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

October 24, 2014 updated by: Robert Petrella, MD, Parkwood Hospital, London, Ontario

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 & 52 weeks
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
12, 26, and 52 weeks
Processing Speed
Time Frame: 12, 26 and 52 weeks
Standardized score from the Digit-Symbol Substitution Test (total correct responses)
12, 26 and 52 weeks
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
12, 26 and 52 weeks
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
12, 26 and 52 weeks
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.
12, 26 and 52 weeks
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.
12, 26 and 52 weeks
Gait speed under dual-task conditions
Time Frame: 12, 26 and 52 weeks
Average walking speed measured with GAITRite system
12, 26 and 52 weeks
Gait speed under single-task conditions
Time Frame: 12, 26 and 52 weeks
Average walking speed measured with GAITRite system
12, 26 and 52 weeks
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
12, 26 and 52 weeks
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, 26 and 52 weeks
Step length under dual-task conditions
Time Frame: 12, 26 and 52 weeks
Mean step length measured with GAITRite system
12, 26 and 52 weeks
Step length under single-task conditions
Time Frame: 12, 26 and 52 weeks
Mean step length measured with GAITRite system
12, 26 and 52 weeks
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)
12, 26 and 52 weeks
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)
12, 26 and 52 weeks
Ambulatory systolic blood pressure
Time Frame: 12, 26 and 52 weeks
Average systolic blood pressure over a 24-hour time frame
12, 26 and 52 weeks
Clinic systolic blood pressure
Time Frame: 12, 26 and 52 weeks
Average systolic blood pressure from final 2 (out of 3) readings
12, 26 and 52 weeks
Ambulatory diastolic blood pressure
Time Frame: 12, 26 and 52 weeks
Average diastolic blood pressure over a 24-hour time frame
12, 26 and 52 weeks
Clinic diastolic blood pressure
Time Frame: 12, 26 and 52 weeks
Average diastolic blood pressure from final 2 (out of 3) readings
12, 26 and 52 weeks
Total balance score
Time Frame: 12, 26, and 52 weeks
Total balance score calculated from the Fullerton Advanced Balance Scale
12, 26, and 52 weeks
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
12, 26, and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Parkwood Hospital, London, Ontario

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert J Petrella, MD., PhD., Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAE-1234

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