StrokeNCT05612776
HIIT vs HRV-based Training for Rehabilitation After Stroke
A study testing HIIT and HRV in people with Stroke and Cardiac Disease, run by Universidad de Almeria at 1 site in Spain.
Trial summary
Consequences of stroke are manyfold but all of them are important factors on the long-term outcomes of rehabilitation, becoming an important health problem with requires health strategies with advanced age. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Cardiac Disease, Ischemic Stroke
- What is being tested?
- HIIT and HRV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 1 Dec 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- left ejection fraction higher than 30% after stroke
- aged between 18 and 80 years old
Who cannot join
- presence of absolute or relative contraindications for accomplishing the treadmill test, indicated by the Spanish Society of Cardiology
- being treated for other diseases, or regularly taking a drug(s) that has a direct or indirect effect on the nervous system (e.g., anxiolytics, antidepressants or neuroleptics)
- absence of medication to control the cardiovascular disease or its modification during the intervention
- people who are participating or have participated in the previous three months in other similar exercise programs
- not performing at least 80% of the workouts during the intervention
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CITE III
Almería, 04120
María Carrasco, PhD, 950214773 ext. 84773, carrasco@ual.es
About this study
Official title: High Intensity Interval Training (HIIT) vs Heart Rate Variability (HRV) Training for Cardiac and Functional Rehabilitation After Stroke
Consequences of stroke are manyfold but all of them are important factors on the long-term outcomes of rehabilitation, becoming an important health problem with requires health strategies with advanced age. High intensity interval training (HIIT) is an efficient training protocol used in cardiac rehabilitation programs, but owing to the inter-individual variability in physiological responses to training associated to cardiovascular diseases, the exercise dose received by each patient should be closely controlled and individualized to ensure the safety and efficiency of the exercise program. The heart rate variability (HRV) is actually being used for this purpose, as it is closely linked to de parasympathetic nervous system activation. In this way, higher scores in HRV are associated with a good cardiovascular adaptation. The objective of this protocol is to determine the effect of HIIT compared with HRV-guided training on cardiorespiratory fitness, heart rate variability, functional parameters, body composition, quality of life, inflammatory markers, cognitive function, and feasibility, safety and adherence in patients after stroke undertaking an 8-week cardiac rehabilitation program. This will be a cluster-randomized controlled protocol in which patients after stroke will be assigned to an HRV-based training group (HRV-G) or a HIIT-based training group (HIIT-G). HIIT-G will train according to a predefined training program. HRV-G training will depend on the patients' daily HRV. The peak oxygen uptake (VO2peak), endothelial and work parameters, the heart rate variability, the functional parameters, the relative weight and body fat distribution, the quality of life, the inflammatory markers, the cognitive function, and the exercise adherence, feasibility and safety will be considered as the outcomes. It is expected that this HRV-guided training protocol will improve functional performance in the patients after stroke, being more safe, feasible and generating more adherence than HIIT, providing a better strategy to optimize the cardiac rehabilitation interventions.
- Being tested
- HIIT, HRV
- Keywords
- Heart Rate Variability, HIIT, cardiac rehabilitation, safety, adherence, VO2peak
- Medical subject headings
- Stroke, Heart Diseases, Ischemic Stroke, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
HIIT training will consist of performing high intensity intervals along with passive rests. The intensity of the exercise will be progressively increased and the rest time will be decreased. All participants will perform the same training according to the maximum heart rate reached in the Bruce test.
HRVOther
The intervention group will perform HRV-based training, measuring HRV every day before training in order to obtain HRV normality ranges for each participant. If the HRV value is within the normal range, the participant will perform a high intensity training but if the HRV value is below the normal range, the participant will perform a continuous training at low intensity as active rest.
| Study group | Role | What they receive |
|---|---|---|
| HIIT-based training | Experimental | The HIIT group will train according to a predefined high intensity training program Receives: Other: HIIT |
| HRV-based training | Experimental | The training prescribed to the HRV group will depend on the subjects' diary HRV Receives: Other: HRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak) changes
According to the Spanish Society of Cardiology, the modified Bruce procotol will be used as a treadmill test, as it is indicated for people considered to be at high risk and the elderly.
