NCT01572311

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

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

First Submitted

Initial submission to the registry

April 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

April 3, 2012

Last Update Submit

October 24, 2014

Conditions

Keywords

Aerobic exerciseCognitionDual TaskGait TrainingGroup-based exerciseOlder adults

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (21)

  • Global cognitive functioning

    12 & 52 weeks

  • Executive Function/Mental Flexibility

    12, 26, and 52 weeks

  • Processing Speed

    12, 26 and 52 weeks

  • Verbal Learning and Memory

    12, 26 and 52 weeks

  • Verbal Fluency

    12, 26 and 52 weeks

  • +16 more secondary outcomes

Study Arms (2)

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)

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

Behavioral: Exercise Control

Interventions

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.

Also known as: Aerobic exercise and dual-task training
Exercise Intervention Group

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.

Also known as: Aerobic exercise and gait training
Exercise Control group

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aging, Rehabilitation and Geriatric Care Research Center

London, Ontario, N6C 5J1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert J Petrella, MD., PhD.

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    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 3, 2012

First Posted

April 6, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

May 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations