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临床试验/NCT05021523
NCT05021523已完成不适用

Heat Therapy to Prevent Deconditioning During Immobilization

Aspetar2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Aspetar
入组人数
20
试验地点
2
主要终点
Change in muscle protein content from baseline to post-retraining

研究概览

简要总结

Animal models suggest that heat stress increases protein content and facilitates the recovery of atrophied muscle after an immobilization period, or following a chemically induced muscle injury in rats. Thus, a recent study in human have reported that daily heat treatments, applied during 10 days of immobilization, reduced the loss of muscle mass. In addition of protecting muscle mass, repeated heat stress may also help to maintain cardiovascular fitness from the onset of injury through passive exposures in the condition that they sufficiently trigger an increase in body temperature, circulation and sweating. This study will investigate the benefits of using heat therapy to prevent deconditioning during immobilization in human.

详细描述

1.3 Background information & study rationale Heat is often used as a traditional therapy in many cultures to treat a variety of health conditions. At the level of the skeletal muscle, repeated heat exposures have been reported to increase cell proliferation and muscle protein content in vitro and in animal studies. Rodent studies have further shown that repeated heat exposure may reduce muscle atrophy during immobilization and facilitate the recovery of atrophied muscle after immobilization. The effect of heat therapy might also have numerous benefits in humans. For example, repeated passive heat exposure may improve quality of life in different populations, improve cardiovascular health, and is associated with a lower risk of fatal cardiovascular disease and all-cause mortality. Moreover, considering the association between skeletal muscle mass/function and health, two studies demonstrated that 8 to 10 weeks of repeated localized heat therapy induced skeletal muscle adaptations, increasing peak torque.

To our knowledge, the only study conducted in humans reported that daily 2-h of local heat therapy during 10 days of lower limb immobilization was sufficient to reduce vastus lateralis atrophy and maintain mitochondrial function. In rats, a single 60-minute exposure to heat an environmental chamber protects against short-term atrophy of skeletal muscle. In addition, Daily 30-min exposure to similar environmental thermal stress has also been shown to maintain mitochondrial content and oxidative capacity.

The investigators therefore conducted a first study in Aspetar showing that passive heat acclimation (11 days, 1 h per day) improves skeletal muscle contractile function during both normothermic and in the hyperthermic humans. These improvements were verified in measures obtained at rest and during contractions at different intensities ( 10, 25, 50, 75% MVC), as well as in different neuromuscular parameters: an increase in electrically evoked .peak twitch amplitude, an increase in maximal torque production at a similar level of voluntary activation, and an improvement of the relative torque/EMG linear relationship. This infers that passive heat acclimation improves skeletal muscle contractile function in humans, irrespective of thermal state. As such, this highlights a novel passive method to improve muscle function via passive heat exposure that may be used with athletes and patients during a period of musculoskeletal unloading, such as post-surgical immobilization.

1.4 Study goals and objectives The aim of the study is to investigate the benefits of using whole-body heat therapy to prevent deconditioning during immobilization in human 1.5 Study Design and Research Population

  1. Scientific justification for the research
  2. The type of study Randomized controlled trial
  3. Research population or the sampling frame

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 18 to 45 yrs old
  • Constant level of activity for at least 2 months before the start of the study
  • Fluent English speaker

排除标准

  • Contraindication to physical activity as per the Par-Q questionnaire
  • Neural pathology
  • Muscular pathology
  • Contraindication to the MRI

结局指标

主要结局

Change in muscle protein content from baseline to post-retraining

时间窗: Baseline (week 4) and week 8 (post retraining)

Muscle biopsy

Change in muscle protein content from baseline to post-immobilization

时间窗: Baseline (week 4) and week 6 (post immobilization)

Muscle biopsy

Change in maximal strength of the plantar flexors from baseline to post-retraining

时间窗: Baseline (week 4) and week 8 (post retraining)

Maximal voluntary isometric torque of the right leg (plantar flexors) in N.m

Change in muscle volume of the plantar flexors from baseline to post-immobilization

时间窗: Baseline (week 4) and week 6 (post immobilization)

MRI to measure muscle volume

Change in muscle volume of the plantar flexors from baseline to post-retraining

时间窗: Baseline (week 4) and week 8 (post retraining)

MRI to measure muscle volume

Change in maximal strength of the plantar flexors from baseline to post-immobilization

时间窗: Baseline (week 4) and week 6 (post immobilization)

Maximal voluntary isometric torque of the right leg (plantar flexors) in N.m

次要结局

  • Change in blood volume from baseline to post-immobilization(Baseline (week 4) and week 6 (post immobilization))
  • Change in maximal aerobic capacity from baseline to post-immobilization(Baseline (week 4) and week 6 (post immobilization))
  • Change in maximal aerobic power from baseline to post-retraining(Baseline (week 4) and week 8 (post retraining))
  • Change in maximal aerobic capacity from baseline to post-retraining(Baseline (week 4) and week 8 (post retraining))
  • Change in blood volume from baseline to post-retraining(Baseline (week 4) and week 8 (post retraining))
  • Change in voluntary activation of the plantar flexors from baseline to post-immobilization(Baseline (week 4) and week 6 (post immobilization))
  • Change in voluntary activation of the plantar flexors from baseline to post-retraining(Baseline (week 4) and week 8 (post retraining))
  • Change in maximal aerobic power from baseline to post-immobilization(Baseline (week 4) and week 6 (post immobilization))
  • Changes in ankle proprioception from baseline to post-immobilization(Baseline (week 4) and week 6 (post immobilization))
  • Changes in ankle proprioception from baseline to post-retraining(Baseline (week 4) and week 8 (post retraining))

研究者

发起方
Aspetar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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