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临床试验/NCT06053229
NCT06053229招募中不适用

The Effect of Percussive Massage on the Maintenance of Skeletal Muscle and Vascular Health During Limb Immobilization

Brigham Young University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年3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
36
试验地点
2
主要终点
knee extensor muscle strength

研究概览

简要总结

The primary aims of this study are to determine the effect of percussive massage (30 min/session, 2 sessions/day, daily) during 10 days of unilateral limb immobilization on preserving muscle, vascular, and mitochondrial function. The following hypotheses will be tested:

Hypothesis 1: Percussive massage will attenuate the loss of size, strength and endurance over the immobilization period compared to the control group, as measured by MRI, maximal isometric and isokinetic force production and muscle endurance test using Biodex dynamometry.

Hypothesis 2: Percussive massage will attenuate the loss of vascular function and blood flow compared to the control group as measured by passive leg movement and femoral artery blood flow.

Hypothesis 3: Percussive massage will attenuate the loss of skeletal muscle mitochondrial function and decrease H2O2 production during immobilization compared to the control group, as measured by high-resolution respirometry.

详细描述

Phase 1. Pre-measures: Pre-measures will occur over the course of 2 days.

Visit 1:

MRI scan: Participants will report to the MRI facility and fill out an MRI safety screening form. Upon completion, a 3-Tesla magnet will be used to image their left thigh (for more detail on MRI protocol see section 7.4 below).

Visit 2:

Blood flow and vascular function measurement: Upon arrival, participants will rest on a chair for 15 minutes with their left leg resting on a rolling desktop to stabilize their heart rate and blood flow. Blood flow will be measured with Doppler Ultrasound at the Common Femoral Artery while the subjects rest and while their leg is passively moved through a 90° range of motion. This test will be repeated 3 times to determine the dilatory function of the resistance arteries of the leg.

研究设计

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

入排标准

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

入选标准

  • 18-50 years old (women are pre-menopausal). We will exclude individuals over the age of 50 because the adaptive capability of skeletal muscle fundamentally changes with older age, and the risk from disuse increases. The findings of this study will help determine the risk benefit relationship of conducting a similar study in older individuals.
  • Stable levels of physical activity for at least 6 months
  • No history of lower extremity injury that would preclude their ability to perform knee extension exercise

排除标准

  • Cigarette or marijuana smoker
  • Pregnant or planning to become pregnant within next month
  • Cardiovascular, metabolic disease or cognitive disease (e.g. Alzheimer's or mild cognitive impairment)
  • Taking prescribed medications (e.g. blood pressure medication) or anti-depressants
  • Habitual use of any type of massage or vibration on their thigh
  • Note that subjects who are mentally unable to understand the consenting process and provide informed consent will not be included in this study.

结局指标

主要结局

knee extensor muscle strength

时间窗: Immediately before the onset of leg immobilization and after 10 days of leg immobilization

Assessed by dynamometry

Vastus lateralis cross-sectional area

时间窗: Immediately before the onset of leg immobilization and after 10 days of leg immobilization

Assessed by MRI

Skeletal muscle mitochondrial function

时间窗: Immediately before the onset of leg immobilization and after 10 days of leg immobilization

Assessed in muscle biopsies using in vivo respirometry

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

Rob Hyldahl

Associate Professor

Brigham Young University

研究点 (2)

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