Novel pre-surgery exercise in patients waiting for a total knee replacement
| ISRCTN | ISRCTN75779521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75779521 |
| IRAS number | 198930 |
| ClinicalTrials.gov number | NCT03113032 |
| Secondary identifying numbers | IRAS198930 |
- Submission date
- 01/05/2017
- Registration date
- 03/05/2017
- Last edited
- 08/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff. Total knee replacement (TKR), which involves replacing the knee with an artificial joint, is the treatment of choice for patients suffering from long-standing severe pain, functional limitation and instability caused by osteoarthritis of the knee joint. Knee joint instability causes a feeling of ‘unsteadiness’ whilst walking and may also contribute to falls. In view of the latter, it is important for this issue of ‘unsteadiness’ to be addressed. TKR helps to remove the cause of pain and swelling, but exercises are crucial to counteract the joint’s instability and any feeling of ‘unsteadiness’ before and after surgery. However, research hasn’t yet found the best approach for delivering exercises to help with patients’ rehabilitation. Current studies have tried to incorporate rehabilitation programmes to improve this issue, but required a delivery of 6-8 weeks of exercises which has resulted in a logistical burden due to the long duration. A new programme of exercise has been developed for the muscles of the knee that can be delivered during a single week before surgery. The pre-surgery exercise programme (P-SEC) potentially offers similar effectiveness for improving the feeling of ‘unsteadiness’ and muscle fitness as programmes that last much longer. Therefore, the aim of this study is to test the effectiveness of this new, short approach to exercising in patients who are waiting for TKR surgery.
Who can participate?
Patients over the age of 18 with severe osteoarthritis and awaiting TKR
What does the study involve?
Participants are randomly allocated into three groups. The first group carry out the exercise programme using the leg awaiting surgery. The second group carry out the exercise programme using the opposite leg. The third group do not carry out the exercise programme. During the exercise programme participants are asked to perform a set of 36 short exercises across three alternate days. The exercises are performed on a seated knee extensor machine. The participants are asked to lift the foot bar with both legs, lowering the allocated leg and catching the weight with that same leg. This movement is repeated at different weights across the three alternate days with appropriate recovery time in between each exercise. The participants’ knees are assessed at the start of the study, 2 weeks before surgery (before the exercise programme), 1 week before surgery (at the end of the exercise programme), on the day of surgery and 6 weeks after surgery.
What are the possible benefits and risks of participating?
The intensity and extent of the tests required for this study are no more than what patients would experience during normal rehabilitation sessions. In addition, the exercises proposed in this study are tailored to the participant’s physical abilities and are pain free. Thus, the risks to patients taking part in this study are no more than those of normal clinical practice and daily activities. The assessments and exercises are carried out by a qualified, experienced physiotherapist who works with members of the medical team to ensure safety and care of the participant during the study.
Where is the study run from?
Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2017 to May 2018
Who is funding the study?
Endeavour Scholarship Scheme Malta, European Social Funds 2020
Who is the main contact?
Ms Anna Maria Risso
Contact information
Scientific
31/3 Arden Street
Edinburgh
EH9 1BS
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Novel Pre-Surgery Exercise-Conditioning (P-SEC) in patients waiting for a Total Knee Arthroplasty (TKA): a randomised controlled trial |
| Study acronym | P-SEC |
| Study objectives | What is the efficacy of a pre-surgery exercise conditioning (P-SEC) programme for motor performance of the surgical leg in eliciting significant gains in functional, sensorimotor, neuromuscular and psychophysiological performance capabilities in patients awaiting TKA? The effectiveness of the P-SEC conditioning will be gauged against local contemporary practice (no conditioning), against relative gains in performance associated with P-SEC of the non-surgical leg and against perseverance of beneficial effects following TKA surgery. |
| Ethics approval(s) | South East Scotland Research Ethics Committee Local 01, 08/03/2017, ref: 17/SS/0005 |
| Health condition(s) or problem(s) studied | Patients with severe osteoarthritis of the knee awaiting a Total Knee Replacement (TKR) |
