Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737878
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Teresa Liu-Ambrose, University of British Columbia

Brief Summary:
Dementia is one of the most pressing health care issues of the 21st century. Evidence suggests that exercise enhances cognitive function in healthy older adults. Most research has focused on aerobic training (AT). Therefore, investigators aim to assess the individual effects of AT and resistance training (RT), as well as the interaction effect of combining the two types of exercise training, on cognitive function in older adults with mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Aerobic Training Behavioral: Resistance Training Behavioral: Balance and Tone Training Behavioral: Balance and Tone Program Not Applicable

Detailed Description:
Investigators will conduct a 6-month assessor-blinded randomized-controlled trial of 200 community-dwelling adults with mild cognitive impairment. Individuals will be randomized to one of four experimental groups, all which receive 6 months of exercise classes four times per week: 1) combined aerobic training and resistance training; 2) aerobic training; 3) resistance training; or 4) balance and toning exercise. There will be two measurement sessions: baseline and 6 months (end of intervention period).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription: Understanding Training Type and Exploring Mechanisms
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Training and Resistance Training (A&RT)
The A&RT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form.
Behavioral: Aerobic Training
Six months of twice-weekly aerobic training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Behavioral: Resistance Training
Six months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Experimental: Aerobic Training (AT)
The AT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.
Behavioral: Aerobic Training
Six months of twice-weekly aerobic training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Behavioral: Balance and Tone Training
Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.

Experimental: Resistance Training (RT)
The RT program will be a four-times-per week program. Twice a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.
Behavioral: Resistance Training
Six months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Behavioral: Balance and Tone Training
Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.

Active Comparator: Balance and Tone Program (CON)
The CON program will be a four-times-per week program. The CON group will consist of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.
Behavioral: Balance and Tone Program
Six months of four times a week stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.




Primary Outcome Measures :
  1. Change in cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Executive functions as measured by standard neuropsychological tests [ Time Frame: Baseline and 6 months ]
  2. Changes in cardiometabolic risk factors as measured by blood panel [ Time Frame: Baseline and 6 months ]
  3. Changes in health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: Baseline and 6 months ]
  4. Mood as measured by the Geriatric Depression Scale Shortened Version (GDS) [ Time Frame: baseline and 6 months ]
  5. Changes in brain structure as measured by functional magnetic resonance imaging (fMRI) [ Time Frame: baseline and 6 months ]
  6. Memory as measured by standard neuropsychological tests [ Time Frame: Baseline and 6 months ]
  7. Functional Capacity as measured by 6 minute walk test [ Time Frame: Baseline and 6 months ]
  8. Cardiometabolic risk factors as measured by waist to hip ratio [ Time Frame: Baseline and 6 months ]
  9. Cardiometabolic risk factors as measured by body mass index [ Time Frame: Baseline and 6 months ]
  10. Cortisol levels through saliva samples [ Time Frame: 5 times from baseline to 6 months ]
  11. Changes in lower body strength as measured by the 30 sec sit-to-stand [ Time Frame: Baseline and 6 months ]
  12. Change in upper body strength as measured by grip strength [ Time Frame: Baseline and 6 months ]
  13. Sleep monitoring as measured by Motion Watch actigraphy [ Time Frame: Baseline, 3 months, and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Community-dwelling in Metro Vancouver
  • Have subjective memory complaints, defined as the self-reported feeling of memory worsening with an onset within the last 5 years, as determined by interview and corroborated by an informant
  • Have a baseline Montreal Cognitive Assessment (MoCA) score < 26/30
  • Mini-Mental State Examination (MMSE) score > 24 at screening
  • Read, write, and speak English
  • Not expected to start or are stable on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine, etc.) during the 6-month intervention period
  • Able to walk independently
  • Must be in sufficient health to participate in the exercise programs
  • Able to comply with scheduled visits, treatment plan, and other trial procedures
  • Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals

Exclusion Criteria:

  • Engaged in moderate (e.g., brisk walking) physical activity > 1 time per week, or > 60 minutes per week, in the 3 months prior to study entry
  • Diagnosed with dementia of any type
  • Clinically suspected to have neurodegenerative disease as the cause of mild cognitive impairment (MCI) that is not Alzheimer's Disease (AD), vascular cognitive impairment (VCI), or both (e.g., multiple sclerosis, Parkinson's disease, Huntington's disease, frontotemporal dementia)
  • At high risk for cardiac complications during exercise or unable to self-regulate activity or to understand recommended activity level; 5) have clinically important peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician
  • Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid)
  • On any hormone therapy (estrogen, progesterone, or testosterone) in the last 24 months
  • Planning to participate, or already enrolled in, a concurrent clinical drug or exercise trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737878


Contacts
Layout table for location contacts
Contact: Michelle Munkacsy, MHK 604-875-4111 ext 69056 michelle.munkacsy@hiphealth.ca

Locations
Layout table for location information
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Michelle Munkacsy, MHK    604-875-4111 ext 69056    michelle.munkacsy@hiphealth.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Layout table for investigator information
Principal Investigator: Teresa Liu-Ambrose, PhD, PT University of British Columbia
Principal Investigator: John Best, PhD University of British Columbia
Principal Investigator: Jennifer Davis, PhD University of British Columbia
Principal Investigator: Lara Boyd, PhD University of British Columbia
Principal Investigator: Liisa Galea, PhD University of British Columbia
Principal Investigator: Charlie Goldsmith, PhD Simon Fraser University
Principal Investigator: Ging-Yuek Robin Hsiung, MD, PhD University of British Columbia
Principal Investigator: Alexander MacKay, PhD University of British Columbia
Principal Investigator: Lindsay Nagamatsu, PhD Western University
Principal Investigator: Claudia Jacova, PhD Pacific University
Principal Investigator: Arthur Kramer, PhD Northeastern University
Principal Investigator: Michelle Voss, PhD University of Iowa

Layout table for additonal information
Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02737878    
Other Study ID Numbers: H15-02181
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders