Individually randomised controlled multi-centre trial to determine the clinical and cost effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation

Bradford Teaching Hospitals NHS Foundation Trust0 个研究点目标入组 743 人开始时间: 2017年4月19日最近更新: 2024年6月18日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34749783/ (added 23/08/2022) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38783180/ A secondary analysis of the embedded process evaluation (added 04/06/2024)

•1. Age 65 years and over
•2. Admitted to elderly medicine / trauma & orthopaedics wards following acute illness or injury then discharged home from hospital or from intermediate care
•3. Frailty, identified using a score of 5-7 on the 9-item Clinical Frailty Scale (CFS)
•4. Mobility, identified by ability to complete the TUGT without additional external support (other than usual walking aids)
•5. Willing and able to give informed consent to participate in the study or consultee declaration where the patient lacks capacity
•6. Able to communicate by telephone (to support intervention delivery, and follow-up assessments - dependent upon allocation and method of completion)

•1. Permanent care home residents (but not those occupying temporary rehabilitation beds within a care home as part of intermediate care services)
•2. Moderate/severe dementia at baseline* (defined as Montreal Cognitive Assessment test < 20)
•3. Severe, disabling stroke at baseline* (defined as new or previous stroke with Barthel Index < 9)
•4. Recent (< 3 months prior randomisation) myocardial infarction, or unstable angina
•5. Another household member in the study
•6. Very severe frailty (defined as score of 8 on CFS)
•7. Terminally ill (defined as score of 9 on CFS)
•8. Receiving palliative care
•9. Referral at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation)
•10. Currently participating in HERO or another contraindicated study

发起方