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

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Intervention
Exercise Control
Sponsored by
Parkwood Hospital, London, Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring Aerobic exercise, Cognition, Dual Task, Gait Training, Group-based exercise, Older adults

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aging, Rehabilitation and Geriatric Care Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Intervention Group

Exercise Control group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Processing Speed
Standardized score from the Digit-Symbol Substitution Test (total correct responses)
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
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
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.
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.
Gait speed under dual-task conditions
Average walking speed measured with GAITRite system
Gait speed under single-task conditions
Average walking speed measured with GAITRite system
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
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
Step length under dual-task conditions
Mean step length measured with GAITRite system
Step length under single-task conditions
Mean step length measured with GAITRite system
Carotid artery compliance
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)
Carotid artery Intima-media thickness (IMT)
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)
Ambulatory systolic blood pressure
Average systolic blood pressure over a 24-hour time frame
Clinic systolic blood pressure
Average systolic blood pressure from final 2 (out of 3) readings
Ambulatory diastolic blood pressure
Average diastolic blood pressure over a 24-hour time frame
Clinic diastolic blood pressure
Average diastolic blood pressure from final 2 (out of 3) readings
Total balance score
Total balance score calculated from the Fullerton Advanced Balance Scale
Total Falls Self-Efficacy score
Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale

Full Information

First Posted
April 3, 2012
Last Updated
October 24, 2014
Sponsor
Parkwood Hospital, London, Ontario
Collaborators
University of Western Ontario, Canada, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01572311
Brief Title
Dual Task Aerobic Exercise for Older Adults With Cognitive Impairment (HM2)
Acronym
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parkwood Hospital, London, Ontario
Collaborators
University of Western Ontario, Canada, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Aerobic exercise, Cognition, Dual Task, Gait Training, Group-based exercise, Older adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Exercise Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Other Intervention Name(s)
Aerobic exercise and dual-task training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Control
Other Intervention Name(s)
Aerobic exercise and gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global cognitive functioning
Description
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Global cognitive functioning
Description
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.
Time Frame
12 & 52 weeks
Title
Executive Function/Mental Flexibility
Description
Standardized scores from seconds to complete Trail Making Test Part A and Trail Making Test Part B averaged to create this standardized composite score
Time Frame
12, 26, and 52 weeks
Title
Processing Speed
Description
Standardized score from the Digit-Symbol Substitution Test (total correct responses)
Time Frame
12, 26 and 52 weeks
Title
Verbal Learning and Memory
Description
Standardized scores from Auditory Verbal Learning Test (number of words learned and number of words recalled) were averaged to create this standardized composite score
Time Frame
12, 26 and 52 weeks
Title
Verbal Fluency
Description
Standardized scores from semantic (number of animals) and phonemic (number of words starting with C) were averaged to create this standardized composite score
Time Frame
12, 26 and 52 weeks
Title
Gait variability (step length) under dual-task conditions
Description
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.
Time Frame
12, 26 and 52 weeks
Title
Gait variability (step length) under single-task conditions
Description
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.
Time Frame
12, 26 and 52 weeks
Title
Gait speed under dual-task conditions
Description
Average walking speed measured with GAITRite system
Time Frame
12, 26 and 52 weeks
Title
Gait speed under single-task conditions
Description
Average walking speed measured with GAITRite system
Time Frame
12, 26 and 52 weeks
Title
Double support (seconds and % gait cycle time) under dual-task conditions
Description
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
Time Frame
12, 26 and 52 weeks
Title
Double support (seconds and % gait cycle time) under single-task conditions
Description
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
Time Frame
12, 26 and 52 weeks
Title
Step length under dual-task conditions
Description
Mean step length measured with GAITRite system
Time Frame
12, 26 and 52 weeks
Title
Step length under single-task conditions
Description
Mean step length measured with GAITRite system
Time Frame
12, 26 and 52 weeks
Title
Carotid artery compliance
Description
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)
Time Frame
12, 26 and 52 weeks
Title
Carotid artery Intima-media thickness (IMT)
Description
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)
Time Frame
12, 26 and 52 weeks
Title
Ambulatory systolic blood pressure
Description
Average systolic blood pressure over a 24-hour time frame
Time Frame
12, 26 and 52 weeks
Title
Clinic systolic blood pressure
Description
Average systolic blood pressure from final 2 (out of 3) readings
Time Frame
12, 26 and 52 weeks
Title
Ambulatory diastolic blood pressure
Description
Average diastolic blood pressure over a 24-hour time frame
Time Frame
12, 26 and 52 weeks
Title
Clinic diastolic blood pressure
Description
Average diastolic blood pressure from final 2 (out of 3) readings
Time Frame
12, 26 and 52 weeks
Title
Total balance score
Description
Total balance score calculated from the Fullerton Advanced Balance Scale
Time Frame
12, 26, and 52 weeks
Title
Total Falls Self-Efficacy score
Description
Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale
Time Frame
12, 26, and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Petrella, MD., PhD.
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aging, Rehabilitation and Geriatric Care Research Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26285025
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.
Results Reference
derived

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

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