| Intervention | The patients will be block randomised into three groups by a member of the medical team at RJAH NHS Trust Foundation. The list of patients allocated to which group will be kept by the same medical team member in a safe allocated area and will only be given to the chief investigator towards the end of the trial to allow for appropriate blinding. 1. Experimental group 1 will receive the P-SEC intervention on the leg awaiting surgery (surgical leg) 2. Experimental group 2 will receive the P-SEC intervention on the opposite leg (non-surgical leg) 3. Control group - no intervention will be applied to either of the patient's legs The P-SEC intervention is an exercise-based intervention, where patients in the experimental groups, will be asked to perform a set of 36 short/brief exercises across 3 alternate days. The exercises are performed on a seated knee extensor machine. The patients will be asked to lift the foot bar (set at appropriate weight intensities according to the protocol) with both legs, lowering the experimental leg and catching the weight with that same leg. This movement is repeated at different weight intensities across the 3 alternate days with appropriate recovery time in between each exercise. There are five data assessment points: baseline, 2-weeks prior to surgery (prior to the P-SEC intervention in the experimental groups), 1 week prior to surgery (at the end of the P-SEC intervention in the experimental groups), on the day of surgery and 6 weeks post-surgery. |
| Intervention type | Behavioural |
| Primary outcome measure | Electromechanical Delay (EMD) of the knee extensor musculature. The data obtained will give an indication of the participants' sensorimotor and neuromuscular performance capacities. Measurements of the latter's activity will be obtained from electromechanical signals collected by a purpose-built dynamometer (Gleeson et al. 2013) and EMG signals obtained from surface electrodes over the knee extensor musculature. Both the primary and secondary outcome measures will be taken at five data assessment points: baseline, 2-weeks prior to surgery (prior to the P-SEC intervention in the experimental groups), 1 week prior to surgery (at the end of the P-SEC intervention in the experimental groups), on the day of surgery and 6 weeks post-surgery. |
| Secondary outcome measures | 1. Sensorimotor and neuromuscular performance capacities through balance force plate, peak force (PF), rate of force development (RFD) and H-Reflex using data obtained from the EMG and seated dynamometer used for the primary outcome measurement 2. Patients’ perceived performance capacities in function and pain, measured through various subjective questionnaires such as: 2.1. Knee Injury and Osteoarthritis Outcome Score (KOOS) 2.2. Oxford Knee Score (OKS) 2.3. Category-Ratio Scale (CR-10) Performance profile 2.4. SF-36v2 2.5. Pain Self Efficacy questionnaire 2.6. Physical activity questionnaire (IPAQ) Both the primary and secondary outcome measures will be taken at five data assessment points: baseline, 2 weeks prior to surgery (prior to the P-SEC intervention in the experimental groups), 1 week prior to surgery (at the end of the P-SEC intervention in the experimental groups), on the day of surgery and 6 weeks post-surgery. |
| Overall study start date | 22/03/2017 |
| Completion date | 06/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 29 |
| Key inclusion criteria | 1. Males and females over the age of 18 2. Diagnosed with severe osteoarthritis (OA) 3. Awaiting primary TKA (Including contralateral knee OA/TKA and/or other orthopaedic conditions affecting the contralateral leg) |
| Key exclusion criteria | 1. Individuals electing primary knee arthroplasty surgery due to a knee joint disease other than osteoarthritis - rheumatic disorder 2. Other orthopaedic conditions affecting lower body function 3. Neurological disorders 4. Individuals with reduced mental capacity affecting their ability to follow exercise programme |
| Date of first enrolment | 15/05/2017 |
| Date of final enrolment | 23/01/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SY10 7AG
United Kingdom
Sponsor information
University/education
Queen Margaret University Drive
Musselburgh
Edinburgh
EH21 6UU
Scotland
United Kingdom
| Website | http://www.qmu.ac.uk |
|---|---|
"ROR" |
https://ror.org/002g3cb31 |
Hospital/treatment centre
Gobowen
Oswestry
Gobowen
SY10 7AG
England
United Kingdom
| Website | http://www.rjah.nhs.uk |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 27/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The results from the RCT will be published through appropriate scientific journals and presented at relevant conferences following analysis of the full dataset obtained at the end of the trial. The protocol of the trial will be published in scientific journals and presented at local and international conferences during the duration of the trial and following its completion. 2018 results in thesis https://core.ac.uk/display/222840839?source=3 |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/06/2022 | 08/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/06/2022: Publication reference and total final enrolment added.
27/07/2020: Thesis added to publication and dissemination plan.
05/04/2019: Internal review.
24/05/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2018 to 23/01/2018.
2. The overall trial end date was changed from 15/05/2018 to 06/04/2018.
