Cardiovascular DiseasesNCT05012878
Cardiac Rehab and Cerebral Blood Flow Study
A study testing Cardiac rehabilitation - high intensity interval training (HIIT), Cardiac rehabilitation - moderate intensity continuous training (MICT) and Cardiac rehabilitation - observational in people with Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to better understand the influence of cardiovascular disease on brain blood flow regulation and cognitive function, determine whether exercise-based cardiac rehabilitation can lead to better regulation of brain blood flow that may help to improve or maintain cognitive function, and determine… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiac rehabilitation - high intensity interval training (HIIT), Cardiac rehabilitation - moderate intensity continuous training (MICT) and Cardiac rehabilitation - observational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 23 Apr 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-years and older.
- Never been diagnosed with cardiovascular disease or coronary artery disease.
- No history of cardiovascular disease risk factors including hypertension, hyperlipidemia, diabetes, obesity (body mass index > 30) or smoking.
- Current body mass index < 30kg/m2
- Exclusion Criteria for participants in randomized cardiac rehabilitation groups (HIIT \& MICT) :
- Known cerebrovascular or neurological disease
Show all 22Show fewer
- Known moderate-severe respiratory disease, pregnancy,
- Orthopedic limitations affecting exercise capability
- Unable to read and speak English
- Unable to complete study-related activities
- Contraindications to hypercapnia
- Contraindications to maximal exercise testing
- MRI incompatible devices
- Unwillingness to undergo MRI scan (e.g. due to anxiety or claustrophobia).
- Exclusion Criteria for participants in the observational control group and observational cardiac rehabilitation group:
- Known cerebrovascular or neurological disease
- Known moderate-severe respiratory disease, pregnancy,
- Unable to read and speak English
- Unable to complete study-related activities
- Contraindications to hypercapnia
- MRI incompatible devices
- Unwillingness to undergo MRI scan (e.g. due to anxiety or claustrophobia)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Cerebral Blood Flow Regulation and Cognitive Function in Adults With Cardiovascular Disease - Influence of Exercise Training and Intensity
This study is being done to better understand the influence of cardiovascular disease on brain blood flow regulation and cognitive function, determine whether exercise-based cardiac rehabilitation can lead to better regulation of brain blood flow that may help to improve or maintain cognitive function, and determine whether exercise intensity influences changes in brain blood flow regulation and cognitive function.
Read the detailed description
This study will investigate the influence of exercise training and intensity (as part of cardiac rehabilitation) on improving cerebral blood flow regulation and cognitive function following a cardiac event. This will be a randomized control trial, recruiting adults in mid-life (years 40-65) with coronary artery disease, enrolling in cardiac rehabilitation following a cardiac-related hospital admission. Patients that enroll in the Mayo Clinic cardiac rehabilitation will be randomized 1:1 to high intensity interval training (HIIT) or moderate intensity continuous training (MICT), with stratification for sex and coronary artery bypass graft surgery. Patients that decline enrollment in cardiac rehabilitation will be recruited as an observational control group, which will be matched to the intervention groups by age decade, sex, BMI category, and surgical status. Patients that enroll in cardiac rehabilitation but decline randomization will be recruited as an observational cardiac rehabilitation group. A healthy control group without cardiovascular disease will also be recruited for baseline comparison of outcome measures.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiac rehabilitation - high intensity interval training (HIIT), Cardiac rehabilitation - moderate intensity continuous training (MICT), Cardiac rehabilitation - control, Cardiac rehabilitation - observational
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation - high intensity interval training (HIIT)Behavioural
Also called CR-HIIT
During cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 4x4-min high intensity aerobic intervals at a rating of perceived exertion 15-17 (hard to very hard), interspersed by a 3-min active recovery at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (4-min) and cool-down (3-min) at a light intensity.
Cardiac rehabilitation - moderate intensity continuous training (MICT)Behavioural
Also called CR-MICT
During cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 34-min of continuous aerobic exercise at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (3-min) and cool-down (3-min) at a light intensity.
Cardiac rehabilitation - controlBehavioural
Also called CR-Control
Participants will receive exercise advice in line with usual hospital discharge procedures. This involves exercise physiologists providing verbal and written information on achieving the national physical activity guidelines (150min/week of moderate intensity exercise) 60 and range of movement exercises for surgical patients with sternotomy. However, no structured or supervised exercise training program or other contact with participants will be provided after hospital discharge, to reflect the usual care process for patients that decline cardiac rehabilitation.
