Efficacy of a Nurse-developed Physical and Cognitive Program to Improve Sleep and Quality of Life in Elderly: Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Sleep
研究概览
简要总结
The present clinical trial aims to test whether a dual program of physical activity and cognitive training improves sleep and quality of life in people over 65 years of age.
详细描述
The intervention is being carried out in different day centers and co-housing centers in Toledo, Spain, where participants were recruited. A three-arm study was also conducted: a control group that received talks on health topics; a physical activity intervention group that followed the Otago physical activity program, tailored to; and a physical activity and cognitive training intervention group that used a mobile app known as Cognifit to develop the cognitive intervention.
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 (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •know how to use smartphones.
- •have the ability to perform physical activity.
排除标准
- •be under 65 years of age.
- •suffer from serious pathologies that prevent the intervention from being carried out.
研究组 & 干预措施
Control
Talks are given on health education topics that are not related to the intervention to the participants.
干预措施: Control (Behavioral)
Otago programme
a physical activity intervention is applied to the participants.
干预措施: Otago programme (Behavioral)
Otago programme + Cognitift
a physical activity and cognitive training intervention is applied to the participants.
干预措施: Otago programme + Cognifit (Behavioral)
结局指标
主要结局
Sleep
时间窗: Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).
Latency, sleep efficiency, number of awakenings during the night will be measured by actigraphy. The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to asees objetive sleep quality and patterns in adults. It consists of 19 self-reported items. The 9 self-reported items of the PSQI generate seven component scores (with subscales ranging from 0 to 3): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. The sum of these seven component scores produces an overall subjective sleep quality score (ranging from 0 to 21). Higher scores indicate poorer subjective sleep quality.
次要结局
- Quality of life in older people(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
- Cognitive assessment and training(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
- Sociodemographic variables(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
- Level of social support and social network of older adults(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
- Depression(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
- Mobility(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.)
- Memory(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.)
- Cognitive disorders(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2, 8 weeks after the end of the intervention.)
- Degree of independence of older people in performing Basic Activities of Daily Living (BADLs)(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
- Functional capacity in Instrumental Activities of Daily Living(Pre intervention T0 (one week before intervention started), post intervention T1 (after 12 weeks of intervention) and follow up T2 (8 weeks after the end of the intervention).)
研究者
Laura Pilar de Paz Montón
Predoctoral researcher
University of Castilla-La Mancha