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临床试验/NCT05748821
NCT05748821招募中不适用

Acute Effects of Autoregulated and Non-autoregulated Blood Flow Restrictive Bicep Curls on Indices of Arterial Stiffness and Muscle Morphology

Salisbury University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Beta-Stiffness Index

研究概览

简要总结

The purpose of this study is to investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) blood flow restriction (BFR) bicep curls on indices of arterial stiffness. We are attempting to differentiate physiological changes with AR and NAR bicep curl exercise. Twenty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), AR BFR and NAR BFR) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). After a familiarization session with the BFR device, subjects will perform arm curls during the three treatment sessions with 4 sets to failure with a 2 seconds concentric and 2 seconds eccentric cadence, at 20% 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the effects of treatment and the treatment-order interaction on pulse wave velocity, beta-stiffness index, and augmentation index.

详细描述

Visit 1: Familiarization session. Resting BP; urine sample (female participants only); carotid artery ultrasonography, applanation tonometry anthropometric measurements; body composition measurement; arm curl 1 RM (Appendix 1), familiarization of arm curl exercise with BFR device which includes performing four sets with repetitions (rep) of 30, 15, 15, and 15 at 20% of 1RM with 1 minute of rest between sets.

Visit 2 - 4: Treatment session. Carotid artery ultrasonography, applanation tonometry, and vastus lateralis ultrasonography before and immediately after arm curl exercise. Arm curl exercise with randomized no-BFR or BFR device (auto- or nonautoregulated) will be set at 60% of LOP in supine position) and will include four sets to failure at 20% of 1RM with 2 seconds concentric and 2 seconds eccentric movements per repetition and 1 minute of rest between sets. Cadence will be maintained with an electronic metronome.

The familiarization and treatment sessions will be separated by 1-week.

Devices and Measurements Pregnancy Test. This procedure requires collection of 2-3 teaspoons of urine from all female subjects in a testing cup. Indicator strips (Sekisui Diagnostics OSOM hCG Urine Test Kit, 100% specificity and sensitivity) will be used to test for pregnancy. The P.I. will instruct the participant on the procedure for urine collection. The collection will be completed in a bathroom in Devilbiss Hall. The participant will be instructed to wipe the outer urethra with Castile Soap Towelettes before urinating into a disposable urine collection cup. She will fill the cup with urine, replace the lid and place the cup on a shelf in the bathroom. If the subject is pregnant or the test indicates a current pregnancy, the participant will be immediately notified and will not be able to participate in this study. The participant will be recommended to visit Salisbury University's Student Health Center located in Holloway Hall, room 180 (for SU students) or Wicomico County's Health Department located on 108 E. Main Street in downtown Salisbury, MD for additional support and guidance. The medical waste will be disposed of properly in the Biohazard container inside Devilbiss Hall 316. Spills will be collected with absorptive, disposable towels and surface will be wiped clean with Clorox Wipes. The PI will conduct all the pregnancy tests and the results will be kept confidential.

Autoregulated (AR) and non-autoregulated (NAR) BFR training devices. AR and NAR BFR training devices (Delfi, Vancouver, Canada) will be used for all exercise and testing sessions (Appendix 2). Cuffs will be placed around the right and left proximal arm. The LOP will be set at 60% immediately before exercise and will be applied during the entire exercise set (approximately 30-60 seconds in duration). The AR BFR training device will maintain 60% of the LOP during the entire range of motion. Its diameter will increase during the concentric phase to accommodate the muscle enlargement and decrease during the eccentric phase to accommodate muscle reduction. The NAR BFR training device will also have the LOP set at 60% but the tension will not be constant during the entire range of motion. This is because the diameter of the cuff will not change during the concentric and eccentric phases, causing greater pressures to occur in the thigh during the concentric phase. The LOP will be decreased to 0% immediately after the set is completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-40 years old
  • Physically active (> 6 months of consistent exercise training)
  • Weight stable for previous 6 months (+/-2.5 kg)
  • Female subjects only- reported regular menstrual cycles for the last 2 years

排除标准

  • BP>140/90 mmHg
  • BMI>40 kg/m2
  • Familial hypercholesterolemia
  • Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
  • Women must not be pregnant, plan to become pregnant during the study, or be nursing
  • Active renal or liver disease
  • All medications and supplements that influence dependent variables
  • Recent surgery < 2 months
  • Alcohol abuse
  • Sleep apnea
  • Claustrophobia

结局指标

主要结局

Beta-Stiffness Index

时间窗: 10 minutes after exercise trial.

A measurement that compares carotid SBP and DBP with carotid systolic and diastole diameters.

Carotid-femoral pulse wave velocity

时间窗: 15 minutes after exercise trial.

A measurement that records the time difference between the foot of the systolic wave form as it arrives at the carotid and femoral arterial sites. It is measured with an arterial tonometer.

次要结局

未报告次要终点

研究者

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

Timothy Werner

Associate Professor

Salisbury University

研究点 (2)

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