The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Physical function
研究概览
简要总结
This study aims to examine 1) if multicomponent exercise interventions (including both mobility and strengthening exercises) have effects on physical function compared to usual care in older adults, and 2) if a comprehensive multicomponent exercise program is more effective than a simple multicomponent exercise program including only walking and rising from a chair.
详细描述
This is a three-armed randomized controlled trial, with two intervention groups (comprehensive and simple exercise program) and a control group receiving usual care. Participants aged ≥75 years will be included consecutively from geriatric medical wards of hospitals in Stockholm, Sweden. Assessments will be conducted at hospital admission, discharge and three months thereafter concerning physical function (primary outcome), activities of daily living, health-related quality of life, sarcopenia, and falls. Number of re-admissions and mortality will be registered up to 1 year after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to stand up from a sitting position independently or with minimal personal help
- •ability to communicate and collaborate with the research staff
排除标准
- •people who are not able to follow instructions
- •people who by the responsible physician are assessed as not eligible to participate due to terminal illness or any major medical condition that contraindicates exercise
- •those living in nursing home
- •those previously included in the study
研究组 & 干预措施
Intervention 1 (simple exercise program)
The intervention will include up to four sessions per day. It consists of sit-to stand exercises and walking along the corridor of the ward (for those who can walk).
干预措施: Intervention 1 (simple exercise program) (Other)
Intervention 2 (comprehensive exercise program)
This intervention consists of two daily sessions (morning and afternoon). The morning session includes individualized supervised progressive resistance, balance, and walking training exercises, tailored to each participant's capacity. The resistance training includes using weight cuffs, involving mainly lower-extremity muscles. Balance and gait exercises includes different exercises such as line walking, stepping practice, and walking with small obstacles. The evening session consists of functional exercises using light loads, such as knee extension and flexion, hand training with a ball, and daily walking exercises (for those who can walk).
干预措施: Intervention 2 (comprehensive exercise program) (Other)
Control group
The control group will receive usual care, which may include physical rehabilitation when needed.
结局指标
主要结局
Physical function
时间窗: Change from baseline (hospital admission) to 3 months after discharge
Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)
Physical function
时间窗: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)
次要结局
- Sarcopenia(Change from baseline (hospital admission) to 3 months after discharge)
- Activities of daily living(Change from baseline (hospital admission) to 3 months after discharge)
- Health related quality of life(Change from baseline (hospital admission) to 3 months after discharge)
- Mortality data(Up to 1 year after hospital discharge)
- Number of falls(From hospital discharge to 3 months after discharge)
- Number of readmissions(Up to 1 year after hospital discharge)
- Activities of daily living(Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline))
- Health related quality of life(Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline))
- Sarcopenia(Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline))
- Number of falls(Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline))
研究者
Anna-Karin Welmer
Associate professor
Karolinska Institutet