Body and Brain Exercise for Older Adults With Memory Complaints
A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study
1 other identifier
interventional
127
1 country
1
Brief Summary
The purpose of this study is to investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedSeptember 7, 2016
September 1, 2016
1.7 years
April 29, 2014
September 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
To assess global cognitive function
6 months
Secondary Outcomes (17)
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
12 months
Gait variability (stride time) under dual-task conditions
6 & 12 months
Gait variability (stride time) under single-task conditions
6 & 12 months
Gait velocity (speed) under dual-task conditions
6 & 12 months
Gait velocity (speed) under single-task conditions
6 & 12 months
- +12 more secondary outcomes
Other Outcomes (4)
Prosaccade reaction time in response to flash of light.
6 months
Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task.
6 months
Antisaccade reaction time in response to flash of light.
6 months
- +1 more other outcomes
Study Arms (2)
Multi-Modal, Mind Motor Exercise (M4)
EXPERIMENTALAttend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of mind-motor exercise.
Multi-Modal Exercise (M2)
ACTIVE COMPARATORAttend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of balance and range of motion exercises.
Interventions
Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)
Square Step Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids (15 min).
Community-based group exercise designed to improve balance and range of motion of the joints (15 min)
Eligibility Criteria
You may qualify if:
- aged 55 years or older
- self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).
- independent on instrumental activities of daily living
You may not qualify if:
- Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score \<24)
- Other neurological conditions or major psychiatric disorders (i.e., Parkinson's disease; bipolar disorder)
- Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke \<1-year ago; end stage congestive heart failure; end stage renal disease)
- Severe sensory impairment (i.e., blind)
- Significant orthopedic conditions (i.e., severe osteoarthritis)
- Clinical depression (determined via \>=16 on the Center for Epidemiologic Studies - Depression Scale AND review by primary study physician)
- Have blood pressure \>180/100 mmHg or \<100/60 mmHg
- Unable to comprehend questionnaire material
- Any other factors that could potentially limit ability to fully participate in the intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gymnasium
Woodstock, Ontario, N4V 0B1, Canada
Related Publications (2)
Boa Sorte Silva NC, Nagamatsu LS, Gill DP, Owen AM, Petrella RJ. Memory Function and Brain Functional Connectivity Adaptations Following Multiple-Modality Exercise and Mind-Motor Training in Older Adults at Risk of Dementia: An Exploratory Sub-Study. Front Aging Neurosci. 2020 Feb 25;12:22. doi: 10.3389/fnagi.2020.00022. eCollection 2020.
PMID: 32158386DERIVEDGregory MA, Gill DP, Shellington EM, Liu-Ambrose T, Shigematsu R, Zou G, Shoemaker K, Owen AM, Hachinski V, Stuckey M, Petrella RJ. Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol. BMC Geriatr. 2016 Jan 16;16:17. doi: 10.1186/s12877-016-0190-9.
PMID: 26772171DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Petrella, MD, PhD
The University of Western Ontario
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 13, 2014
Study Start
January 1, 2014
Primary Completion
September 1, 2015
Study Completion
March 1, 2016
Last Updated
September 7, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share