Total hip or knee replacement surgery Musculoskeletal Diseases
Conditions
Interventions
Patients who are =65 years of age and frail will be randomised on a 1:1 allocation to either the Joint PREP intervention or usual care.
Intervention group: Participants will be given a daily protein
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 site 3. Retention rates, calculated as the number of participants who complete data collection measures and/or the intervention 4. 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 participants 6. Data completion rates, assessed by calculating data completeness for all measures 7. Data to estimate sample size required for a definitive trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/03/2023: 1. Frailty measures determined from use of the Groningen Frailty Index and Clinical Frailty Scale at the screening stage and during the pre-operative assessment 2. Protein adequacy of usual diet measured using Protein screener 55+ during screening stage 3. Usual physical activity levels measured using the Global Physical Activity Questionnaire at baseline and at the end of the intervention period 4. Patient reported outcomes (including WOMAC, EQ-5D-5L, and ICECAP-O). These will all be measured at baseline and pre-operatively. 5. Operative and post-operative data (e.g., length of hospital stay, complications, mobilisation and physiotherapy protocol). This data will be collected from patient notes or medical records when the patient is 1-2 months post-operative. 6. Qualitative assessment of the acceptability of the study. _____ Previous secondary outcome measures: 1. Frailty measures determined from use of the Groningen Frailty Index and Clinical Frailty Scale at the screening stage and during the pre-operative assessment 2. Protein adequacy of usual diet measured using Protein screener 55+ during screening stage. 3. Usual physical activity levels measured using the Global Physical Activity Questionnaire at baseline and at the end of the intervention period. 4. Patient reported outcomes (including WOMAC, EQ-5D-5L, and ICECAP-O). These will all be measured at baseline, pre-operatively and 12 weeks post-operatively. 5. Operative and post-operative data (e.g., length of hospital stay, complications, mobilisation and physiotherapy protocol). This data will be collected from patient notes or medical records when the patient is 1-2 months post-operative. 6. Complications, readmissions, primary care contacts, and physiotherapy appointments attended to week 12 post-operation collected on the post-operative questionnaire. | — |
Countries
England, United Kingdom
Outcome results
None listed