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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Parkwood Hospital, London, Ontario
Sponsor:
Collaborators:
University of Western Ontario, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Robert Petrella, MD, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01572311
First received: April 3, 2012
Last updated: April 30, 2013
Last verified: April 2013
  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
Other: Dual task gait training
Other: Aerobic exercise class

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Community Based and Institutional Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults With Cognitive Impairment-no Dementia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to completion of the Trail Making Test-B [ Time Frame: Baseline, change from baseline in TMT-B score at 6 months, change from baseline in TMT-B score at 12 months ] [ Designated as safety issue: No ]
    A "connect the dot" type task that requires one to connect number to letters in ascending order. The test measures executive function and time to completion of the test is the outcome.


Secondary Outcome Measures:
  • Gait Variability [ Time Frame: Baseline, change from baseline at 6 months, change from baseline at 12 months ] [ Designated as safety issue: No ]
    Gait variability is the stride to stride fluctuations of the way someone walks and is calculated as a coefficient of variation from ones average (SD/mean X 100)

  • Average 24-hour ambulatory blood pressure [ Time Frame: Change from baseline at 6 months, Change from baseline at 6 months ] [ Designated as safety issue: No ]
    Average systolic and diastolic blood pressure over a 24 hour period, measured using an ambulatory blood pressure monitor


Estimated Enrollment: 126
Study Start Date: May 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Community-based dual task aerobic exercise
The 75 minute combined exercises program includes: i) a 5 minute warm-up; ii) 20 minutes of moderate-intensity AE within target heart zones of 65-80% of age-predicted maximum heart rate; iii) 5 minute AE cool-down; iv) 20 minutes of strength training of large muscle groups; v) 10 minutes of core strengthening; vi) 5 minutes of balance training; and vii) 10 minutes of stretching. Following the standard program described above, participants will then continue 15 minutes of dual-task gait training exercises. During the dual-task gait training, subjects will be required to walk on a special mat with a designated walking pattern while answering questions such as naming animals aloud, counting backwards, and simple arithmetic. A trained fitness instructor will supervise the sessions which will occur 3 times a week for 6 months.
Other: Dual task gait training
During the dual task training, subjects will be required to walk on a special mat with a designated walking pattern while answering questions such as naming animals aloud, counting backwards, and simple arithmetic.
Active Comparator: Community-based aerobic exercise
The 75 minute combined exercises program includes: i) a 5 minute warm-up; ii) 20 minutes of moderate-intensity AE within target heart zones of 65-80% of age-predicted maximum heart rate; iii) 5 minute AE cool-down; iv) 20 minutes of strength training of large muscle groups; v) 10 minutes of core strengthening; vi) 5 minutes of balance training; and vii) 10 minutes of stretching. Following the standard program described above, participants will then continue 15 minutes of gait training exercises in which they will be required to walk on a special mat with a designated walking pattern. This will not include any dual-task challenges. A trained fitness instructor will supervise the sessions which will occur 3 times a week for 6 months.
Other: Aerobic exercise class
Participants will be a part of a group-based exercise group that incorporates flexibility, aerobic exercise, strength/balance, and gait training (without the addition of a dual-task)
Experimental: Institutional-based dual task aerobic exercise
Participants will exercise on a treadmill (Biodex Gait Trainer) in a hospital setting. The exercise will take place 3 times a week for 6 months. Subjects will begin with a 5-minute warm-up leading into 15 minutes of dual task gait training, which involves walking at a comfortable pace while receiving visual feedback about proper foot placement on the treadmill. At the same time they will also be asked to answer questions such as naming objects aloud, counting backwards, and simple arithmetic while they continue to walk. Following the dual task gait training subjects will engage in 15 minutes of aerobic exercise. There will be no step length feedback or answering of questions during this stage. A 5-minute cool down will follow
Other: Dual task gait training
The dual-task gait training, involves walking at a comfortable pace while receiving visual feedback about proper foot placement on the treadmill. At the same time subjects will also be asked to answer questions such as naming objects aloud, counting backwards, and simple arithmetic while they walk.

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 two groups receiving dual-task aerobic exercise programs, one based in a rehabilitation hospital, and one based in the community, to a control group receiving group-based aerobic exercise in the community. This study will determine whether a dual-task aerobic exercise program is both feasible and effective for improving cognitive and mobility status, as well as vascular compliance, in older adults at risk for cognitive and mobility decline.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/Female 60-85 years old.
  • Cognitive Impairment - No Dementia (CIND) based on Montreal Cognitive Assessment (MoCA) score <26, and Mini Mental State Examination (MMSE) score of >24.
  • Preserved Instrumental Activities of Daily Living (based on Lawton-Brody Instrumental Activities of Daily Living Sale)

Exclusion Criteria:

  • Significant neurological conditions (i.e., Parkinson's or stroke)
  • Previous history of severe CV conditions (i.e., myocardial infarction, end stage renal disease, end stage congestive heart failure).
  • Dementia (i.e., MMSE score <24)
  • Unable to comprehend questionnaire material
  • Significant orthopedic condition (i.e., severe osteoarthritis)
  • Have blood pressure >180/100 mmHg or <100/60 mmHg
  • Clinical Depression (on current treatment or >15 on the Center for Epidemiologic Studies - Depression Scale)
  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

Contacts
Contact: Dawn P Gill, PhD (519) 685-4292 ext 42629 Dawn.Gill@sjhc.london.on.ca

Locations
Canada, Ontario
Aging, Rehabilitation and Geriatric Care Research Center Recruiting
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, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01572311     History of Changes
Other Study ID Numbers: DAE-1234
Study First Received: April 3, 2012
Last Updated: April 30, 2013
Health Authority: Canada: Health Science Research Ethics Board, Western University

Keywords provided by Parkwood Hospital, London, Ontario:
Aerobic exercise
Executive function
Dual Task
Gait Training
Cognitive Impairment - No Dementia

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014