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HIIT vs HRV-based Training for Rehabilitation After Stroke

Primary Purpose

Stroke, Cardiac Disease, Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HIIT
HRV
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Heart Rate Variability, HIIT, cardiac rehabilitation, safety, adherence, VO2peak

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CITE IIIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HIIT-based training

HRV-based training

Arm Description

The HIIT group will train according to a predefined high intensity training program

The training prescribed to the HRV group will depend on the subjects' diary HRV

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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".
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.
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.
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.
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
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
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.
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.
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.
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.

Full Information

First Posted
July 19, 2022
Last Updated
November 4, 2022
Sponsor
Universidad de Almeria
Collaborators
CEINSA, University of Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT05612776
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
CEINSA, University of Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiac Disease, Ischemic Stroke, Ischemic Heart Disease, Stroke, Ischemic
Keywords
Heart Rate Variability, HIIT, cardiac rehabilitation, safety, adherence, VO2peak

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT-based training
Arm Type
Experimental
Arm Description
The HIIT group will train according to a predefined high intensity training program
Arm Title
HRV-based training
Arm Type
Experimental
Arm Description
The training prescribed to the HRV group will depend on the subjects' diary HRV
Intervention Type
Other
Intervention Name(s)
HIIT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HRV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak oxygen uptake (VO2peak) changes
Description
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.
Time Frame
baseline and week 8
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
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.
Time Frame
every day before starting the intervention
Title
Functional performance
Description
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.
Time Frame
Baseline and week 8
Title
Body mass index (BMI)
Description
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.
Time Frame
Baseline and week 8
Title
Quality of life MacNew
Description
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".
Time Frame
Baseline and week 8
Title
Number of participants with abnormal laboratory test results
Description
The blood analysis will include the lipid profile, the detection and quantification of plasma insuline and its' resistance.
Time Frame
baseline and week 8
Title
Waist-to-hip ratio
Description
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.
Time Frame
Baseline and week 8
Title
Waist-to-height ratio
Description
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.
Time Frame
Baseline and week 8
Title
Cognitive function, spatial memory recognition test
Description
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
Time Frame
baseline and week 8
Title
Cognitive function, virtual version of the Walking Corsi test
Description
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
Time Frame
baseline and week 8
Title
Cognitive function, Trail Making Test
Description
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.
Time Frame
baseline and week 8
Title
Exercise Adherence
Description
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.
Time Frame
up to 8 weeks
Title
Feasibility study
Description
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.
Time Frame
up to 8 weeks
Title
Safety study
Description
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.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Carrasco, PhD
Phone
+34950214773
Ext
84773
Email
carrasco@ual.es
Facility Information:
Facility Name
CITE III
City
Almería
ZIP/Postal Code
04120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Carrasco, PhD
Phone
950214773
Ext
84773
Email
carrasco@ual.es

12. IPD Sharing Statement

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HIIT vs HRV-based Training for Rehabilitation After Stroke

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