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The Heart & Mind Study

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ClinicalTrials.gov Identifier: NCT03545958
Recruitment Status : Not yet recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Petrella, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Hypertension Cognitive Decline Vascular Cognitive Impairment Behavioral: High-intensity Interval Training (HIT) Behavioral: Moderate-intensity Continuous Training (MCT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The Research Coordinator will manage recruitment and enrolment of study participants, and will not be involved in either measurement or the intervention. Research personnel performing the outcome assessments and data analysis will be blinded to group allocation but it is not possible to blind participants and personnel delivering the interventions.
Primary Purpose: Prevention
Official Title: Exercise to Improve the Hearts and Minds of Canadian Older Adults With Hypertension: The Heart & Mind Study
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-intensity Interval Training (HIT)
Participants in this groups will receive 15 minutes in the mind-motor training (i.e., Square-Stepping Exercise) followed by a 45-minute HIT intervention.
Behavioral: High-intensity Interval Training (HIT)
Following the mind-motor training component, participants in the experimental group will then continue in the 45-minute HIT intervention, which will be composed by a 10-minute warm-up, a 25-minute core activity, and a 10-minute cool down. The 25-minute core activity will be carried out based on a 4 x 4 minutes aerobic interval training model. The intensity in each cycle will be prescribed at an individual level, and training heart rates will be determined via a sub-maximal excise testing at baseline and monitored during exercise using a wrist-based heart rate monitor (Suunto). In order to ensure progression in aerobic training over the 6-month intervention, training heart rates will be recalculated at the intervention midpoint (i.e., 3 months), where a new sub-maximal exercise test will be performed. Participants will exercise 60 minutes/day, 3 days/week for 6 months.

Active Comparator: Moderate-intensity Continuous Training (MCT)
Participants in this groups will receive 15 minutes in the mind-motor training (i.e., Square-Stepping Exercise) followed by a 45-min MCT intervention.
Behavioral: Moderate-intensity Continuous Training (MCT)
After the mind-motor training component, participants in the comparison/control group will then continue in the 45-min MCT intervention, which will be composed by a 10-minute warm-up a 25-minute moderate-intensity continuous aerobic exercise training, and a 10-minute cool down. The exercise intensity will be prescribed at an individual level, and training heart rates will be determined via a sub-maximal excise testing at baseline and monitored during exercise using a wrist-based heart rate monitor (Suunto). In order to ensure progression in aerobic training over the 6-month intervention, training heart rates will be recalculated at the intervention midpoint (i.e., 3 months), where a new sub-maximal exercise test will be performed. Participants will exercise 60 minutes/day, 3 days/week for 6 months.




Primary Outcome Measures :
  1. Composite score from Cambridge Brain Sciences Cognitive Battery [ Time Frame: Change from 0 to 6 months ]
    Global cognitive functioning assessment

  2. Automated office Systolic Blood Pressure [ Time Frame: Change from 0 to 6 months ]
    Resting blood pressure


Secondary Outcome Measures :
  1. 24-hour Blood Pressure monitoring [ Time Frame: Change from 0 to 6 months ]
    Ambulatory blood pressure assessment

  2. Maximal oxygen uptake (VO2max) [ Time Frame: Change from 0 to 6 months ]
    Cardiorespiratory fitness assessment

  3. Trail-Making Test [ Time Frame: Change from 0 to 6 months ]
    Executive Functioning assessment

  4. Memory [ Time Frame: 0 to 6 months ]
    Composite measure from the Cambridge Brain Sciences

  5. Reasoning [ Time Frame: 0 to 6 months ]
    Composite measure from the Cambridge Brain Sciences

  6. Planning [ Time Frame: 0 to 6 months ]
    Composite measure from the Cambridge Brain Sciences

  7. Concentration [ Time Frame: 0 to 6 months ]
    Composite measure from the Cambridge Brain Sciences



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) 55 years of age or older; 2) present with controlled or uncontrolled stage 1 hypertension (seated, resting clinic systolic blood pressure (SBP) 140 to 179 mmHg and/or diastolic blood pressure (DBP) 90 to 109 mmHg) as per Hypertension Canada's 2017 Guidelines; 3) have preserved instrumental activities of daily living (scoring >6/8 on the Lawton-Brody Instrumental Activities of Daily Living scale); 4) present signs of subjective cognitive decline (SCD) (defined as answering yes to the question: "Do you feel like your memory or thinking skills have gotten worse recently?"); 5) 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?"); 6) preserved objective cognitive performance, i.e., scoring ≥ 27 on the Montreal Cognitive Assessment (MoCA).

Exclusion Criteria:

1) present signs of objective cognitive impairment, i.e., defined by scoring ≤ 26 on the MoCA; 2) present resting stage 2 hypertension (seated, resting clinic SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg); 3) 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; 5) present significant orthopaedic conditions (e.g., severe osteoarthritis in the lower limbs); 6) present clinical depression (i.e., score >15 on the Centers for Epidemiologic Studies - Depression scale combined with study physician consult); 7) or are unable to comprehend the study letter of information and provide written informed consent. Participants will also be excluded for any other factors that could potentially limit their ability to fully participate in the study.


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): NCT03545958


Contacts
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Contact: Narlon Silva, BSc 519-661-2111 ext 22119 nboasort@uwo.ca
Contact: Dawn Gill, PhD 519-661-2111 ext 20658 dawn.gill@uwo.ca

Locations
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Canada, Ontario
Western Centre for Public Health and Family Medicine Not yet recruiting
London, Ontario, Canada, N6G 2M1
Contact: Dawn Gill, PhD    5196612111 ext 20658    dawn.gill@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Robert Petrella, MD, PhD Study Principal Investigator

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Responsible Party: Robert Petrella, Associate Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03545958     History of Changes
Other Study ID Numbers: 111686
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Petrella, Western University, Canada:
Older adults
Community-based
High-intensity interval training (HIT)
Mind-motor training

Additional relevant MeSH terms:
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Hypertension
Cognitive Dysfunction
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders