mobility, neural functioning and vascular outcomes in older adults with cognitive complaints. Community-based exercise programs for older adults provide widespread access, are relatively inexpensive, and provide opportunities for social interaction.

The primary purpose of this study is to compare the effects of the M2 and M4 exercise programs on brain health. This study will also examine the effects of the different exercise programs on cardiovascular risk factors and mobility. In a subset of participants, cognitive-motor and neural functioning outcomes will be examined.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cognitive Ability, General
Intervention  ICMJE
  • Behavioral: Multi-modal exercise
    Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)
    Other Name: Exercise intervention
  • Behavioral: Mind-Motor Exercise
    Square Step Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids (15 min).
    Other Name: Square Stepping Exercise
  • Behavioral: Balance and range of motion exercises
    Community-based group exercise designed to improve balance and range of motion of the joints (15 min)
Study Arms  ICMJE
  • Experimental: Multi-Modal, Mind Motor Exercise (M4)
    Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of mind-motor exercise.
    Interventions:
    • Behavioral: Multi-modal exercise
    • Behavioral: Mind-Motor Exercise
  • Active Comparator: Multi-Modal Exercise (M2)
    Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of balance and range of motion exercises.
    Interventions:
    • Behavioral: Multi-modal exercise
    • Behavioral: Balance and range of motion exercises
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2016)
127
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2014)
140
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged 55 years or older
  • self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).
  • independent on instrumental activities of daily living

Exclusion Criteria:

  • Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score <24)
  • Other neurological conditions or major psychiatric disorders (i.e., Parkinson's disease; bipolar disorder)
  • Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke <1-year ago; end stage congestive heart failure; end stage renal disease)
  • Severe sensory impairment (i.e., blind)
  • Significant orthopedic conditions (i.e., severe osteoarthritis)
  • Clinical depression (determined via >=16 on the Center for Epidemiologic Studies - Depression Scale AND review by primary study physician)
  • Have blood pressure >180/100 mmHg or <100/60 mmHg
  • Unable to comprehend questionnaire material
  • Any other factors that could potentially limit ability to fully participate in the intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02136368
Other Study ID Numbers  ICMJE M4W18858
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rob Petrella, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Robert J Petrella, MD, PhD University of Western Ontario, Canada
PRS Account Lawson Health Research Institute
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP