Clinical trial NCT05612776: HIIT vs HRV-based Training for Rehabilitation After Stroke
Official title: High Intensity Interval Training (HIIT) vs Heart Rate Variability (HRV) Training for Cardiac and Functional Rehabilitation After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cardiac Disease
Ischemic Stroke
Ischemic Heart Disease
Stroke, Ischemic
Keywords: Heart Rate Variability
HIIT
cardiac rehabilitation
safety
adherence
VO2peak
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: CEINSA, University of Almeria
First posted: 2022-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* left ejection fraction higher than 30% after stroke
* aged between 18 and 80 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: Peak oxygen uptake (VO2peak) changes
timeFrame: baseline and week 8
Secondary outcomes:
measure: Heart rate variability
timeFrame: every day before starting the intervention
measure: Functional performance
timeFrame: Baseline and week 8
measure: Body mass index (BMI)
timeFrame: Baseline and week 8
measure: Quality of life MacNew
timeFrame: Baseline and week 8
measure: Number of participants with abnormal laboratory test results
timeFrame: baseline and week 8
measure: Waist-to-hip ratio
timeFrame: Baseline and week 8
measure: Waist-to-height ratio
timeFrame: Baseline and week 8
measure: Cognitive function, spatial memory recognition test
timeFrame: baseline and week 8
measure: Cognitive function, virtual version of the Walking Corsi test
timeFrame: baseline and week 8
measure: Cognitive function, Trail Making Test
timeFrame: baseline and week 8
measure: Exercise Adherence
timeFrame: up to 8 weeks
measure: Feasibility study
timeFrame: up to 8 weeks
measure: Safety study
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Almería
country: Spain
facility: CITE III
Study officials:
References: