跳至主要内容
临床试验/NCT04134871
NCT04134871已完成不适用

Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness

University of Ulster3 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2019年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
3
主要终点
Study recruitment rate

研究概览

简要总结

People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active.

A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them.

The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Inactive adults (Male or Female; aged ≥18 years)
  • Diagnosis of any SMI (schizophrenia, psychosis, bipolar disorder and major depression).

排除标准

  • Significant movement impairment
  • Identified as 'Active' using the GPPAQ screening tool
  • Unable to understand English or lack comprehension to understand the purpose of the study and given written informed consent.

结局指标

主要结局

Study recruitment rate

时间窗: Through study completion, approx. 18 months

The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.

Retention of study participants

时间窗: Through study completion, approx. 18 months

The number of participants that complete the study intervention versus the number of dropouts will be analysed along with reasons for drop out.

Level of acceptability assessed by semi-structured interviews

时间窗: Data will be collected from participants at completion of the intervention, approx 3 months.

Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention

次要结局

  • Change in activity levels(Data will be collected at baseline and at completion of intervention, approx 3 months.)
  • Change in body weight (kilograms)(Data will be collected at baseline and at completion of intervention, approx 3 months.)
  • Change in waist circumference (cm)(Data will be collected at baseline and at completion of intervention, approx 3 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验