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临床试验/NCT07374159
NCT07374159已完成不适用

Severe Mental Disorders, Chronicity and Sedentary Behaviour: Usability and Effectiveness of the "Sit Less, Move More" Program as an Integrated Service at Osonament

Fundació Universitària del Bages1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2018年2月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
Physical activity levels

研究概览

简要总结

People with severe mental illness (SMI), such as schizophrenia, bipolar disorder, or major depressive disorder, experience a life expectancy reduction of 10-20 years, largely due to chronic conditions like cardiovascular disease and type 2 diabetes. These individuals are less physically active and spend more time in sedentary behaviours (SB), which are associated with increased mortality, poor metabolic health, worse cognition, and lower quality of life. Traditional studies often rely on self-reported SB, which is unreliable, whereas objective measures like accelerometry provide more accurate data. Understanding SB patterns is essential for designing effective interventions to reduce prolonged sitting and improve health outcomes in this population.

This study aimed to describe daily SB patterns in outpatients with SMI and evaluate the feasibility of the "Sit Less, Move More" program integrated into routine care at Osonament, a community mental health center in Catalonia. The pragmatic intervention lasted 16 weeks and included two weekly contacts: face-to-face sessions for planning walking routes and strategies to increase activity, and telephone follow-ups to reinforce goals. Participants were grouped by affinity and residence to encourage autonomous walks, and the program was embedded within individual recovery plans. Ethical approval was obtained, and informed consent was secured.

Sedentary behaviour and physical activity were measured using the ActivPAL™ accelerometer, worn continuously for seven days at baseline and post-intervention. The device provided detailed data on sitting time, standing, light activity, and moderate-to-vigorous activity, as well as SB bouts categorized by duration. Self-perceived health was assessed using a visual analogue scale. From 412 potential candidates, 231 were invited, 60 enrolled, and 53 completed the program. Dropouts were due to psychiatric relapse, hospitalization, discharge, relocation, or loss of interest.

The study demonstrates the feasibility of integrating SB reduction strategies into community mental health services and highlights the importance of objective SB measurement. It provides a foundation for developing tailored interventions that break up prolonged sitting and promote movement among people with SMI, addressing a critical gap in improving physical health and reducing premature mortality in this vulnerable population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, 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

  • Being an active user of Osonament
  • Having a clinical diagnosis of a severe mental illness (e.g., schizophrenia, bipolar disorder, etc) in a stable plhase of the illness

排除标准

  • Actively using toxics substances
  • Had a predominant diagnosis other than a sever mental disorder
  • Presented with medical contraindication that prevented safe participation in physical activity

研究组 & 干预措施

Intervention

Experimental

干预措施: Sit less and move more (Behavioral)

Comparator

Active Comparator

干预措施: Actual care (Other)

结局指标

主要结局

Physical activity levels

时间窗: From enrollment to the end of intervention at 12 weeks

Total physical activity levels will be measured though accelerometry using ActivPAL. Total levels of physical activity (light or moderate-high) will be recorded in minutes

Sedentary behaviour

时间窗: From enrollment to the end of intervention at 12 weeks

Patterns of sedentary behvaiour will be measured though accelerometry using ActivPAL. Patterns of sedentary behaviour will be recorded in minutes and bouts

Self-perceived health

时间窗: From enrollment to th end of intervention at 12 weeks

Self-perceived health was evaluated using a single-item visual analogue scale ranging from 0 to 100, where participants rated their general health status, with higher scores indicating better perceived health. This measure was chosen for its simplicity and feasibility in populations with severe mental disorders.

次要结局

未报告次要终点

研究者

发起方
Fundació Universitària del Bages
申办方类型
Other
责任方
Sponsor

研究点 (1)

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