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Clinical Trials/ISRCTN13927531
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

Bradford Teaching Hospitals NHS Foundation Trust0 sites743 target enrollmentApril 19, 2017

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)

Registry
who.int
Start Date
April 19, 2017
End Date
May 31, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

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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