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临床试验/NCT04079439
NCT04079439终止不适用

Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability (PA-IDe Study): a Randomised Controlled Trial

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
60
试验地点
2
主要终点
Steps per day

研究概览

简要总结

The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.

详细描述

Individuals with intellectual disability (ID) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. As increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. E-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with ID.

The purpose of this study is to examine the effectiveness of an individually tailored PA programme with motivational mobile e-health support on everyday level of PA in youths and adults with ID.

The PA-IDE trial uses a prospective randomized controlled design. In total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. The intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. The intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. Participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). All participants will be assessed at baseline, 3-, and 6 months. Participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the Goal Attainment Scaling (GAS) will be used. Primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. Secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a PA setting, behaviour problems, and goal attainment.

The investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. Technology offers new opportunities to influence healthy behaviours. The trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with ID.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Intellectual disability
  • Age 15-60 years
  • Low physical activity
  • Sedentary lifestyle

排除标准

  • Medical contradictions for participation
  • High levels of physical activity

结局指标

主要结局

Steps per day

时间窗: Baseline, 3 months and 6 months

The primary outcome is physical activity, objectively assessed by steps per day measured with an accelerometer. This will objectively assess physical activity and sedentary time. Change in steps per day is being assessed at baseline, after three months of intervention and after 6 months of intervention.

次要结局

  • Waist Circumference(Baseline, 3 months and 6 months)
  • Goalsetting(Baseline, 3 months and 6 months)
  • Physical activity(Baseline, 3 months and 6 months)
  • Challenging behaviour(Baseline, 3 months and 6 months)
  • Social network(Baseline, 3 months and 6 months)
  • Blood pressure(Baseline, 3 months and 6 months)
  • Physical functioning(Baseline, 3 months and 6 months)
  • Body Mass Index (BMI)(Baseline, 3 months and 6 months)
  • Satisfaction with life(Baseline, 3 months and 6 months)
  • Self-efficacy and social support(Baseline, 3 months and 6 months)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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