Cognitive ImpairmentHM2NCT01572311
Dual Task Aerobic Exercise for Older Adults With Cognitive Impairment (HM2)
A study testing Exercise Intervention in people with Cognitive Impairment, run by Parkwood Hospital, London, Ontario at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Aging, Rehabilitation and Geriatric Care Research Center
London, Ontario, N6C 5J1
About this study
Official title: 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.
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.
- Conditions
- Cognitive Impairment
- Being tested
- Exercise Intervention, Exercise Control
- Keywords
- Aerobic exercise, Cognition, Dual Task, Gait Training, Group-based exercise, Older adults
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Also called Aerobic exercise and dual-task training
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 ControlBehavioural
Also called Aerobic exercise and gait training
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention Group | Experimental | 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) Receives: Behavioral: Exercise Intervention |
| Exercise Control group | Active comparator | 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 Receives: Behavioral: Exercise Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (21)
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.
Measured: 12 & 52 weeks
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
Measured: 12, 26, and 52 weeks
Processing Speed
Standardized score from the Digit-Symbol Substitution Test (total correct responses)
Measured: 12, 26 and 52 weeks
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
Measured: 12, 26 and 52 weeks
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
Measured: 12, 26 and 52 weeks
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.
Measured: 12, 26 and 52 weeks
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.
Measured: 12, 26 and 52 weeks
Gait speed under dual-task conditions
Average walking speed measured with GAITRite system
Measured: 12, 26 and 52 weeks
Gait speed under single-task conditions
Average walking speed measured with GAITRite system
Measured: 12, 26 and 52 weeks
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
Measured: 12, 26 and 52 weeks
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
Measured: 12, 26 and 52 weeks
Step length under dual-task conditions
Mean step length measured with GAITRite system
Measured: 12, 26 and 52 weeks
Step length under single-task conditions
Mean step length measured with GAITRite system
Measured: 12, 26 and 52 weeks
Carotid artery compliance
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)
Measured: 12, 26 and 52 weeks
Carotid artery Intima-media thickness (IMT)
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck)
Measured: 12, 26 and 52 weeks
Ambulatory systolic blood pressure
Average systolic blood pressure over a 24-hour time frame
Measured: 12, 26 and 52 weeks
Clinic systolic blood pressure
Average systolic blood pressure from final 2 (out of 3) readings
Measured: 12, 26 and 52 weeks
Ambulatory diastolic blood pressure
Average diastolic blood pressure over a 24-hour time frame
Measured: 12, 26 and 52 weeks
Clinic diastolic blood pressure
Average diastolic blood pressure from final 2 (out of 3) readings
Measured: 12, 26 and 52 weeks
Total balance score
Total balance score calculated from the Fullerton Advanced Balance Scale
Measured: 12, 26, and 52 weeks
Total Falls Self-Efficacy score
Total falls self-efficiacy score calculated from the Falls Self-Efficacy International (FES-I) scale
Measured: 12, 26, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkwood Hospital, London, Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Robert Petrella, MD, Parkwood Hospital, London, Ontario
- Investigators
- Robert J Petrella, MD., PhD., Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572311
- Sponsor's protocol ID
- DAE-1234
- Acronym
- HM2
- Status last verified
- Oct 2014
- First submitted
- 3 Apr 2012
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Community Based Dual Task and Aerobic Exercise Intervention on Cognition and Mobility in Older Adults Without Dementia
- ClinicalTrials.gov ID
- NCT01572311
- Acronym / sponsor ID
- HM2 / DAE-1234
- Conditions
- Cognitive Impairment
- Keywords
- Aerobic exercise, Cognition, Dual Task, Gait Training, Group-based exercise, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Parkwood Hospital, London, OntarioUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Behavioral: Exercise InterventionFor 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) |
| Exercise Control group | Active comparator | Behavioral: Exercise ControlFor 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 |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionAlso: Aerobic exercise and dual-task trainingGoal 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. | Behavioural | Exercise Intervention Group |
| Exercise ControlAlso: Aerobic exercise and gait trainingGoal 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. | Behavioural | Exercise Control group |
Primary outcome
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.
21 secondary outcomes
Global cognitive functioning
Time frame: 12 & 52 weeks
Executive Function/Mental Flexibility
Time frame: 12, 26, and 52 weeks
Processing Speed
Time frame: 12, 26 and 52 weeks
Verbal Learning and Memory
Time frame: 12, 26 and 52 weeks
Verbal Fluency
Time frame: 12, 26 and 52 weeks
Gait variability (step length) under dual-task conditions
Time frame: 12, 26 and 52 weeks
Gait variability (step length) under single-task conditions
Time frame: 12, 26 and 52 weeks
Gait speed under dual-task conditions
Time frame: 12, 26 and 52 weeks
Gait speed under single-task conditions
Time frame: 12, 26 and 52 weeks
Double support (seconds and % gait cycle time) under dual-task conditions
Time frame: 12, 26 and 52 weeks
Double support (seconds and % gait cycle time) under single-task conditions
Time frame: 12, 26 and 52 weeks
Step length under dual-task conditions
Time frame: 12, 26 and 52 weeks
Step length under single-task conditions
Time frame: 12, 26 and 52 weeks
Carotid artery compliance
Time frame: 12, 26 and 52 weeks
Carotid artery Intima-media thickness (IMT)
Time frame: 12, 26 and 52 weeks
Ambulatory systolic blood pressure
Time frame: 12, 26 and 52 weeks
Clinic systolic blood pressure
Time frame: 12, 26 and 52 weeks
Ambulatory diastolic blood pressure
Time frame: 12, 26 and 52 weeks
Clinic diastolic blood pressure
Time frame: 12, 26 and 52 weeks
Total balance score
Time frame: 12, 26, and 52 weeks
Total Falls Self-Efficacy score
Time frame: 12, 26, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Derived from this study: PubMed 26285025Gill 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.
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Petrella, MD., PhD. principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Cognitive Impairment, run by Parkwood Hospital, London, Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive functioning (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.