Clinical trial NCT03545958: The Heart & Mind Study
Official title: Exercise to Improve the Hearts and Minds of Canadian Older Adults With Hypertension: The Heart & Mind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cognitive Decline
Vascular Cognitive Impairment
Keywords: Older adults
Community-based
High-intensity interval training (HIT)
Mind-motor training
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 140
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Older adults with subjective cognitive decline (SCD) may represent a portion of the population experiencing early sings of cognitive decline. Systolic hypertension is a major contributor to cognitive impairment. High-intensity aerobic interval training (HIT) yields greater fitness and vascular health improvements compared to moderate-intensity aerobic continuous training (MCT). No randomized controlled trials, however, have investigated the effects HIT or MCT on cognition in older adults with hypertension and SCD. Much less is known regarding whether combining HIT or MCT with mind-motor training would culminate additive benefits to cognition. Therefore, the overarching goal of our research is to deliver a group-based exercise program combining mind-motor training with HIT or MCT to older adults with hypertension and SCD. Participants will be randomized into two groups. Participants in both groups will receive 15 minutes of square stepping exercise (SSE) followed by either 45 minutes of HIT (N=70) or 45 minutes of MCT (N=70). In total, both groups will exercise 60 min/day, 3 days/week for 6 months. The effects of both interventions will be evaluated on systolic and diastolic office/ambulatory blood pressure and global and domain-specific cognitive functioning.


Eligibility criteria: Inclusion Criteria:

* 55 years of age or older;
* Present with controlled or uncontrolled stage 1 hypertension (seated, resting clinic SBP 140 to 179 mmHg and/or DBP 90 to 109 mmHg) as per Hypertension Canada's 2017 Guidelines;
* Have preserved instrumental activities of daily living (scoring \>6/8 on the Lawton-Brody Instrumental Activities of Daily Living \[IADL\] scale);
* Present signs of SCD (defined as answering yes to the question: "Do you feel like your memory or thinking skills have gotten worse recently?");
* Report being concerned about SCD (defined as answering yes to the question: "If yes, are you concerned about the worsening of your memory or thinking skills?");
* Preserved objective cognitive performance (i.e., no signs of MCI or dementia) defined by scoring ≥ 26 on the Montreal Cognitive Assessment (MoCA);
* Must be able to provide written informed consent.

Exclusion Criteria:

* Present signs of objective cognitive impairment (i.e., signs of MCI or dementia), defined by scoring ≤ 25 on the MoCA combined with study physician consult;
* Present resting stage 2 hypertension (seated, resting clinic SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
* Present significant neurological conditions or psychiatric disorders (e.g., Parkinson's disease or stroke \<1 year); 4) present history of severe cardiovascular conditions (e.g., recent \[\<1 year\] myocardial infarction, left ventricular hypertrophy) and symptomatic cerebrovascular disease;
* Present significant orthopaedic conditions (e.g., severe osteoarthritis in the lower limbs);
* Present untreated clinical depression (i.e., score \>15 on the Center for Epidemiologic Studies - Depression scale combined with study physician consult);
* Unable to comprehend the study letter of information. Participants will also be excluded for any other factors that could potentially limit their ability to fully participate in the study.

Primary outcomes:
measure: Composite score from Cambridge Brain Sciences Cognitive Battery
timeFrame: Change from 0 to 6 months
measure: Automated office Systolic Blood Pressure
timeFrame: Change from 0 to 6 months
Secondary outcomes:
measure: 24-hour Blood Pressure monitoring
timeFrame: Change from 0 to 6 months
measure: Maximal oxygen uptake (VO2max)
timeFrame: Change from 0 to 6 months
measure: Trail-Making Test
timeFrame: Change from 0 to 6 months
measure: Memory
timeFrame: 0 to 6 months
measure: Reasoning
timeFrame: 0 to 6 months
measure: Planning
timeFrame: 0 to 6 months
measure: Concentration
timeFrame: 0 to 6 months
Other outcomes:
measure: Dual-Task Gait Velocity
timeFrame: 0 to 6 months
measure: Dual-Task Gait Step Length
timeFrame: 0 to 6 months
measure: Dual-Task Gait Variability
timeFrame: 0 to 6 months
Locations:
city: London
country: Canada
facility: Western University, Western Centre for Public Health and Family Medicine
state: Ontario
Study officials:
affiliation: Study Principal Investigator
name: Robert Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boa Sorte Silva NC, Petrella AFM, Christopher N, Marriott CFS, Gill DP, Owen AM, Petrella RJ. The Benefits of High-Intensity Interval Training on Cognition and Blood Pressure in Older Adults With Hypertension and Subjective Cognitive Decline: Results From the Heart & Mind Study. Front Aging Neurosci. 2021 Apr 15;13:643809. doi: 10.3389/fnagi.2021.643809. eCollection 2021.