跳至主要内容
临床试验/NCT04711785
NCT04711785撤回不适用

Assessment of the Possible Beneficial Effects of an Integrated Program of Multicomponent Physical Exercise Tutored at Home Through an Integrated Computer System. Cohort Study

Hospital de la Ribera1 个研究点 分布在 1 个国家开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Intrinsic capacity

研究概览

简要总结

The study has been designed to analyze the possible positive effects of a multicomponent physical exercise program monitored with an integrated electronic device system in dwelling-community frailty older adults.

The study will assess changes in physical, nutritional, cognitive, and psychological aspects after program finishes at six months.

Information will be collected by researchers at baseline, monthly and after study finishes.

详细描述

The aging process is associated with physiological changes that determine a decrease in functional reserve and limit the ability to respond to external factors.

Likewise, aging is associated with a deterioration of the regulatory processes that maintain the functional integration of the different organs and systems. A direct consequence of this phenomenon is the atypical presentation of highly prevalent diseases in the elderly. This atypical presentation of diseases in the elderly is responsible for the so-called geriatric syndromes, considered as specific nosological entities with a high frequency of presentation in the elderly, being included within the prevention, diagnosis and treatment strategies of geriatric medicine.

These syndromes can generate greater morbidity and consequences, sometimes more serious than the disease that produces them. Its systematic detection should be included in the anamnesis of the clinical history of the elderly. Geriatric syndromes are a group of conditions usually caused by the conjunction of diseases with a high prevalence in the elderly and which are the frequent origin of functional or social disability in the population. They are the manifestation of many diseases, but they are also the beginning of many other problems that we must take into account from their detection to establish a good prevention of them.

The hypothesis of this work is that in frail and pre-frail older adults who participate in an integrated program of multicomponent physical exercise tutored by means of an app will improve their functional situation and reverse their diagnoses of pre and frailty.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Cohort study no masking presented.

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
是

入选标准

  • •Informed consent signature

排除标准

  • •Life expectancy less than 6 months
  • •Acute Ischemic coronariopathy event during the last three months
  • •Active cancer treatment (chemoteraphy or radiotherapy) during the last three months
  • •Major surgery during the last six months

研究组 & 干预措施

Intervention

Active Comparator

Multicomponent exercise program twice a week (2 hours per week) during six months

干预措施: Multicomponent exercise program (Behavioral)

Control Goup

No Intervention

Usual routine.

结局指标

主要结局

Intrinsic capacity

时间窗: Six months

ICOPE questionnaire score

Frailty reversion.

时间窗: Six months

Linda Fried's frailty criteria. Score 0 Fit, 1-2 Prefrail, 3 or over Frail

Quality of life objective and subjective

时间窗: Six months

EuroQool 5 Dimensions (EQ-5D). Objective score 0 to 10.

Polypharmacy

时间窗: Six months

Quantitative definition. Considered polypharmacy the daily intake of 5 or more drugs.

Cognitive state

时间窗: Six months

Pfeiffer questionnaire

Nutrition state

时间窗: Six months

Mini Nutritional Assessment Short Form. Score 0 to 14.

Falls

时间窗: Six months

Number of falls during follow-up period

Depression

时间窗: Six months

Yesavage's Geriatrics Depression Scale (15 items)

Sarcopenia

时间窗: Six months

European Working Group on Sarcopenia in Older People (EWGSOP) criteria

次要结局

  • Validation of a gait speed mobile phone tool(Six months)
  • Validation of a shaking measurement tool to asses muscle strength(six months)
  • Hospital admissions(Six months)
  • Visits to General Practitioner (GP)(Six months)
  • Validation of a pulmonar capacity mobile phone tool(six months)

研究者

发起方
Hospital de la Ribera
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Jose Tarazona-Santabalbina

MD, Ph D

Hospital de la Ribera

研究点 (1)

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