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

This study has been completed.
Sponsor:
Collaborators:
University of Western Ontario, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Robert Petrella, MD, Parkwood Hospital, London, Ontario
ClinicalTrials.gov Identifier:
NCT01572311
First received: April 3, 2012
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Cognitive Impairment
Behavioral: Exercise Intervention
Behavioral: Exercise Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia

Resource links provided by NLM:


Further study details as provided by Parkwood Hospital, London, Ontario:

Primary Outcome Measures:
  • Global cognitive functioning [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 & 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26, and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Standardized score from the Digit-Symbol Substitution Test (total correct responses)

  • Verbal Learning and Memory [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Average walking speed measured with GAITRite system

  • Gait speed under single-task conditions [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Average walking speed measured with GAITRite system

  • Double support (seconds and % gait cycle time) under dual-task conditions [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Mean step length measured with GAITRite system

  • Step length under single-task conditions [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Mean step length measured with GAITRite system

  • Carotid artery compliance [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)

  • Carotid artery Intima-media thickness (IMT) [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)

  • Ambulatory systolic blood pressure [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Average systolic blood pressure over a 24-hour time frame

  • Clinic systolic blood pressure [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Average systolic blood pressure from final 2 (out of 3) readings

  • Ambulatory diastolic blood pressure [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Average diastolic blood pressure over a 24-hour time frame

  • Clinic diastolic blood pressure [ Time Frame: 12, 26 and 52 weeks ] [ Designated as safety issue: No ]
    Average diastolic blood pressure from final 2 (out of 3) readings

  • Total balance score [ Time Frame: 12, 26, and 52 weeks ] [ Designated as safety issue: No ]
    Total balance score calculated from the Fullerton Advanced Balance Scale

  • Total Falls Self-Efficacy score [ Time Frame: 12, 26, and 52 weeks ] [ Designated as safety issue: No ]
    Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale


Enrollment: 44
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Aerobic exercise and gait training

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

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572311

Locations
Canada, Ontario
Aging, Rehabilitation and Geriatric Care Research Center
London, Ontario, Canada, N6C 5J1
Sponsors and Collaborators
Parkwood Hospital, London, Ontario
University of Western Ontario, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Robert J Petrella, MD., PhD. Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Robert Petrella, MD, Principal Investigator, Parkwood Hospital, London, Ontario
ClinicalTrials.gov Identifier: NCT01572311     History of Changes
Other Study ID Numbers: DAE-1234
Study First Received: April 3, 2012
Last Updated: October 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Parkwood Hospital, London, Ontario:
Aerobic exercise
Cognition
Dual Task
Gait Training
Group-based exercise
Older adults

ClinicalTrials.gov processed this record on March 26, 2015