Cardiac rehabilitation - observationalBehavioural
Also called CR-Observational
During cardiac rehabilitation (12-weeks), program frequency and exercise training protocol will align with clinical care decisions and/or patient choice rather than random assignment.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation - High intensity interval training (HIIT) | Experimental | Patients attending cardiac rehabilitation randomized to HIIT. Receives: Behavioral: Cardiac rehabilitation - high intensity interval training (HIIT) |
| Cardiac rehabilitation - Moderate intensity continuous training (MICT) | Active comparator | Patients attending cardiac rehabilitation randomized to MICT. Receives: Behavioral: Cardiac rehabilitation - moderate intensity continuous training (MICT) |
| Cardiac rehabilitation - control | Placebo comparator | The control group (12 week period) will include participants who have declined cardiac rehabilitation. Receives: Behavioral: Cardiac rehabilitation - control |
| Healthy control group | No intervention | Healthy age-matched adults without cardiovascular disease, who will complete baseline assessments only. No intervention period. |
| Cardiac rehabilitation - observational | Other | This observational group will include patients who are completing an exercise-based cardiac rehabilitation program in line with standard care but are not part of the randomized exercise protocol groups (HIIT or MICT). Participants in this group will be combined with HIIT and MICT (as exercise-based cardiac rehabilitation group) for Aims 1b and 2b. Receives: Behavioral: Cardiac rehabilitation - observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow regulation (as cerebrovascular reactivity)
Measured as the change in cerebral blood flow during a stepped protocol of increases in inhaled carbon dioxide concentrations. Reactivity will be measured as the regression slope of cerebral blood flow velocity (cm per second) per mmHg increase in end-tidal carbon dioxide.
Measured: Baseline and follow-up at 3-months
Secondary outcomes (1)
Cognitive function
The main domains of cognitive function assessed using a neuropsychometric testing battery will be executive function, processing speed, and memory. Scores from these domains will be combined as the NIH Toolbox Fluid composite score, and assessed for change from baseline to follow-up. Analyses will also be completed for each separate cognitive domain.
Measured: Baseline and follow-up at 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start2 Sep 2021
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Model description
- Randomized control trial comparing two cardiac rehabilitation exercise groups: 1) high intensity interval training; and 2) moderate intensity continuous training. There will also be an observational control group who decline participation in cardiac rehabilitation, and an observational cardiac rehabilitation group who participate in cardiac rehabilitation but decline randomization. There is also a healthy control group without cardiovascular disease for baseline comparison only (no intervention).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Johnson, Mayo Clinic
- Investigators
- Bruce D Johnson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012878
- Sponsor's protocol ID
- 20-010808
- Status last verified
- May 2025
- First submitted
- 19 Jul 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow Regulation and Cognitive Function in Adults With Cardiovascular Disease - Influence of Exercise Training and Intensity
- ClinicalTrials.gov ID
- NCT05012878
- Acronym / sponsor ID
- 20-010808
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 19 Aug 2021 (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.
This study is being done to better understand the influence of cardiovascular disease on brain blood flow regulation and cognitive function, determine whether exercise-based cardiac rehabilitation can lead to better regulation of brain blood flow that may help to improve or maintain cognitive function, and determine whether exercise intensity influences changes in brain blood flow regulation and cognitive function.
Detailed description
This study will investigate the influence of exercise training and intensity (as part of cardiac rehabilitation) on improving cerebral blood flow regulation and cognitive function following a cardiac event. This will be a randomized control trial, recruiting adults in mid-life (years 40-65) with coronary artery disease, enrolling in cardiac rehabilitation following a cardiac-related hospital admission. Patients that enroll in the Mayo Clinic cardiac rehabilitation will be randomized 1:1 to high intensity interval training (HIIT) or moderate intensity continuous training (MICT), with stratification for sex and coronary artery bypass graft surgery. Patients that decline enrollment in cardiac rehabilitation will be recruited as an observational control group, which will be matched to the intervention groups by age decade, sex, BMI category, and surgical status. Patients that enroll in cardiac rehabilitation but decline randomization will be recruited as an observational cardiac rehabilitation group. A healthy control group without cardiovascular disease will also be recruited for baseline comparison of outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized control trial comparing two cardiac rehabilitation exercise groups: 1) high intensity interval training; and 2) moderate intensity continuous training. There will also be an observational control group who decline participation in cardiac rehabilitation, and an observational cardiac rehabilitation group who participate in cardiac rehabilitation but decline randomization. There is also a healthy control group without cardiovascular disease for baseline comparison only (no intervention).
