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临床试验/NCT03690258
NCT03690258Unknown不适用

The Effects of Variable Load Exercise on Muscle Function and Blood Pressure Regulation: a Randomized Controlled Trail

University Hospital of Split2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Non invasive surface electromyography (HD EMG, in mV) during MVC (maximal voluntary contraction, Nm), Peak oxygen uptake assessment (VO2; ml kg min-1)

研究概览

简要总结

The primary aim of this research proposal is to examine whether this novel training program approach is capable to tackle excessive loss in muscle mass, function and contractile capacity with aging. Previous investigations have universally shown a dramatic loss in type II muscle fibers, while certain countermeasures in their follow-up studies were generally ineffective and limited to attenuate this phenomenon. Probably, they failed to meet recruitment threshold of larger motor units and subsequently innervate type II muscle fibers. Furthermore, previous investigations also failed to provide any data on specific blood markers that may provide additional insight into muscle fiber loss with aging. Muscle fibers type II play a crucial role in the human ability to produce as much as force as possible over a limited time-frame (e.g. 100-200 ms) to counteract unexpected perturbations during stair climbing for example and thus avoiding falls. Therefore, this data collection would be noteworthy in particular, especially for this population due to health-related outcomes and healthy aging process.

Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, data collected may aid in development of safety guidelines and protocols aimed at reducing health risks in this specific population. Importantly, in case the aforementioned hypotheses are confirmed, present findings may offer important information to the healthcare system, especially for reducing economic burden.

详细描述

This study is being conducted to determine whether a novel training approach (variable load exercise) is an effective countermeasure to attenuate for rapid declines in muscle power, function, contractile capacity and fiber type distribution that typically originate from aging and muscle disuse.

The present study is planned over a 24-month investigation period, including ethics application write-up, equipment calibration, participant recruitment, general health examination, familiarization trails, pilot study, data collection in the main portion of the study, data analysis and paper write-up for peer-review journal.Collaboration with Institute for Kinesiology Research of Koper (a municipality in Slovenia), University of Split, University of Udine and Padua is planned. In addition, recruitment of students of Applied Kinesiology at University of Primorska, to collaborate on data collection so they could use data acquired to write their final papers or master thesis is also planned.

After obtaining ethical approval, seniors will be recruited from the Primorska region in Slovenia, via presentations in Daily Activity Centers, social medial and local newspaper. Exclusion and inclusion criteria will be applied as outlined in the next paragraph and those applicants remaining will be randomized into different groups. Data collection will be carried out on eight separate occasions, including familiarization, pilot testing, main portion of the study and follow up data collection, in a randomized counter balance crossover fashion. Following familiarization and pilot study all participants will be randomly assigned to either (I) RT or (II) variable load exercise (VLE) before a crossover of experimental protocols is executed, after a minimum washout period (2x times the duration of experimental protocol) and a follow-up measurement will take place two weeks after experimental protocols are completed. Each participant will be allocated into RT or VLE with pre/post measurements preceding each condition, for eight consecutive weeks following a structured linear periodization model, previously used in healthy older adults (Colon et al., 2017). In total of 2 weeks of familiarization period (to ensure reliability of assessment and avoid learning effects), 4 weeks of pilot study (comparing old and young participants) 16 weeks of different training protocols (RT and VLE, plus 4 weeks of washout period) accompanied with follow-up measurements two weeks after completing training protocols, since training effects are in general dose-dependent and their effects are reversible. Lastly, testing procedures will be conducted at the same facility, by the same researchers using the same equipment at the similar time of the day across the investigation.

The selection of participants will consist of both male and female adults established on a purely voluntary basis. We will follow a strict inclusion and exclusion criteria (in brief):

  1. Inclusion criteria: (Signed informed consent and doctor's permission; Age >50 years)
  2. Exclusion criteria: (Any cardiovascular disease or ECG examination abnormalities (at rest and under load); hypertension (resting BP > 140/90 mm Hg); previous history of musculoskeletal and neurological disorder/injury; previous history of neurological disorders; supplement or drug consumption that may interfere with training outcomes; alcohol consumption and smoking; BMI >30 kg/m2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Researches collecting data will be blinded of participant allocation.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion criteria:
  • •Both genders will be included;
  • •signed informed consent and doctor's permission;
  • •Age >50 years;
  • •BMI <30 kg/m2,
  • •At least 30 minutes of daily moderate-to-vigorous physical activity during (including five days of monitoring prior to any data collection).

排除标准

  • •Severe cardiovascular diseases;
  • •hypertension prevalence (>140/90 mm Hg).
  • •history of severe musculoskeletal and neurological disorders/injuries;
  • •history of severe neurological disorders;
  • •supplement or drug consumption that may interfere with training outcomes;
  • •alcohol consumption and smoking;
  • •use of walking aids;
  • •The risks and benefits will be outlined to each participant before inclusion into the study.
  • •Data collection risks include potential transient discomfort from the venipuncture blood sampling and muscle soreness originating from experimental training protocols. The participants will get valuable information on how their muscles adapt following systematic training protocols.

研究组 & 干预措施

Variable load exercise

Experimental

Variable load intervention (The nHANCE-squat ultimate - iso-inertial load, with power output in watts performed 3 x per week) will being performed to determine whether this training approach is an effective countermeasure to attenuate for rapid declines in muscle power, function, contractile capacity that typically originate from aging and muscle disuse. Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, we could develop safety guidelines and protocols aimed at reducing health risks in seniors.

Data available at: http://nhance.se/

干预措施: Variable load exercise (Device)

Variable load intervention

Experimental

This study is being conducted to determine whether this variable load (The nHANC dead lift - eccentric overload performed 3 x per week for 4-6 weeks) intervention is an effective countermeasure to modulate blood pressure in seniors. Since age-related incline in resting blood pressure (hypertension) is accelerated already after short bouts of physical inactivity, any attempt to counteract age-related and disuse-related decline have high clinical significance. In addition, we aim to examine endothelial function via non-invasive flow mediated dilatation (FMD) technique.

Based on the findings, we could develop safety guidelines and protocols aimed at reducing health risks in this specific population. Importantly, in case present hypotheses are confirmed, this may offer important information to the healthcare system, especially for reducing economic burden.

干预措施: Variable load exercise (Device)

结局指标

主要结局

Non invasive surface electromyography (HD EMG, in mV) during MVC (maximal voluntary contraction, Nm), Peak oxygen uptake assessment (VO2; ml kg min-1)

时间窗: 12-24 months

Pulmonary ventilation and oxygen uptake at rest and during cycling. All data will be collected via a portable system (K5 RQ, Cosmed, Rome, Italy)

Continuous blood pressure monitoring via photopletismograpy (via Finometer) and non-invasive hemodynamics assessment

时间窗: 12-24 months

Non-pharmacological intervention (exercise intervention); To address motor unit recruitment pattern with pre-post intervention data collection scheme.

次要结局

  • Endothelial function (via non invasive flow mediated dilatation technique(12-24 months)

研究者

发起方
University Hospital of Split
申办方类型
Other
责任方
Principal Investigator
主要研究者

Damir Zubac

PhD

University Hospital of Split

研究点 (2)

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