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临床试验/NCT05612776
NCT05612776招募中不适用

High Intensity Interval Training (HIIT) vs Heart Rate Variability (HRV) Training for Cardiac and Functional Rehabilitation After Stroke

Universidad de Almeria1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Peak oxygen uptake (VO2peak) changes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

HIIT-based training

Experimental

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

干预措施: HIIT (Other)

HRV-based training

Experimental

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

干预措施: HRV (Other)

结局指标

主要结局

Peak oxygen uptake (VO2peak) changes

时间窗: 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.

次要结局

  • 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)
  • Waist-to-hip ratio(Baseline and week 8)
  • Waist-to-height ratio(Baseline and week 8)
  • Cognitive function, spatial memory recognition test(baseline and week 8)
  • Cognitive function, virtual version of the Walking Corsi test(baseline and week 8)
  • Cognitive function, Trail Making Test(baseline and week 8)
  • Exercise Adherence(up to 8 weeks)
  • Feasibility study(up to 8 weeks)
  • Safety study(up to 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Carrasco Poyatos

Principal Investigator

Universidad de Almeria

研究点 (1)

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