ISRCTN13927531
Completed
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Enrollment
- 743
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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