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临床试验/NCT05744167
NCT05744167已完成不适用

Resistance Training and Muscle - Brain Crosstalk

Lithuanian Sports University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in cognitive function on the Switching task (executive function)

研究概览

简要总结

BRAIN-M is a randomized controlled trial designed to examine the effects of a single bout or 12 weeks of blood-flow restriction training or high-intensity resistance training on cognitive function, brain health, muscular properties and physical performance in healthy older men 60-75 years old.

详细描述

The BRAIN-M project is driven by the idea that understanding the mechanisms through which muscle and brain interact could offer new approaches to magnifying the beneficial and detrimental effects of exercise training on health at older age. Specifically, the investigators aim at identifying brain, blood, and muscle biomarkers that could serve as predictors of response to exercise training at either cognitive, brain, muscle or physical performance levels and study the associations between biomarkers in order to suggest a physiological model of brain-muscle and muscle-brain crosstalk in ageing. 60 male older adults (60-75y old) will be included in either 12 weeks of high-intense blood-flow restriction training (n = 20), muscle damaging resistance training (n = 20) or no exercise (n = 20). The control group will be asked to maintain their usual lifestyle.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •healthy male older adults
  • •able to speak and read fluent Lithuanian
  • •living in community during the study

排除标准

  • •cognitive and neurological disorders (e.g. dementia, stroke, Parkinson, multiple sclerosis)
  • •previous lower extremity injury
  • •diabetes mellitus type I or II
  • •no oncologic disease
  • •no bone fractures in the previous year
  • •deep vein thrombosis
  • •cardiovascular disorders (e.g. congestive heart failure, angina pectoris, uncontrolled arrhythmia, history of myocardial infarction or coronary bypass grafting in the past year)
  • •obesity (BMI >30kg/m²)
  • •chronic fatigue, chronic headache, or chronic dizziness
  • •ineligibility to MRI scanning (e.g. due to claustrofobia or metal implants)
  • •The participants should not be engaged in any regular exercise programme during the previous 6 months (according to IPAQ), but able to perform 10 sit-ups
  • •Any other consideration that interferes with the study aims and/or risk to the participant, at the discretion of the researcher

研究组 & 干预措施

Blood flow restriction training (BFRT)

Experimental

Participants will engage in a supervised 12-week lower extremity resistance exercise program, 2 times per week. BFRT will be at an intensity of 40% of 1RM with an occlusive cuff placed at the proximal end of both lower extremities to restrict the return of blood flow. The cuff will be inflated to 50% of the limb occlusion pressure in the first week, which will be increased with 10% every week during the first 4 weeks to reach a maximum of 80% limb occlusion pressure on week 4 that will be kept for the remaining 9 weeks of the program. Each exercise will be performed for 4 sets of 12 repetitions with a 30-second rest period between sets and 3 minutes rest between exercises without occlusion.

干预措施: BFRT (Behavioral)

Muscle damaging resistance training (MDRT)

Experimental

Participants will engage in a supervised 12-week lower extremity resistance exercise program, 2 times per week. MDRT will be at an intensity of 80% or 120% of 1RM. The first session will be at 120% 1RM and consist of eccentric-only exercises. The concentric phase of the movement will be supported completely by a coach. The eccentric phase of the movement will be accentuated by increasing the time under tension to six seconds. Each exercise will be performed for 4 sets of 4 repetitions with 2 minutes rest between sets and 3 minutes rest between exercises. The eccentric-only exercise session will be followed by 2 (after the first session) or 3 (after all other sessions) concentric-only exercise sessions at 80% of 1RM. Here, the eccentric phase of the movement will be supported completely by a coach. In the 12 week period, there will be a total of seven eccentric-only exercise sessions.

干预措施: MDRT (Behavioral)

Control group

No Intervention

Control group will be asked to maintain their usual lifestyle.

结局指标

主要结局

Change in cognitive function on the Switching task (executive function)

时间窗: Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period

The switching task is a complex task where subjects need to switch (executive function) between a manikin task (visuospatial skill, attention and problem solving) and a mathematical computation task (mathematical computation skill, concentration and working memory).

次要结局

  • Changes in quadriceps muscle fiber type(Before and after the 12 week intervention period)
  • Changes in maximal isometric strength (with Biodex)(Before and after the 12 week intervention period)
  • Change in cognitive function on the 2-Choice Reaction time (processing speed), Go/No-Go (inhibition) or 6 letter Memory Search (memory) test(Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period)
  • Changes in blood serum levels of TNFalpha and syndecan(Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout)
  • Changes in blood serum levels of IGF-1, IL-6 and kynurenine(Before and after the 12 week intervention period)
  • Changes in patellar tendon crossectional area(Before and after the 12 week intervention period)
  • Changes in muscle contractile characteristics (with tensiomyography (TMG))(Before and after the 12 week intervention period)
  • Changes in quadriceps muscle thickness(Before and after the 12 week intervention period)
  • Changes in BMI(Before and after the 12 week intervention period)
  • Changes in SMI(Before and after the 12 week intervention period)
  • Changes in quadriceps muscle fascicle angle(Before and after the 12 week intervention period)
  • Changes in handgrip strength(Before and after the 12 week intervention period)
  • Changes in lactate levels(Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout)
  • Changes in blood plasma levels of BDNF(Before first exercise bout, immediately after first exercise bout, 1 hour after the first exercise bout and after the 12 week intervention period)
  • Changes in fat free mass(Before and after the 12 week intervention period)
  • Changes in patellar tendon stiffness(Before and after the 12 week intervention period)
  • Changes in quadriceps muscle fascicle length(Before and after the 12 week intervention period)
  • Changes in quadriceps muscle intramuscular fat(Before and after the 12 week intervention period)
  • Changes in brain white matter volume (with magnetic resonance imaging)(Before and after the 12 week intervention period)
  • Changes in isokinetic peak torque (with Biodex)(Before and after the 12 week intervention period)
  • Changes in subjective sleep quality (patient reported outcome questionnaires)(Before and after the 12 week intervention period)
  • Changes in blood CK levels(Before first exercise bout and every 3 weeks for a total of 7 times 48 hours after the eccentric-only training session in the MDRT group.)
  • Changes in body fat %(Before and after the 12 week intervention period)
  • Changes in quadriceps muscle cross-sectional area(Before and after the 12 week intervention period)
  • Changes in brain neural integrity (with proton magnetic resonance spectroscopy)(Before and after the 12 week intervention period)
  • Changes in brain neuroinflammation (with proton magnetic resonance spectroscopy)(Before and after the 12 week intervention period)
  • Changes in reported physical activity levels (patient reported outcome questionnaires)(Before and after the 12 week intervention period)
  • Changes in brain gray matter volume (with magnetic resonance imaging)(Before and after the 12 week intervention period)
  • Changes in brain neuroplasticity marker (with proton magnetic resonance spectroscopy)(Before and after the 12 week intervention period)
  • Changes in balance (with posturography on Kistler platform)(Before and after the 12 week intervention period)
  • Changes in rate of force development (with Biodex)(Before and after the 12 week intervention period)
  • Changes in physical performance (with the Fitness Fullerton Test battery for the Senior)(Before and after the 12 week intervention period)
  • Changes in subjective quality of life (patient reported outcome questionnaires)(Before and after the 12 week intervention period)
  • Changes in nutrition (patient reported outcome questionnaires)(Before and after the 12 week intervention period)

研究者

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

Vilma Dudoniene

Associated professor

Lithuanian Sports University

研究点 (1)

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