NCT02136368

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

April 29, 2014

Last Update Submit

September 6, 2016

Conditions

Keywords

older adultsmultiple-modality exercisemind-motor exerciseself-reported cognitive complaintsglobal cognitive functioningmobilityvascular functionsensorimotor functionbrain imagingcommunity-based researchsubjective cognitive complaints

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)

EXPERIMENTAL

Attend 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.

Behavioral: Multi-modal exerciseBehavioral: Mind-Motor Exercise

Multi-Modal Exercise (M2)

ACTIVE COMPARATOR

Attend 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.

Behavioral: Multi-modal exerciseBehavioral: 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)

Also known as: Exercise intervention
Multi-Modal Exercise (M2)Multi-Modal, Mind Motor Exercise (M4)

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).

Also known as: Square Stepping Exercise
Multi-Modal, Mind Motor Exercise (M4)

Community-based group exercise designed to improve balance and range of motion of the joints (15 min)

Multi-Modal Exercise (M2)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • Gregory 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.

MeSH Terms

Interventions

Range of Motion, Articular

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert J Petrella, MD, PhD

    The University of Western Ontario

    PRINCIPAL INVESTIGATOR

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

Locations