跳至主要内容
临床试验/NCT04576598
NCT04576598招募中不适用

Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific Self-management Program

University of Valencia4 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
4
主要终点
Change from Baseline Physical activity level at a year

研究概览

简要总结

Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account.

Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty.

To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having sequelae after stroke of at least 6 months of evolution
  • being community-dwelling (minimum 2 months since the last stroke)
  • having the ability to walk around the house with or without technical aids but without requiring supervision from another person (FACHS ≥ 2)
  • having enough cognitive capacity to provide informed consent and to understand and answer the questions proposed

排除标准

  • not having a strength deficit in the lower limbs or walking difficulties
  • having poor vital prognosis or suffering from other pathologies or disorders that may alter the development of the study (blindness, severe sensitivity alteration, musculoskeletal or cardiovascular conditions that contraindicate the performance of physical activity...)

结局指标

主要结局

Change from Baseline Physical activity level at a year

时间窗: 1 year

International Physical Activity Questionnaire (IPAQ)

Change from Baseline Sedentary time at a year

时间窗: 1 year

ActiGraph wGT3X-BT accelerometers

次要结局

  • Change from Baseline Bone mineral density at a year(1 year)
  • Change from Baseline Motion analysis at a year(1 year)
  • Change from Baseline Functional Mobility at a year(1 year)
  • Change from Baseline Lower extremity functioning at a year(1 year)
  • Change from Baseline Postural stability in standing at a year(1 year)
  • Change from Baseline Frailty at a year(1 year)
  • Change from Baseline Sarcopenia at a year(1 year)

研究者

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

M Luz Sanchez

PhD

University of Valencia

研究点 (4)

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