Measured: baseline and week 8
Secondary outcomes (13)
Heart rate variability
HRV is proposed to be measured at rest, just before the training session, in a laying position and over a 60 second period. Smartphone application known as "HRV4Training" will be used.
Measured: every day before starting the intervention
Functional performance
To measure functional capacity, the Senior Fitness Test battery will be used such as the "Six Minutes Walk Test" Or "Timed Up and Go Tests", as it has been used in previous studies in which a program based on high-intensity training has been implemented with elderly people.
Measured: Baseline and week 8
Body mass index (BMI)
Height will be measured using a measuring rod (Seca 213), and the body mass index (BMI) will be calculated according to the formula: BMI = kg/m2.
Measured: Baseline and week 8
Quality of life MacNew
the MacNew QLMI post-myocardial infarction quality of life questionnaire will be administered. Consists of a 27-question questionnaire answered on a scale of 1 to 7, where 1 means "always" and 7 means "never".
Measured: Baseline and week 8
Number of participants with abnormal laboratory test results
The blood analysis will include the lipid profile, the detection and quantification of plasma insuline and its' resistance.
Measured: baseline and week 8
Waist-to-hip ratio
As body fat distribution can vary substantially, and having into account that abdominal adiposity has been associated with coronary heart disease, Waist-to-hip ratio will be measured according to International Society for the Advancement of Kinanthropometry Standards.
Measured: Baseline and week 8
Waist-to-height ratio
In the same way, waist-to-height ratio will be also measured as a recent systematic reviews with meta-analysis have proposed it as a better predictor of cardiovascular risk factors.
Measured: Baseline and week 8
Cognitive function, spatial memory recognition test
the spatial memory recognition test (ASMRT), a simple virtual reality based task for specific population like older adults and with proved sensitivity to gender differences
Measured: baseline and week 8
Cognitive function, virtual version of the Walking Corsi test
the virtual version of the Walking Corsi test (VR_WalCT) will be used to measure topographical memory, as proved its' equivalency regarding the real environment one
Measured: baseline and week 8
Cognitive function, Trail Making Test
the Trail Making Test (TMT) will be used to detect neurological disease and neuropsychological impairment through the cognitive domains of processing speed, sequencing, mental flexibility and visual-motor skills.
Measured: baseline and week 8
Exercise Adherence
Adherence will be assessed by the number of sessions completed by the participants. At least, the 80% of the sessions should be achieved to consider a successful adherence.
Measured: up to 8 weeks
Feasibility study
Feasibility study will be considered as the compliance to the exercise protocol, and will be registered as the percentage of participants that finished every training session.
Measured: up to 8 weeks
Safety study
Safety study will be measured as the numbers of adverse events occurred during the training sessions. They will be registered as mild, moderate and severe. Moreover, their relation to the exercise session will also be taken into account.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- CEINSA, University of Almeria
- Responsible party
- Principal investigator, María Carrasco Poyatos, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612776
- Sponsor's protocol ID
- AHIITATE
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training (HIIT) vs Heart Rate Variability (HRV) Training for Cardiac and Functional Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT05612776
- Acronym / sponsor ID
- AHIITATE
- Keywords
- Heart Rate Variability, HIIT, cardiac rehabilitation, safety, adherence, VO2peak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- CEINSA, University of Almeria
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 10 Nov 2022 (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.
