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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment
• Intervention / Treatment: Behavioral: Exercise Intervention; Behavioral: Exercise Control

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 5J1
      • Aging, Rehabilitation and Geriatric Care Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention Group; 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; 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.; Other Names: Aerobic exercise and dual-task training
Active Comparator: Exercise Control group; 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; 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.; 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

Collaborators and Investigators

• Sponsor: Parkwood Hospital, London, Ontario
• Collaborators: Canadian Institutes of Health Research (CIHR); University of Western Ontario, Canada
• Investigators: Principal Investigator: Robert J Petrella, MD., PhD., Lawson Health Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Aerobic exercise; Cognition; Older adults; Gait Training; Dual Task; Group-based exercise
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: DAE-1234