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临床试验/NCT05144815
NCT05144815已完成不适用

Effectiveness of an Endurance Exercise Programme Preceded by Ischaemic Preconditioning in Older People: a Randomised Clinical Trial

University of Valencia2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年11月12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
31
试验地点
2
主要终点
Heart rate variability during walking

研究概览

简要总结

In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018).

In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, & Harridge, 2019).

A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, & Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, & Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking.

Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.

详细描述

In recent decades, the proportion of people over 65 years of age is increasing rapidly, due to rising life expectancy and declining fertility rates. According to the World Health Organization, people in this age group will constitute 22% of the population by 2050, up from the current 12% (WHO, 2018). Therefore, improving quality of life (healthspan) and preventing disability has become a public health challenge (Olshansky, 2018).

In this context, physical exercise has been shown to be able to prevent sarcopenia, functional decline, the presence of chronic diseases and even mortality in this group (Izquierdo et al., 2021; Lazarus, Lord, & Harridge, 2019).

Resistance or endurance training can improve sarcopenia, reduce intramuscular fat accumulation, improve muscle function, among others. Aerobic exercise has been shown to be effective in maintaining muscle mass and strength in older adults is walking (Kubo et al., 2008). In fact, walking can also improve VO2max in older adults when intensities are above ∼40% VO2max (Nemoto, Gen-no, Masuki, Okazaki, & Nose, 2007). In addition, it has been linked to the prevention of cognitive decline (Maki et al., 2012) and improvements in quality of life (Awick et al., 2015) in older people.

A training method that could enhance the benefits of walking is ischaemic preconditioning (IPC), characterised by the application of brief periods of circulatory occlusion-reperfusion to a limb, minutes to hours prior to exercise. This type of intervention, initially used to delay/prevent cell damage in patients with myocardial infarction (Murry, Jennings, & Reimer, 1986), has recently shown beneficial effects in young people to improve physical performance in a wide variety of sports (Caru, Levesque, Lalonde, & Curnier, 2019), as well as to improve recovery from associated muscle damage (Franz et al., 2018), which is of particular interest in the adult population. In fact, the application of IPC alone for two weeks has been shown to improve walking speed and reduce fatigue in post-stroke patients (Durand et al., 2019), promising effects that could be increased when applied prior to resistance training, such as walking.

Thus, the objective of this study is to determine the effectiveness of an endurance exercise programme preceded by ischaemic preconditioning on parameters related to physical function, cognitive status and quality of life in older people. In addition, we set out to compare the acute and chronic effect of the proposed interventions.

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
Single (Participant)

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 65 -90 years
  • •Physically inactive (< 150 minutes of physical activity per week).
  • •Signed informed consent form

排除标准

  • •Institutionalised patients.
  • •History of stroke in the last 6 months or hospital admission for any reason in the last 3 months.
  • •Uncontrolled hypertension.
  • •Medication with anticoagulants.
  • •Oncological patient with active treatment: chemotherapy or radiotherapy.
  • •Neurological or cardiovascular musculoskeletal pathology that contraindicates physical activity.
  • •Cognitive impairment (score below 25 on the "Mini-mental Test"); or severe disability (score below 15 points on the Barthel scale).
  • •Completion of less than 80% of training sessions.

研究组 & 干预措施

IPC + Exercise protocol group

Experimental

Patients in this group (n=16) will undergo ischaemic preconditioning (IPC) plus an endurance training protocol.

干预措施: IPC + Exercise protocol (Other)

Sham IPC + Exercise protocol group

Sham Comparator

Patients in this group (n=16) will undergo sham ischaemic preconditioning (IPC) plus an endurance training protocol.

干预措施: Sham IPC + Exercise protocol (Other)

结局指标

主要结局

Heart rate variability during walking

时间窗: 40 minutes

Heart rate monitor RS800CX (Polar Electro Oy Kempele, Finland).

Cardiorespiratory fitness

时间窗: 8 minutes

"6 minutes walking test" (6MWT)

次要结局

  • General physical condition(5 minutes)
  • Health-related Quality of Life(2 minutes)
  • Lower limb strength: for the assessment of isometric strength(10 minutes)
  • Muscle mass (sacopenia)(3 minutes)
  • Fatigue(1 minute)
  • Independence in basic activities of daily living (BADL) and instrumental activities of daily living (IADL)(5 minutes)
  • Fall risk, agility and dynamic balance(3 minutes)

研究者

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

Marta Inglés de la Torre

Professor

University of Valencia

研究点 (2)

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