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临床试验/NCT07665632
NCT07665632招募中不适用

Adaptations of Vascular and Cardiorespiratory Function to a 6-week Polarized Aerobic Training Model in Apparently Healthy Individuals

University of Ljubljana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年9月25日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1

研究概览

简要总结

This randomized controlled trial will investigate the effects of a 6-week polarized aerobic training intervention on vascular and cardiorespiratory function in apparently healthy sedentary adults aged 30-50 years. Polarized training is characterized by a high proportion of low-intensity aerobic exercise combined with a smaller volume of high-intensity interval exercise, potentially providing complementary haemodynamic and physiological stimuli that support vascular adaptations and cardiovascular health. Although polarized training has been extensively studied in athletic populations, its effects on vascular function in sedentary adults remain insufficiently understood.

Thirty participants will be randomly assigned in a 1:1 ratio to either a supervised polarized aerobic training group or a non-exercising control group. The intervention will consist of a 6-week supervised cycle ergometer training program performed three times per week and prescribed according to individual ventilatory thresholds obtained during cardiopulmonary exercise testing. Training sessions will combine low-to-moderate-intensity continuous exercise and high-intensity interval exercise. Participants allocated to the control group will maintain their habitual sedentary lifestyle throughout the study period.

The primary outcome will be endothelial function assessed by brachial artery flow-mediated dilation. Secondary outcomes will include arterial stiffness assessed by pulse wave velocity, central haemodynamics, microvascular function, cardiorespiratory fitness, skeletal muscle function, pulmonary function, respiratory muscle strength, and circulating biomarkers related to vascular health. Outcome measures will be assessed at baseline and after completion of the 6-week intervention period. The findings of this study may improve understanding of vascular and systemic adaptations to polarized aerobic training and help inform future exercise-based strategies for cardiovascular risk reduction in apparently healthy sedentary adults.

详细描述

This study is a work package of the ACT-ON project and is designed to evaluate the effects of a 6-week polarized aerobic training intervention on vascular and cardiorespiratory function in apparently healthy sedentary adults. In addition, the study will investigate physiological adaptations across multiple cardiovascular, microvascular, neuromuscular, respiratory, and biochemical domains using a comprehensive multimodal assessment approach. The trial will be conducted as a single-centre, assessor-blinded, parallel-group randomized controlled trial comprising an intervention group and a non-exercising control group.

Thirty apparently healthy sedentary men and women aged 20-50 years will be recruited and randomly assigned in a 1:1 ratio to either a polarized aerobic training intervention or a non-exercising control condition. Eligible participants must not have diagnosed cardiovascular, metabolic, or renal disease, must not use medications influencing cardiovascular function, and must not engage in regular exercise training. Sedentary status will be verified using the Global Physical Activity Questionnaire (GPAQ) and current physical activity classification criteria. Participants with ambulatory blood pressure values exceeding 139 mmHg systolic and/or 89 mmHg diastolic, body mass index ≥30 kg/m², or other contraindications to exercise testing will be excluded.

Prior to enrollment, all interested individuals will attend a screening visit to confirm eligibility and ensure safe participation. The visit will be conducted in the morning and will include measurements of resting blood pressure (M7, Omron, Japan), body height (GPM, Model 101, Switzerland), body composition (InBody 720, Biospace, South Korea), and completion of the GPAQ. Female participants will additionally complete a Reproductive Status Questionnaire (RSQ) to further assess eligibility. Participants will be instructed to avoid vigorous physical activity, alcohol, and caffeine in the days preceding the visit and to arrive well rested and in a fasted state. Following the screening assessments, participants will be fitted with a 24-hour ambulatory blood pressure monitor (Boso TM-2430) to characterize habitual blood pressure status and minimize the potential influence of the white-coat effect. Written informed consent will be obtained from all participants prior to any study-related procedures.

Following enrollment and randomization, all participants will undergo comprehensive physiological assessments at the Faculty of Sport, University of Ljubljana. Baseline testing will encompass vascular and haemodynamic function, microvascular reactivity, cardiorespiratory fitness assessed by cardiopulmonary exercise testing for determination of ventilatory thresholds, skeletal muscle function, pulmonary function, respiratory muscle strength, resting blood pressure, and circulating biomarkers related to cardiovascular health and physiological adaptation to exercise.

All assessments will be performed under standardized laboratory conditions by trained investigators blinded to group allocation. Measurements of vascular and haemodynamic function will be conducted in a quiet, temperature-controlled environment (22-25 °C). Prior to testing, participants will rest in the supine position for at least 15 minutes to ensure haemodynamic stabilisation and will be instructed to refrain from caffeine, alcohol, and strenuous physical activity for at least 48 hours before each testing session. The same procedures will be repeated at least 72 hours after the final exercise session upon completion of the 6-week intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to group allocation whenever possible.

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 30-50 years
  • Apparently healthy individuals without diagnosed cardiovascular, metabolic, or renal disease
  • Sedentary lifestyle verified using the Global Physical Activity Questionnaire (GPAQ) and current physical activity classification criteria
  • Ambulatory blood pressure values within the normotensive range (<140 mmHg systolic and <90 mmHg diastolic)
  • Body mass index (BMI) <30 kg/m²
  • No regular participation in structured exercise training

排除标准

  • Ambulatory blood pressure values ≥140 mmHg systolic and/or ≥90 mmHg diastolic
  • Moderate or high physical activity level according to the Global Physical Activity Questionnaire (GPAQ)
  • Diagnosed chronic cardiovascular, metabolic, renal, respiratory, or other systemic disease
  • Use of prescribed medication influencing cardiovascular or metabolic function
  • Musculoskeletal injury of the lower extremities within the previous six months
  • Menopause
  • Absence of a regular menstrual cycle
  • Pregnancy
  • Current smoking or tobacco use

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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