跳至主要内容
临床试验/NCT05027620
NCT05027620已完成不适用

Continued Support for Physical Activity in Everyday Life With Parkinson's Disease Using eHealth Technology

Stiftelsen Stockholms Sjukhem2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年10月5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
15
试验地点
2
主要终点
Participants perceived intensity of the motor exercises

研究概览

简要总结

The purpose of this study is to test the feasibility of a novel motor-cognitive home training intervention using eHealth technology among people with Parkinson's Disease

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Neurologist diagnosed Idiopathic PD at least 6 months previous to inclusion.
  • Hoehn & Yahr stages I-III
  • Stable in anti-Parkinson medications three months prior to inclusion.
  • The ability to walk walk independently indoors without a walking aid.
  • The ability to walk continually with/without a walking aid for at least 5 minutes.

排除标准

  • Cognitive impairment affecting the ability to understand or follow verbal or written instructions (Montreal Cognitive Assessment ≤ 21 points).
  • Impaired vision and/or impaired communication which hinders participation.
  • Major problems with freezing and/or two or more falls in the month previous to inclusion.
  • Other existing neurological/ orthopedic or cardiovascular disease which impedes the performance of unsupervised exercise in the home.
  • No internet connection in the home.

结局指标

主要结局

Participants perceived intensity of the motor exercises

时间窗: 10-week period.

Participants will rate the intensity of the intervention using the Borg Rating of perceived, Exertion Scale (6-20) following each training session. According to this scale, lower numbers signify lower levels of exertion, and higher numbers signify higher levels of exertion. The aim is that participants levels of exertion will lie in the middle range (12-17) This will measure the feasibility outcome - Practicality or Ability to carry out the intervention.

Participants actual use of the eHealth training tool

时间窗: 10-week period.

Total time logged in to the digital training app will be derived from system and expressed as a percentage of total recommended intervention time. This will measure the feasibility outcome - Demand of the intervention'.

Participant satisfaction with the eHealth intervention

时间窗: 10-week period.

Participants will rate their satisfaction with using a digital survey following each training session. An average value will be calculated. This will measure the feasibility outcome - Acceptability of the intervention.

Participants perceived difficulty of the motor-cognitive (dual-task) exercises

时间窗: 10-week period.

Participants will rate the difficulty of the dual-task exercises using a 0-10 scale (higher scores = higher degree of difficulty) following each exercise session and scores will be averaged over the study period following. This will measure the feasibility outcome - Suitability of the intervention.

Total number of adverse events during the training sessions

时间窗: 10 week period

Participants will report all adverse events such as falls or other injuries acquired during the training session, during a once weekly telephone interview. This will measure the feasibility outcome Safety.

次要结局

  • Exercise self-efficacy(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Lower extremity function(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Executive Function(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Functional capacity as well as dual task gait ability(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Self-reported walk ability(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Usual and fast walking speed(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Balance performance(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Self-reported difficulties across 8 dimensions of daily living(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Habitual physical activity(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Self-reported balance confidence(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))
  • Verbal Fluency(i) Baseline, pre-intervention. ii) Immediately after the intervention (10-week home training))

研究者

发起方
Stiftelsen Stockholms Sjukhem
申办方类型
Other
责任方
Principal Investigator
主要研究者

Breiffni Leavy

Principal Investigator

Stiftelsen Stockholms Sjukhem

研究点 (2)

Loading locations...

相似试验