Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Topic-guided interview of participants at discharge from hospital
研究概览
简要总结
On average, people become physically weaker during even a short stay in hospital. This study is a feasibility/pilot study to see if additional physiotherapy exercises undertaken in hospital is feasible and acceptable to patients.
The study will compare two different types of physiotherapy exercise. Both exercise programmes involve twice-daily physiotherapy provided by one of the hospital's physiotherapy assistants, but only one of the two exercise programmes expected to provide benefit. This is on top of the care that people would normally receive, and will last for the first 7 days of their hospital admission (or until they are discharged if this is earlier).
Patients will be asked to consent to the study during the first 36 hours of their hospital admission. If patients provide consent, they will undergo a baseline assessment of their functional ability (including testing of their muscle strength) before being randomly assigned to one of the two exercise programmes. The study aims to recruit 15 patients to each group (30 in total).
Once randomised patients will be seen twice a day by a physiotherapy assistant who will supervise the exercise programme.
On the day that participants are discharged (or day 7 of their admission if earlier) the assessor will repeat measures of the participants functional ability. Following these measures participants will be invited to be interviewed to discuss their experience of taking part in the study.
Approximately one month after discharge, a researcher will visit the participant to repeat measures of their functional ability at their home.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.
排除标准
- •Admitted more than 36 hours prior to recruitment; unable to provide informed consent (e.g. due to dementia, delirium, cognitive impairment); receiving end of life care or oncological treatment for diagnosed cancer; inability to cooperate in muscle strength testing (e.g. unable to sit in chair, or presence of skin integrity problems contraindicating the use of a hand-held dynamometer); transferred to or from the intensive care unit; bed-bound or requiring a hoist to transfer from bed to chair 2 weeks prior to hospitalisation; or if the Consultant in charge of the patient has any other clinical concerns regarding participation in a strengthening exercise programme.
结局指标
主要结局
Topic-guided interview of participants at discharge from hospital
时间窗: At day 7 of hospitalisation (or at discharge if earlier)
次要结局
- Barthel Index(6 weeks after discharge)
- Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention(At day 7 of hospitalisation (or at discharge if earlier))
- de Morton Mobility Index(At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge)
- Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument(6 weeks after discharge)
- Falls Efficacy Scale International(6 weeks after discharge)
- Hand held dynamometry (Knee extension + grip strength)(At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge)
- Confidence measured on a visual analogue scale(6 weeks after discharge)
- Mini-Addenbrookes Cognitive Examination(6 weeks after discharge)
- Physical activity in hospital(6 weeks after discharge)
研究者
Peter Hartley
Physiotherapist
Cambridge University Hospitals NHS Foundation Trust