Joint PREP: Joint PRehabilitation with Exercise and Protei
Not Applicable
Completed
- Conditions
- Total hip or knee replacement surgeryMusculoskeletal Diseases
- Registration Number
- ISRCTN11121506
- Lead Sponsor
- orth Bristol NHS Trust
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37550774/ (added 09/08/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
1. Scheduled for elective primary total hip or knee replacement
2. >=12 weeks until intended date of operation
3. >=65 years of age
4. Frail according to self-report Groningen Frailty Indicator (score of >4)
Exclusion Criteria
1. Unable or unwilling to provide informed consent
2. Participating in another study that may affect the outcomes of this feasibility study or that does not permit co-enrolment in another study or where co-enrolment would be burdensome to the patient.
3. Contraindications to following trial treatments (e.g., following a low protein diet or co-morbidities which preclude participation in physical exercise)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Eligibility rate (i.e. proportion of all on list >=65 who are frail)2. Recruitment rates, calculated as the percentage of eligible patients recruited each month, as recorded in the recruitment logs at each site3. Retention rates, calculated as the number of participants who complete data collection measures and/or the intervention4. Adherence to intervention, assessed by analysis of the self-reported log on exercise and protein supplement consumption.5. Acceptability of the trial and the intervention, evaluated through qualitative semi-structured interviews with a sample of the trial participants6. Data completion rates, assessed by calculating data completeness for all measures7. Data to estimate sample size required for a definitive trial
- Secondary Outcome Measures
Name Time Method