HIIT vs HRV-based Training for Rehabilitation After Stroke

NCT05612776 | Unknown

• 1 other identifier: AHIITATE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cardiac Disease; Ischemic Stroke; Ischemic Heart Disease; Stroke, Ischemic

Keywords

Heart Rate Variability; HIIT; cardiac rehabilitation; safety; adherence; VO2peak

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and week 8

Secondary Outcomes (13)

• Heart rate variability

  every day before starting the intervention

• Functional performance

  Baseline and week 8

• Body mass index (BMI)

  Baseline and week 8

• Quality of life MacNew

  Baseline and week 8

• Number of participants with abnormal laboratory test results

  baseline and week 8

Study Arms (2)

HIIT-based training

EXPERIMENTAL

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

Other: HIIT

HRV-based training

EXPERIMENTAL

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

Other: HRV

Interventions

HIIT OTHER

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.

HIIT-based training

HRV OTHER

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.

HRV-based training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead
• CEINSA, University of Almeria: collaborator

Study Sites (1)

CITE III

Almería, 04120, Spain

RECRUITING

MeSH Terms

Conditions

Stroke; Heart Diseases; Ischemic Stroke; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

María Carrasco, PhD

CONTACT

+34950214773; carrasco@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: November 10, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

ES (1)