Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

NCT02737878 | Completed DMC

• 1 other identifier: H15-02181
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)

  Cognition

  Baseline to 6 months

Secondary Outcomes (55)

• Executive functions as measured by standard neuropsychological and computerized tests

  Baseline and 6 months and 18 months

• Intraindividual variability (IIV) in executive functions as measured by the NIH ToolBox Cognitive Battery

  Baseline and 6 months and 18 months

• Cardiometabolic risk factors as measured by blood panel

  Baseline and 6 months

• Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)

  Baseline, 3 months, 6 months, 12 months, and 18 months

• Health related quality of life as measured by the ICE-CAP

  Baseline, 3 months, 6 months, 12 months, and 18 months

Study Arms (4)

Aerobic Training and Resistance Training (AT&RT)

EXPERIMENTAL

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.

Behavioral: Aerobic Training; Behavioral: Resistance Training

Aerobic Training (AT)

EXPERIMENTAL

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.

Behavioral: Aerobic Training; Behavioral: Balance and Tone Training

Resistance Training (RT)

EXPERIMENTAL

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.

Behavioral: Resistance Training; Behavioral: Balance and Tone Training

Balance and Tone Program (CON)

ACTIVE COMPARATOR

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.

Behavioral: Balance and Tone Training

Interventions

Aerobic Training BEHAVIORAL

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). To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of wearables to monitor heart rate. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Aerobic Training (AT); Aerobic Training and Resistance Training (AT&RT)

Resistance Training BEHAVIORAL

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). To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of a set of resistance bands of various weights. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Aerobic Training and Resistance Training (AT&RT); Resistance Training (RT)

Balance and Tone Training BEHAVIORAL

Six months of twice-weekly stretching and relaxation program that includes 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. Each session will be 60 minutes. To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of small equipment (e.g., pilate ball). Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Aerobic Training (AT); Balance and Tone Program (CON); Resistance Training (RT)

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (2)

• Balbim GM, Boa Sorte Silva NC, Falck RS, Kramer AF, Voss MW, Liu-Ambrose T. 24-hour activity cycle behaviors and gray matter volume in mild cognitive impairment. Alzheimers Dement. 2025 Jul;21(7):e70496. doi: 10.1002/alz.70496.

  PMID: 40693459 DERIVED

• Barha CK, Falck RS, Best JR, Nagamatsu LS, Hsiung GR, Sheel AW, Hsu CL, Kramer AF, Voss MW, Erickson KI, Davis JC, Shoemaker JK, Boyd L, Crockett RA, Ten Brinke L, Bherer L, Singer J, Galea LAM, Jacova C, Bullock A, Grant S, Liu-Ambrose T. Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. Trials. 2022 Sep 9;23(1):766. doi: 10.1186/s13063-022-06699-7.

  PMID: 36085237 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Cindy Barha, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Joel Singer, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: November 13, 2017
• Primary Completion: August 22, 2024
• Study Completion: August 26, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)