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CompletedNCT01572311HM2Updated Oct 28, 2014

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

An interventional study of Exercise Intervention and Exercise Control in Cognitive Impairment, sponsored by Parkwood Hospital, London, Ontario. Completed at 1 site in Canada. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-28.

Sponsored by Parkwood Hospital, London, Ontario · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Impairment

Keywords

  • Aerobic exercise
  • Cognition
  • Dual Task
  • Gait Training
  • Group-based exercise
  • Older adults
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 44 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

This is the only study on the registry with Parkwood Hospital, London, Ontario as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralExercise 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.

    Also known as: Aerobic exercise and dual-task training

  • BehavioralExercise 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.

    Also known as: Aerobic exercise and gait training

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 26 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 & 52 weeks

  2. 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

    Time frame: 12, 26, and 52 weeks

  3. Processing Speed

    Standardized score from the Digit-Symbol Substitution Test (total correct responses)

    Time frame: 12, 26 and 52 weeks

  4. 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

    Time frame: 12, 26 and 52 weeks

  5. 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

    Time frame: 12, 26 and 52 weeks

  6. 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.

    Time frame: 12, 26 and 52 weeks

  7. 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.

    Time frame: 12, 26 and 52 weeks

  8. Gait speed under dual-task conditions

    Average walking speed measured with GAITRite system

    Time frame: 12, 26 and 52 weeks

  9. Gait speed under single-task conditions

    Average walking speed measured with GAITRite system

    Time frame: 12, 26 and 52 weeks

  10. 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

    Time frame: 12, 26 and 52 weeks

  11. 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

    Time frame: 12, 26 and 52 weeks

  12. Step length under dual-task conditions

    Mean step length measured with GAITRite system

    Time frame: 12, 26 and 52 weeks

  13. Step length under single-task conditions

    Mean step length measured with GAITRite system

    Time frame: 12, 26 and 52 weeks

  14. Carotid artery compliance

    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)

    Time frame: 12, 26 and 52 weeks

  15. Carotid artery Intima-media thickness (IMT)

    Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)

    Time frame: 12, 26 and 52 weeks

  16. Ambulatory systolic blood pressure

    Average systolic blood pressure over a 24-hour time frame

    Time frame: 12, 26 and 52 weeks

  17. Clinic systolic blood pressure

    Average systolic blood pressure from final 2 (out of 3) readings

    Time frame: 12, 26 and 52 weeks

  18. Ambulatory diastolic blood pressure

    Average diastolic blood pressure over a 24-hour time frame

    Time frame: 12, 26 and 52 weeks

  19. Clinic diastolic blood pressure

    Average diastolic blood pressure from final 2 (out of 3) readings

    Time frame: 12, 26 and 52 weeks

  20. Total balance score

    Total balance score calculated from the Fullerton Advanced Balance Scale

    Time frame: 12, 26, and 52 weeks

  21. Total Falls Self-Efficacy score

    Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale

    Time frame: 12, 26, and 52 weeks

07

Study locations

1 site
  • Aging, Rehabilitation and Geriatric Care Research Center
    London, Ontario N6C 5J1, Canada
08

References and documents

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. PubMed 26285025 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01572311
Lead sponsor
Parkwood Hospital, London, Ontario
Collaborators
University of Western Ontario, Canada, Canadian Institutes of Health Research (CIHR)
Responsible party
Robert Petrella, MD (Principal Investigator, Parkwood Hospital, London, Ontario) — Principal investigator
First posted
Apr 6, 2012
Start date
Jun 2012
Primary completion
Nov 2013
Completion
May 2014
Last update
Oct 28, 2014

Study contacts

Robert J Petrella, MD., PhD.
principal investigator · London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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