Joint PREP: Joint PRehabilitation with Exercise and Protein
| ISRCTN | ISRCTN11121506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11121506 |
| IRAS number | 312883 |
| Secondary identifying numbers | CPMS 53511, Grant Codes: NIHR202289, IRAS 312883 |
- Submission date
- 22/09/2022
- Registration date
- 29/09/2022
- Last edited
- 26/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
One-third to one-half of people waiting for hip/knee replacements are frail (which generally means they have poor strength and function) or are at risk of becoming frail (‘pre-frail’) and may not recover as well after surgery as those who are not. They may experience more complications and longer hospital stay. Studies have looked at ways to help people to prepare before their surgery, to increase their chances of an easier recovery. An improved diet with extra protein and pre-operative exercise may lead to fewer post-operative complications and faster recovery. However, few studies have included frail people, and none have looked at pre-operative protein and exercise in this group waiting for hip or knee replacement in the NHS. A large study is required to see if frail patients undergoing hip or knee replacements, have improved outcomes if they consume more protein and exercise daily in the weeks leading up to their operation. First, we want to see if people are willing to do this by running a small study. If they are, we will design a larger study to test whether this can improve recovery from surgery.
Who can participate?
Frail patients who are aged 65 years or older, scheduled for total hip or knee replacement surgery with at least 12 weeks until their intended date of operation.
What does the study involve?
Participants will be randomised to one of two groups using a computer-based tool. One group will follow usual care and will not receive any additional advice or treatment to that provided routinely by the NHS. The other group will be given a daily protein supplement to add to their diet and will be asked to follow a home-based, tailored daily exercise programme for up to 12-weeks before their operation.
All participants will complete questionnaires about health and quality of life soon after recruitment to the trial and at 12 weeks (or just before surgery).
What are the possible benefits and risks of participating?
We do not know if increasing protein intake and exercise in the weeks leading up to joint replacement surgery will help improve recovery in frail patients. Although participants may not receive any measurable benefit from taking part in this trial, research like this helps to continually improve the care and treatments provided to all patients now and in the future. There are only minimal risks involved in this research. Potential side effects of exercise include a temporary ache in muscles and joints, similar to that commonly experienced after unaccustomed exercise. However, these effects are normally mild and will resolve themselves following a short period of rest. Participants in the intervention arm will be given a tailored exercise program based on their individual ability and will be carefully trained on how to perform and progress the exercises to minimise these risks. They will also be encouraged to take adequate rest periods in between to prevent aggravating symptoms.
Where is the study run from?
North Bristol NHS trust (UK)
When is the study starting and how long is it expected to run for?
January 2022 to December 2023
Who is funding the study?
NIHR Research for Patient Benefit Programme (UK)
Who is the main contact?
Dr Tanzeela Khalid, t.khalid@bristol.ac.uk
Contact information
Scientific
Musculoskeletal Research Unit
Transational Health Sciences
Bristol Medical School
University of Bristol
Level 1 Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0003-3503-7762 |
|---|---|
| Phone | +44 117 455 1561 |
| t.khalid@bristol.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A randomised controlled feasibility trial of a prehabilitation intervention in frail older people undergoing total hip or knee replacement |
| Study acronym | Joint PREP |
| Study objectives | Pre-operative exercise and protein supplements may lead to fewer post-operative complications and faster recovery in frail individuals undergoing total hip or knee replacement. However, it is not known whether it is possible to recruit people scheduled for total joint replacement surgery in the NHS at the right time to allow for successful implementation of the planned intervention, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a daily program of exercise and protein supplementation in the 12 weeks prior to surgery in frail individuals undergoing total hip or knee replacement in the NHS. |
| Ethics approval(s) | Approved 30/08/2022, East of Scotland Research Ethics Service (Ninewells Hospital & Medical School, Tayside Medical Science Centre (TASC), Residency Block, Level 3, George Pirie Way, Dundee, DD1 9SY, UK; +44 (0)1382 383871; tay.eosres@nhs.scot), ref: 22/ES/0033 |
| Health condition(s) or problem(s) studied | Total hip or knee replacement surgery |
| Intervention | 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 supplement to add to their diet and will be asked to follow a home-based, tailored daily exercise programme for up to 12-weeks before their operation. All exercises will be demonstrated by a physiotherapist either in-person at a hospital appointment, online or using a hybrid model. Appropriate starting levels will be based on individual physical capacity and risk assessment, and participants will be supported to gradually increase their levels of moderate physical activity throughout the weeks leading up to their surgery through regular telephone/videocalls from a physiotherapist. Usual care group: Participants will receive usual care for the duration of the study. |
| Intervention type | Mixed |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/01/2022 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 64 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 21/11/2022 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Llandough
Penarth
CF64 2XX
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 117 414 9330 |
|---|---|
| ResearchSponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Open access publication in a peer-reviewed journal, final report to funder, presentations at scientific conferences, plain language summaries of findings for participants and the public. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Anonymised data will be stored indefinitely on the University of Bristol’s secure online Research Data Storage Facility. In accordance with the University’s policy for sharing of anonymised research data, participants will be asked for their consent to make the anonymised data available to other researchers for whom this data may help facilitate the answering of their research question. Data will only be accessible to members of the study research team but may also be made available to other research teams who request the data to answer their own research questions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 07/08/2023 | 09/08/2023 | Yes | No | |
| Results article | 17/09/2024 | 26/09/2024 | Yes | No |
Editorial Notes
26/09/2024: Publication reference added.
09/07/2024: The intention to publish date was changed from 01/07/2024 to 01/10/2024.
08/12/2023: The total final enrolment was added.
09/08/2023: Publication reference added.
11/07/2023: The recruitment end date was changed from 31/07/2023 to 31/08/2023.
13/03/2023: The following changes have been made:
1. The recruitment end date has been changed from 01/05/2023 to 31/07/2023.
2. The trial website has been added.
3. The secondary outcome measures have been changed and the plain English summary updated accordingly.
08/12/2022: Walsgrave General Hospital was removed and University Hospital Llandough and Princess Elizabeth Orthopaedic Centre were added as trial participating centres.
07/11/2022: The recruitment end date has been changed from 01/11/2022 to 21/11/2022.
17/10/2022: The recruitment end date has been changed from 01/10/2022 to 01/11/2022.
22/09/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