Consequences of stroke are manyfold but all of them are important factors on the long-term outcomes of rehabilitation, becoming an important health problem with requires health strategies with advanced age. High intensity interval training (HIIT) is an efficient training protocol used in cardiac rehabilitation programs, but owing to the inter-individual variability in physiological responses to training associated to cardiovascular diseases, the exercise dose received by each patient should be closely controlled and individualized to ensure the safety and efficiency of the exercise program. The heart rate variability (HRV) is actually being used for this purpose, as it is closely linked to de parasympathetic nervous system activation. In this way, higher scores in HRV are associated with a good cardiovascular adaptation. The objective of this protocol is to determine the effect of HIIT compared with HRV-guided training on cardiorespiratory fitness, heart rate variability, functional parameters, body composition, quality of life, inflammatory markers, cognitive function, and feasibility, safety and adherence in patients after stroke undertaking an 8-week cardiac rehabilitation program. This will be a cluster-randomized controlled protocol in which patients after stroke will be assigned to an HRV-based training group (HRV-G) or a HIIT-based training group (HIIT-G). HIIT-G will train according to a predefined training program. HRV-G training will depend on the patients' daily HRV. The peak oxygen uptake (VO2peak), endothelial and work parameters, the heart rate variability, the functional parameters, the relative weight and body fat distribution, the quality of life, the inflammatory markers, the cognitive function, and the exercise adherence, feasibility and safety will be considered as the outcomes. It is expected that this HRV-guided training protocol will improve functional performance in the patients after stroke, being more safe, feasible and generating more adherence than HIIT, providing a better strategy to optimize the cardiac rehabilitation interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT-based training | Experimental | Other: HIITThe HIIT group will train according to a predefined high intensity training program |
| HRV-based training | Experimental | Other: HRVThe training prescribed to the HRV group will depend on the subjects' diary HRV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- left ejection fraction higher than 30% after stroke
- aged between 18 and 80 years old
Key exclusion criteria (5 listed)
- presence of absolute or relative contraindications for accomplishing the treadmill test, indicated by the Spanish Society of Cardiology
- being treated for other diseases, or regularly taking a drug(s) that has a direct or indirect effect on the nervous system (e.g., anxiolytics, antidepressants or neuroleptics)
- absence of medication to control the cardiovascular disease or its modification during the intervention
- people who are participating or have participated in the previous three months in other similar exercise programs
- not performing at least 80% of the workouts during the intervention
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 |
|---|---|---|
| HIITHIIT training will consist of performing high intensity intervals along with passive rests. The intensity of the exercise will be progressively increased and the rest time will be decreased. All participants will perform the same training according to the maximum heart rate reached in the Bruce test. | Other | HIIT-based training |
| HRVThe intervention group will perform HRV-based training, measuring HRV every day before training in order to obtain HRV normality ranges for each participant. If the HRV value is within the normal range, the participant will perform a high intensity training but if the HRV value is below the normal range, the participant will perform a continuous training at low intensity as active rest. | Other | HRV-based training |
Primary outcome
Peak oxygen uptake (VO2peak) changes
Time frame: baseline and week 8
According to the Spanish Society of Cardiology, the modified Bruce procotol will be used as a treadmill test, as it is indicated for people considered to be at high risk and the elderly.
13 secondary outcomes
Heart rate variability
Time frame: every day before starting the intervention
Functional performance
Time frame: Baseline and week 8
Body mass index (BMI)
Time frame: Baseline and week 8
Quality of life MacNew
Time frame: Baseline and week 8
Number of participants with abnormal laboratory test results
Time frame: baseline and week 8
Waist-to-hip ratio
Time frame: Baseline and week 8
Waist-to-height ratio
Time frame: Baseline and week 8
Cognitive function, spatial memory recognition test
Time frame: baseline and week 8
Cognitive function, virtual version of the Walking Corsi test
Time frame: baseline and week 8
Cognitive function, Trail Making Test
Time frame: baseline and week 8
Exercise Adherence
Time frame: up to 8 weeks
Feasibility study
Time frame: up to 8 weeks
Safety study
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and HRV in people with Stroke and Cardiac Disease, run by Universidad de Almeria at 1 site in Spain.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Carrasco, PhD (+34950214773 ext. 84773, carrasco@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO2peak) changes (time frame: baseline and week 8). 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 10 Nov 2022.