Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

University of British Columbia

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Balance and Tone Training; Behavioral: Aerobic Training; Behavioral: Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02737878

H15-02181

Details and patient eligibility

About

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.

Full description

Investigators will conduct a 6-month assessor-blinded randomized-controlled trial of 216 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). A 12-month followup (i.e., 18 months from baseline) measurement will also be done.

Enrollment: 226 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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 = or > 22 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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226 participants in 4 patient groups

Aerobic Training and Resistance Training (AT&RT)

Experimental group

Description:

The AT\&RT program will be a four-times-per week program. Twice a week will be aerobic training (AT) with a series of standardized AT exercise stations. Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days a week will be resistance training (RT) in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 repetition maximum (1RM) as determined at week 6 using an 8-repetition maximum (8RM) test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.

Treatment:

Behavioral: Resistance Training

Behavioral: Aerobic Training

Aerobic Training (AT)

Experimental group

Description:

The AT program will be a four-times-per week program. Twice a week will be AT with a series of standardized AT exercise stations (e.g., treadmills, stationary cycles, aerobic steppers, agility ladders). Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days per week will be a balance and tone (CON) program consisting of stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.

Treatment:

Behavioral: Balance and Tone Training

Behavioral: Balance and Tone Training

Behavioral: Aerobic Training

Resistance Training (RT)

Experimental group

Description:

The RT program will be a four-times-per week program. Twice a week will be RT in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 RM as determined at week 6 using an 8RM test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.The other two days per week will be a CON program consisting of stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.

Treatment:

Behavioral: Resistance Training

Behavioral: Balance and Tone Training

Behavioral: Balance and Tone Training

Balance and Tone Program (CON)

Active Comparator group

Description:

The CON program will be a four-times-per week program. The CON group will consiste of stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.

Treatment:

Behavioral: Balance and Tone Training

Behavioral: Balance and Tone Training