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation - High intensity interval training (HIIT) | Experimental | Behavioral: Cardiac rehabilitation - high intensity interval training (HIIT)Patients attending cardiac rehabilitation randomized to HIIT. |
| Cardiac rehabilitation - Moderate intensity continuous training (MICT) | Active comparator | Behavioral: Cardiac rehabilitation - moderate intensity continuous training (MICT)Patients attending cardiac rehabilitation randomized to MICT. |
| Cardiac rehabilitation - control | Placebo comparator | Behavioral: Cardiac rehabilitation - controlThe control group (12 week period) will include participants who have declined cardiac rehabilitation. |
| Healthy control group | No intervention | –Healthy age-matched adults without cardiovascular disease, who will complete baseline assessments only. No intervention period. |
| Cardiac rehabilitation - observational | Other | Behavioral: Cardiac rehabilitation - observationalThis observational group will include patients who are completing an exercise-based cardiac rehabilitation program in line with standard care but are not part of the randomized exercise protocol groups (HIIT or MICT). Participants in this group will be combined with HIIT and MICT (as exercise-based cardiac rehabilitation group) for Aims 1b and 2b. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Aged 40-years and older.
- Never been diagnosed with cardiovascular disease or coronary artery disease.
- No history of cardiovascular disease risk factors including hypertension, hyperlipidemia, diabetes, obesity (body mass index > 30) or smoking.
- Current body mass index < 30kg/m2
- Exclusion Criteria for participants in randomized cardiac rehabilitation groups (HIIT \& MICT) :
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cardiac rehabilitation - high intensity interval training (HIIT)Also: CR-HIITDuring cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 4x4-min high intensity aerobic intervals at a rating of perceived exertion 15-17 (hard to very hard), interspersed by a 3-min active recovery at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (4-min) and cool-down (3-min) at a light intensity. | Behavioural | Cardiac rehabilitation - High intensity interval training (HIIT) |
| Cardiac rehabilitation - moderate intensity continuous training (MICT)Also: CR-MICTDuring cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 34-min of continuous aerobic exercise at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (3-min) and cool-down (3-min) at a light intensity. | Behavioural | Cardiac rehabilitation - Moderate intensity continuous training (MICT) |
| Cardiac rehabilitation - controlAlso: CR-ControlParticipants will receive exercise advice in line with usual hospital discharge procedures. This involves exercise physiologists providing verbal and written information on achieving the national physical activity guidelines (150min/week of moderate intensity exercise) 60 and range of movement exercises for surgical patients with sternotomy. However, no structured or supervised exercise training program or other contact with participants will be provided after hospital discharge, to reflect the usual care process for patients that decline cardiac rehabilitation. | Behavioural | Cardiac rehabilitation - control |
| Cardiac rehabilitation - observationalAlso: CR-ObservationalDuring cardiac rehabilitation (12-weeks), program frequency and exercise training protocol will align with clinical care decisions and/or patient choice rather than random assignment. | Behavioural | Cardiac rehabilitation - observational |
Primary outcome
Cerebral blood flow regulation (as cerebrovascular reactivity)
Time frame: Baseline and follow-up at 3-months
Measured as the change in cerebral blood flow during a stepped protocol of increases in inhaled carbon dioxide concentrations. Reactivity will be measured as the regression slope of cerebral blood flow velocity (cm per second) per mmHg increase in end-tidal carbon dioxide.
1 secondary outcome
Cognitive function
Time frame: Baseline and follow-up at 3-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 29 May 2025.
- 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.
Bruce D Johnson, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation - high intensity interval training (HIIT), Cardiac rehabilitation - moderate intensity continuous training (MICT) and Cardiac rehabilitation - observational in people with Cardiovascular Diseases, run by Mayo Clinic at 1 site in United States.
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 22 inclusion and 0 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 29 May 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Cerebral blood flow regulation (as cerebrovascular reactivity) (time frame: Baseline and follow-up at 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.