HypertensionNCT03545958
The Heart & Mind Study
A study testing High-intensity Interval Training (HIT) and Moderate-intensity Continuous Training (MCT) in people with Hypertension and Cognitive Decline, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension, Cognitive Decline, Vascular Cognitive Impairment
- What is being tested?
- High-intensity Interval Training (HIT) and Moderate-intensity Continuous Training (MCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2018to 21 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Western University, Western Centre for Public Health and Family Medicine
London, Ontario, N6G 2M1
About this study
Official title: Exercise to Improve the Hearts and Minds of Canadian Older Adults With Hypertension: The Heart & Mind Study
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.
- Being tested
- High-intensity Interval Training (HIT), Moderate-intensity Continuous Training (MCT)
- Keywords
- Older adults, Community-based, High-intensity interval training (HIT), Mind-motor training
- Medical subject headings
- Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity Interval Training (HIT)Behavioural
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.
Moderate-intensity Continuous Training (MCT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity Interval Training (HIT) | Experimental | 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. Receives: Behavioral: High-intensity Interval Training (HIT) |
| Moderate-intensity Continuous Training (MCT) | Active comparator | 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. Receives: Behavioral: Moderate-intensity Continuous Training (MCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score from Cambridge Brain Sciences Cognitive Battery
Global cognitive functioning assessment
Measured: Change from 0 to 6 months
Automated office Systolic Blood Pressure
Resting blood pressure
Measured: Change from 0 to 6 months
Secondary outcomes (7)
24-hour Blood Pressure monitoring
Ambulatory blood pressure assessment
Measured: Change from 0 to 6 months
Maximal oxygen uptake (VO2max)
Cardiorespiratory fitness assessment
Measured: Change from 0 to 6 months
Trail-Making Test
Executive Functioning assessment
Measured: Change from 0 to 6 months
Memory
Composite measure derived from the Cambridge Brain Sciences cognitive battery (Hampshire, Highfield, Parkin, \& Owen, 2012). The composite score is derived from 4 cognitive tasks: Monkey Ladder (visuospatial working memory), Spatial Span (short-term memory), Digit Span (verbal working memory), and Paired Associates (visuospatial learning). For each of the cognitive tasks, higher scores indicate better outcomes. The scores from each task are standardized and averaged to generate a standardized composite measure of memory, i.e., z scores with a mean of 0 and a standard deviation of 1. The standardized scores can range from negative infinity to positive infinity.
Measured: 0 to 6 months
Reasoning
Composite measure from the Cambridge Brain Sciences cognitive battery. The composite score is derived from 3 cognitive tasks: Grammatical Reasoning (verbal reasoning), Double Trouble (modified Stroop task), and Odd One Out (deductive reasoning). For each of the cognitive tasks, higher scores indicate better outcomes. The scores from each task are standardized and averaged to generate a standardized composite measure of reasoning, i.e., z scores with a mean of 0 and a standard deviation of 1. The standardized scores can range from negative infinity to positive infinity.
Measured: 0 to 6 months
Planning
Composite measure from the Cambridge Brain Sciences cognitive battery. The composite score is derived from 2 cognitive tasks: Spatial Planning (planning and executive function) and Token Search (working memory and strategy). For each of the cognitive tasks, higher scores indicate better outcomes. The scores from each task are standardized and averaged to generate a standardized composite measure, i.e., z scores with a mean of 0 and a standard deviation of 1. The standardized scores can range from negative infinity to positive infinity.
Measured: 0 to 6 months
Concentration
Composite measure from the Cambridge Brain Sciences cognitive battery. The composite score is derived from 3 cognitive tasks: Rotations (mental rotation), Feature Match (feature-based attention and concentration), and Polygons (visuospatial processing). For each of the cognitive tasks, higher scores indicate better outcomes. The scores from each task are standardized and averaged to generate a standardized composite measure, i.e., z scores with a mean of 0 and a standard deviation of 1. The standardized scores can range from negative infinity to positive infinity.
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start15 Nov 2018
- Primary completion21 Mar 2020
- Study completion21 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Petrella, Western University, Canada
- Investigators
- Robert Petrella, MD, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545958
- Sponsor's protocol ID
- 111686
- Status last verified
- Aug 2020
- First submitted
- 22 May 2018
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33935686
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise to Improve the Hearts and Minds of Canadian Older Adults With Hypertension: The Heart & Mind Study
- ClinicalTrials.gov ID
- NCT03545958
- Acronym / sponsor ID
- 111686
- Keywords
- Older adults, Community-based, High-intensity interval training (HIT), Mind-motor training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity Interval Training (HIT) | Experimental | Behavioral: 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. |
| Moderate-intensity Continuous Training (MCT) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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?");
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | High-intensity Interval Training (HIT) |
| 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. | Behavioural | Moderate-intensity Continuous Training (MCT) |
Primary outcome
Composite score from Cambridge Brain Sciences Cognitive Battery
Time frame: Change from 0 to 6 months
Global cognitive functioning assessment
Automated office Systolic Blood Pressure
Time frame: Change from 0 to 6 months
Resting blood pressure
7 secondary outcomes
24-hour Blood Pressure monitoring
Time frame: Change from 0 to 6 months
Maximal oxygen uptake (VO2max)
Time frame: Change from 0 to 6 months
Trail-Making Test
Time frame: Change from 0 to 6 months
Memory
Time frame: 0 to 6 months
Reasoning
Time frame: 0 to 6 months
Planning
Time frame: 0 to 6 months
Concentration
Time frame: 0 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 33935686Boa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Petrella, MD, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity Interval Training (HIT) and Moderate-intensity Continuous Training (MCT) in people with Hypertension and Cognitive Decline, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score from Cambridge Brain Sciences Cognitive Battery (time frame: Change from 0 to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.