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临床试验/ACTRN12620000189921
ACTRN12620000189921已完成未知

ENAbLE- Pilot. Secondary prevention of stroke. A physical activity and diet pilot randomised controlled trial

niversity of Newcastle0 个研究点目标入组 40 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

We assessed whether telehealth-delivered physical activity and/or diet interventions are feasible and safe for people with stroke or TIA, and reduce stroke risk factors. Physical inactivity and poor diet quality are significant risk factors for stroke. International guidelines recommend increasing physical activity and improving diet quality to reduce the risk of recurrent stroke. There is however little evidence to support this. 40 stroke survivors who had experienced a stroke or TIA took part. • The telehealth-delivered interventions were found to be safe and feasible. Attendance at intervention sessions was high, with minimal dropout rates. There were no serious adverse events related to the interventions. • Participants receiving the physical activity intervention reported spending significantly more time being physically active compared to those who did not receive the intervention. • Participants who received the diet intervention showed promising improvement in overall diet quality. They also reported improvements in quality of life. • There were trends toward lower blood pressure associated with both the physical activity and diet interventions. Limitations The study faced difficulties reaching the target sample size, possibly impacted by the COVID-19 pandemic. Study participants were predominantly young, lived in metropolitan areas, had normal blood pressure, and felt confident in their ability to exercise and results may not be generalisable to other populations.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • (i)Aged over 18 years
  • (ii)Self-reported stroke or TIA between 3 months to 10 years ago
  • (iii)Living at home
  • (iv)Able to walk independently at least short distances, based on participant self-report.
  • (v)Sufficient cognitive ability and/or carer support to engage in the interventions
  • (vi)Access to stable internet connection which can adequately support telehealth service

排除标准

  • (i)Living in residential care
  • (ii)Unstable cardiac conditions, severe arthritis or other conditions limiting the ability to exercise
  • (iii)Food allergies limiting the ability to adhere to the AusMed diet
  • (iv)Difficulties swallowing (dysphagia)
  • (v)Already meeting physical activity guidelines (score =moderate” International Physical Activity Questionnaire
  • (vi)Already adhering to a Mediterranean-style diet, indicated by a Mediterranean Diet Score Survey
  • (vii)Enrolled in another physical activity or diet intervention trial.

研究者

发起方
niversity of Newcastle

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