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Completed

NCT Number: NCT01572311

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

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aging, Rehabilitation and Geriatric Care Research Center

London, Ontario, N6C 5J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

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

Exercise Control

Behavioral

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

Primary outcomes

  1. Global cognitive functioning

    Time frame: 26 weeks

    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 outcomes

  1. Global cognitive functioning

    Time frame: 12 & 52 weeks

    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.

  2. Executive Function/Mental Flexibility

    Time frame: 12, 26, and 52 weeks

    Standardized scores from seconds to complete Trail Making Test Part A and Trail Making Test Part B averaged to create this standardized composite score

  3. Processing Speed

    Time frame: 12, 26 and 52 weeks

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

  4. Verbal Learning and Memory

    Time frame: 12, 26 and 52 weeks

    Standardized scores from Auditory Verbal Learning Test (number of words learned and number of words recalled) were averaged to create this standardized composite score

  5. Verbal Fluency

    Time frame: 12, 26 and 52 weeks

    Standardized scores from semantic (number of animals) and phonemic (number of words starting with C) were averaged to create this standardized composite score

  6. Gait variability (step length) under dual-task conditions

    Time frame: 12, 26 and 52 weeks

    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.

  7. Gait variability (step length) under single-task conditions

    Time frame: 12, 26 and 52 weeks

    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.

  8. Gait speed under dual-task conditions

    Time frame: 12, 26 and 52 weeks

    Average walking speed measured with GAITRite system

  9. Gait speed under single-task conditions

    Time frame: 12, 26 and 52 weeks

    Average walking speed measured with GAITRite system

  10. Double support (seconds and % gait cycle time) under dual-task conditions

    Time frame: 12, 26 and 52 weeks

    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

  11. Double support (seconds and % gait cycle time) under single-task conditions

    Time frame: 12, 26 and 52 weeks

    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. Step length under dual-task conditions

    Time frame: 12, 26 and 52 weeks

    Mean step length measured with GAITRite system

  13. Step length under single-task conditions

    Time frame: 12, 26 and 52 weeks

    Mean step length measured with GAITRite system

  14. Carotid artery compliance

    Time frame: 12, 26 and 52 weeks

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

  15. Carotid artery Intima-media thickness (IMT)

    Time frame: 12, 26 and 52 weeks

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

  16. Ambulatory systolic blood pressure

    Time frame: 12, 26 and 52 weeks

    Average systolic blood pressure over a 24-hour time frame

  17. Clinic systolic blood pressure

    Time frame: 12, 26 and 52 weeks

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

  18. Ambulatory diastolic blood pressure

    Time frame: 12, 26 and 52 weeks

    Average diastolic blood pressure over a 24-hour time frame

  19. Clinic diastolic blood pressure

    Time frame: 12, 26 and 52 weeks

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

  20. Total balance score

    Time frame: 12, 26, and 52 weeks

    Total balance score calculated from the Fullerton Advanced Balance Scale

  21. Total Falls Self-Efficacy score

    Time frame: 12, 26, and 52 weeks

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

Sponsors and collaborators

Lead sponsor

Parkwood Hospital, London, Ontario

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • University of Western Ontario, Canada

Registry information

Official study title

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

Acronym: HM2

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 6, 2012
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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