Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

Mild Cognitive Impairment Clinical Trial

Official title:

Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription: Understanding Training Type and Exploring Mechanisms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02737878
• Other study ID #: H15-02181
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 13, 2017
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 be done for a sub-set of participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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). 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 compliance.
• 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). 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 compliance.
• 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. 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 compliance.
• 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. 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 compliance.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)	Cognition	Baseline to 6 months
Secondary	Executive functions as measured by standard neuropsychological and computerized tests	Executive functions	Baseline and 6 months and 18 months
Secondary	Cardiometabolic risk factors as measured by blood panel	Cardiometabolic risk factors	Baseline and 6 months
Secondary	Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)	Quality of life	Baseline, 3 months, 6 months, 12 months, and 18 months
Secondary	Health related quality of life as measured by the ICE-CAP	Quality of life	Baseline, 3 months, 6 months, 12 months, and 18 months
Secondary	Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)	Depressive symptoms	Baseline and 6 months
Secondary	Brain function as measured by functional magnetic resonance imaging (fMRI)	Brain function	Baseline and 6 months
Secondary	Brain structure as measured by structural magnetic resonance imaging	Brain structure	Baseline and 6 months
Secondary	White matter lesion volume as measured by magnetic resonance imaging	White matter lesion	Baseline and 6 months
Secondary	Diffusion tensor imaging as measured by magnetic resonance imaging	White matter integrity	Baseline and 6 months
Secondary	Memory as measured by standard neuropsychological and computerized tests	Memory	Baseline and 6 months and 18 months
Secondary	Visualspatial ability as measured by standard neuropsychological and computerized tests	Visualspatial ability	Baseline and 6 months
Secondary	Cardiorespiratory capacity as measured by treadmill test	Cardiovascular fitness	Baseline and 6 months
Secondary	Mobility as measured by 400-m walk	Mobility	Baseline and 6 months and 18 months
Secondary	Cardiometabolic risk as measured by waist to hip ratio	Cardiometabolic risk	Baseline and 6 months and 18 months
Secondary	Cardiometabolic risk as measured by body mass index	Cardiometabolic risk	Baseline and 6 months and 18 months.
Secondary	Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness)	Cardiometabolic risk	Baseline and 6 months
Secondary	Cortisol levels through saliva samples (subset)	Cortisol levels	5 times from baseline to 6 months
Secondary	Lower body strength as measured by the 30 sec sit-to-stand (subset)	Lower body strength	Baseline and 6 months and 18 months
Secondary	Lower body strength as measured by Biodex	Lower body strength	Baseline and 6 months
Secondary	Upper body strength as measured by grip strength	Upper body strength	Baseline and 6 months
Secondary	Sleep quality as measured by Motion Watch actigraphy	Sleep quality	Baseline and 6 months
Secondary	Neurotrophic factors as measured by blood	Neurotrophic factors	Baseline and 6 months
Secondary	Mobility as measured by Short Physical Performance Battery	Mobility	Baseline and 6 months and 18 months
Secondary	Community mobility as measured by the Life Space Questionnaire	Mobility	Baseline, 3 months, 6 months, 12 months, and 18 months
Secondary	Body composition as measured by DXA	Body composition	Baseline and 6 months
Secondary	Loneliness as measured by the UCLA Loneliness Scale	Loneliness	Baseline and 6 months
Secondary	Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items	Cognitive function	Baseline and 6 months and 18 months
Secondary	Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire	Sedentary behaviour	Baseline, 3 months, 6 months, 12 months, and 18 months
Secondary	Risk of sleep apnea as measured by the STOP Bang Questionnaire	Sleep apnea risk	Baseline and 6 months
Secondary	Prospective falls via Monthly Calendars	Accidental falls	Baseline and 3 months and 6 months and monthly
Secondary	Social support as measured by Social Provision Scale	Social support	Baseline and 6 months
Secondary	Mindfulness as measured by the Mindfulness Attention Awareness Scale	Mindfulness	Baseline and 6 months
Secondary	Memory as measured by the Everyday Memory Questionnaire	Memory	Baseline and 6 months
Secondary	Sleep as measured by the Pittsburgh Sleep Quality Index	Sleep	Baseline, 6 months, 12 months, and 18 months
Secondary	Functional ability as measured by the Lawson IADL	Instrumental activities of daily living	Baseline and 6 months
Secondary	Comorbidities as measured by the Function Comorbidity Index	Chronic conditions	Baseline, 6 months, 12 months, and 18 months
Secondary	Mood as measured by the State and Trait Anxiety Inventory	Mood	Baseline and 6 months and 18 months
Secondary	Social network as measured by Lubben Social Network Scale	Social network	Baseline and 6 months
Secondary	Physical activity as measured by the CHAMP Questionnaire	Physical Activity Level	Baseline and 3 months and 6 months and monthly
Secondary	ADAS-Cog Plus	Cognitive function	18 months
Secondary	Verbal memory and learning using the Rey Auditory Verbal Learning Test	Verbal memory and learning	Baseline, 6 months, and 18 months
Secondary	Verbal fluency (categorial of animals and semantic using F,A,S)	Verbal functioning tests requiring retrieval	Baseline, 6 months, and 18 months
Secondary	Cytokines - proteins involved in immune response, as measured by blood	Cytokines	Baseline and 6 months
Secondary	Dual-task gait using Gaitrite	Dual-task walking	Baseline and 6 months
Secondary	Health resource utilization (e.g., access health system services/resources)	Access health system services/resources	Baseline, 3 months, and 6 months
Secondary	Physical activity level (i.e., amount of light, moderate, and vigorous) measured by Motion Watch actigraphy	Physical activity levels	Baseline and 6 months
Secondary	Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy	Sedentary behaviour	Baseline and 6 months
Secondary	Quality of life measured by EQ-5D-5L	Quality of life	Baseline, 3 months, 6 months, and 18 months
Secondary	Wellbeing measured by ICE-CAP	Wellbeing	Baseline, 3 months, 6 months, and 18 months
Secondary	Telemere length	Marker of aging	Baseline and 6 months