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

Cognitive Impairment Clinical Trial

— HM2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572311
• Other study ID #: DAE-1234
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: October 24, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Parkwood Hospital, London, Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Aging, Rehabilitation and Geriatric Care Research Center	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Parkwood Hospital, London, Ontario	Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	26 weeks	No
Secondary	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.	12 & 52 weeks	No
Secondary	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	12, 26, and 52 weeks	No
Secondary	Processing Speed	Standardized score from the Digit-Symbol Substitution Test (total correct responses)	12, 26 and 52 weeks	No
Secondary	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	12, 26 and 52 weeks	No
Secondary	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	12, 26 and 52 weeks	No
Secondary	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.	12, 26 and 52 weeks	No
Secondary	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.	12, 26 and 52 weeks	No
Secondary	Gait speed under dual-task conditions	Average walking speed measured with GAITRite system	12, 26 and 52 weeks	No
Secondary	Gait speed under single-task conditions	Average walking speed measured with GAITRite system	12, 26 and 52 weeks	No
Secondary	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	12, 26 and 52 weeks	No
Secondary	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	12, 26 and 52 weeks	No
Secondary	Step length under dual-task conditions	Mean step length measured with GAITRite system	12, 26 and 52 weeks	No
Secondary	Step length under single-task conditions	Mean step length measured with GAITRite system	12, 26 and 52 weeks	No
Secondary	Carotid artery compliance	Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)	12, 26 and 52 weeks	No
Secondary	Carotid artery Intima-media thickness (IMT)	Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)	12, 26 and 52 weeks	No
Secondary	Ambulatory systolic blood pressure	Average systolic blood pressure over a 24-hour time frame	12, 26 and 52 weeks	No
Secondary	Clinic systolic blood pressure	Average systolic blood pressure from final 2 (out of 3) readings	12, 26 and 52 weeks	No
Secondary	Ambulatory diastolic blood pressure	Average diastolic blood pressure over a 24-hour time frame	12, 26 and 52 weeks	No
Secondary	Clinic diastolic blood pressure	Average diastolic blood pressure from final 2 (out of 3) readings	12, 26 and 52 weeks	No
Secondary	Total balance score	Total balance score calculated from the Fullerton Advanced Balance Scale	12, 26, and 52 weeks	No
Secondary	Total Falls Self-Efficacy score	Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale	12, 26, and 52 weeks	No