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临床试验/NCT03526653
NCT03526653已完成不适用

Physical and Cognitive Exercises in Nursing Homes: Is Frailty Reversible?

Hasselt University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年4月1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
入组人数
10
试验地点
2
主要终点
Brain Derived Neurotrophic Factor (BDNF)

研究概览

简要总结

Elderly in residential care spend 97% of their time sedentary. Moreover, exercise therapy often takes place in a poorly stimulating environment which is less motivational for the elderly to undertake regularly. Exercise is however necessary to preserve their physical capabilities and to limit their care dependence.

The aim of this study is to investigate the most motivating and stimulating exercise modality for prefrail and frail elderly in nursing homes with which they can reach sufficient training volume.

To study this, elderly will exercise in 3 different ways on an ergometer or motomed (according to their physical capabilities): 1) in an environment without other visual stimuli 2) in front of a television with National Geographic images 3) with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner.

MemoRide (Activ84Health) uses Google Street View images. The starting point is a connection between an exercise bike and a tablet with a pedalling sensor. This way, pedal frequency is sent to the tablet and as a result, images continue when pedalling.

The forth modality is the control modality, in which participants are instructed to rest (supine) during 30 minutes.

Based on objective training parameters and metabolic parameters e.g. glucose, insulin, brain-derived neurotrophic factor (BDNF) and lactate, (via a blood sample with a venous catheter) the training modality which offers the best training results will be studied. Secondly, also subject experiences (motivation and emotions) will be evaluated by using questionnaires and observation scales.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women with an age of at least 70 years at the start of the study;
  • Staying for at least one month in WZC St. Elisabeth Hasselt at the start of the study;
  • Being frail or prefrail (according to the criteria of Fried);
  • Being available to participate in the study during 4 consecutive weeks;
  • Being able to actively exercise on an exercise bike (if necessary from a wheelchair) during at least 5 minutes;
  • Understand simple instructions.

排除标准

  • Any neurological or orthopedic disease which makes it impossible to exercise by bike actively e.g. stroke with hemiparesis of the lower limbs, amputations of the lower limbs,…;
  • Any disease which makes it impossible to exercise actively e.g. heart failure;
  • Any neurological or orthopedic disease from which progression (e.g. hip prosthesis, acute stroke) due to active recovery or decline (e.g. ALS (amyotropic lateral sclerosis), MS) due to the disease process can be expected on short term (1-2 months);
  • Being blind or visually impaired;
  • Any acute disease on the moment of the intervention which makes it impossible to exercise by bike during 30 minutes (e.g. hyper- or hypoglycemia) (reported by the caregiver)

结局指标

主要结局

Brain Derived Neurotrophic Factor (BDNF)

时间窗: minute 30

a protein produced inside the brain which can be transported outside the brain - it probably has a protective effect on neuronal survival and maintenance during adulthood

Distance immediately post-intervention

时间窗: minute 30

evaluation of distance via data on the exercise bike

Fatigue

时间窗: minute 30

evaluation of perceived exertion via the BORG-scale

Velocity

时间窗: minute 30

evaluation of velocity via data on the exercise bike and pedalling sensor

Credibility-Expectancy Questionnaire

时间窗: minute 30

evaluation of motivation via Credibility-Expectancy Questionnaire

Observed Emotion Rating Scale

时间窗: minute 30

evaluation of emotions via an observation scale (Observed Emotion Rating Scale)

Intrinsic Motivation Inventory

时间窗: minute 30

evaluation of motivation via Intrinsic Motivation Inventory questionaire

次要结局

  • Glucose(minute 30)
  • Insulin(minute 30)
  • depressed feelings(baseline)
  • Heart rate(minute 30)
  • systolic and diastolic blood pressure(minute 30)
  • Lactate(minute 30)

研究者

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

Dominique Hansen

Principal Investigator

Hasselt University

研究点 (2)

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