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Osteo Arthritis KneeP-SECNCT03113032

Novel Pre-Surgery Exercise-Conditioning in Patients Waiting for Total Knee Arthroplasty (TKA)

A study testing P-SEC Pre-Surgical Care and Normal pre-surgical care in people with Osteo Arthritis Knee, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Total knee replacement (TKR) is the treatment of choice for patients suffering from long standing severe pain, functional limitation and instability caused by osteoarthritis (OA) of the knee joint's surfaces. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
P-SEC Pre-Surgical Care and Normal pre-surgical care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited Kingdom
Study dates
15 May 2017to 17 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and Females over the age of 18, diagnosed with severe osteoarthritis (OA) of the knee and awaiting a TKA (Including contralateral knee OA/TKA and/or other orthopaedic conditions affecting the contralateral leg)

Who cannot join

  • Individuals undertaking TKA due to a knee joint disease other than osteoarthritis
  • Rheumatic disorder
  • Neurological disorders
  • Other orthopaedic conditions affecting lower body function
  • Individuals with reduced mental capacity affecting their ability to follow exercise programme

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Robert Jones and Agnes Hunt NHS Trust Foundation

    Oswestry, Gobowen, SY10 7AG

Other trials in United Kingdom

About this study

Total knee replacement (TKR) is the treatment of choice for patients suffering from long standing severe pain, functional limitation and instability caused by osteoarthritis (OA) of the knee joint's surfaces. Long standing arthritic joint surfaces, more often lead to pain and swelling and other physical factors that may contribute to knee joint instability. This 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' instability and any feeling of 'unsteadiness' before and after surgery. However, research hasn't yet identified the optimum approach for delivering exercises that will help in 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 in view of the long duration. We have scientifically developed a new programme of exercise for the muscles of the knee that can be delivered during a single week prior to 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 purpose of this research study is to test the effectiveness of this new, short approach to exercising in patients who are waiting for a TKR surgery.

Read the detailed description

Total knee arthroplasty (TKA) is the treatment of choice for patients suffering from severe pain and functional limitation caused by osteoarthritis (OA) of the knee joint's surfaces (Magee et al. 2009). Within the UK, over 60,000 TKA surgeries are registered yearly (NJR 2015), making TKA one of the most common surgeries of the joint. Rehabilitation following surgery is essential for recovery and with TKA this is crucial in regaining movement, function and control. Current rehabilitation mainly focuses on post-surgery rehabilitation to increase range of motion (ROM) and muscle power, and to aid in achieving a quick return to functional independence for patients. Despite this, research has shown that patients undergoing TKA, still continue to experience reduced capacities in neuromuscular responses which are required for quick knee joint reactions, stability and proprioception, up to months following TKA surgery (Silva et al. 2003). A deficit in an individual's knee joint proprioception (synonymously referred to as a deficit in sensorimotor performance), together with impaired strength, can lead to reduced functional balance capabilities and movement control (Piva et al. 2010; Rätsepsoo et al. 2011), and can also contribute to injury (Lephart et al. 1997) and a greater risk of falls (Swinkels et al. 2009; Bade et al. 2010; Rätsepsoo et al. 2011). In part, the latter may be due to time-constraints within the health-care system, where a necessary preservation of the primary focus, to decrease pain and improve general function in patients following a TKA, has sometimes been to the detriment of other aspects of rehabilitation.

Pre-surgery exercise-conditioning:

Studies have investigated the effects of pre-surgery exercise' (also known as pre-habilitation exercise) interventions on strength and sensorimotor performance deficits in patients undergoing TKA, through various modes of exercise. Their aim has been to utilise a period of time pre-surgery to improve patients' rehabilitation status (Huber et al. 2015; Topp et al. 2009; Desmueles et al. 2013; Mackay et al. 2012). However, the patterns of patients' adaptations to the generic exercise stimuli used within these studies, has not shown the gains that had been expected by physiological dose-response, and ultimately questioned the efficacy of using pre-habilitation for effective gains in long-term outcomes. Nevertheless, the concept of achieving early gains to conditioning status that might potentiate patients' later rehabilitation processes and status, remains attractive to the latter (Calatayud et al. 2016, Huber et al. 2015) and the NHS (Rooks et al. 2006; Crowe and Henderson, 2003).

Conditioning for enhanced sensorimotor performance has been consistently endorsed in the sports-medical and sports-performance (Hubscher et al. 2010; Mandelbaum et al. 2005) and clinical literature (Tsao et al. 2007; Granacher et al. 2006) for its causal relationship to reduced injury likelihood and capability to improve function. While the precise dose of stimuli to achieve gains in sensorimotor performance is less clearly defined, enhancing motor performance by means of exercise that resist the effects of gravity or externally-applied loading to a joint system, has established underpinnings physiologically by improving motor performance and indirectly effecting sensorimotor responses (Vikne et al. 2006; Hakan et al. 2002; Moran et al. 2007). Clinically, the challenge has been to formulate a suitably pragmatic programme of conditioning that will accommodate the time- and cost-pressures associated with contemporary care practice while simultaneously offering efficacy when delivered prior to surgery as a pre-habilitative intervention. Rehabilitative and prophylactic conditioning programmes used in current studies for enhanced neuromuscular and sensorimotor performance, have typically required and been delivered in a duration of 6-8-weeks (Calatayud et al. 2016; Huber et al. 2015; Topp et al. 2009; Desmueles et al. 2013; Mackay et al. 2012). This has commanded a substantive logistical burden to elicit expected gains.

A novel approach to conditioning - Development of the P-SEC protocol:

A novel formulation of conditioning that could condense the pattern of delivery of physiologically-effective, dose-related stimuli, while simultaneously maintaining the vast proportion of potential gains in performance, would offer advantages to patients and clinicians for logistical versatility with which a package of conditioning might be delivered. This would be especially important within the relatively short period of time between the patients electing for surgery after clinical consultation and a surgical procedure, if pre-habilitation were to be incorporated effectively within care pathways. Recent studies have shown that with careful periodization and micro-cyclical management of the mode of exercise-conditioning, patterning of exercise intensity and work/recovery ratios, and progression of increasing physiological stimuli for adaptation, it is possible to deliver gains in neuromuscular performance within a programme lasting 2-3-weeks, which match 70% of the effects expected during longer programmes (Peer and Gleeson, in press; Peer et al. under review). Additional adaptations to this intervention model would be needed to counteract arthrogenic and autogenic sources of inhibition associated with long-term disease conditions such as OA (Rice et al. 2010), limiting neuromuscular performance and conditioning gains by the intrusion of nociceptive stimuli such as an increase in intra-articular joint pressure (Palmieri-Smith et al. 2007). The cost-neutrality of the embedding pre-habilitative conditioning for improved motor performance might be feasible if a portion of the end-phase rehabilitation following a surgical procedure, which has been shown recently to offer limited gains in performance within the formal care pathway (Bailey et al. 2014), could be sacrificed in favour of an equivalent time- period of conditioning prior to surgery.

Therefore, the purpose of the P-SEC study is to undertake a randomized controlled feasibility trial in order to investigate the effects of this new formulation of exercise-conditioning for motor performance on objectively-measured and patient-perceived sensorimotor, functional and psychophysiological performance capacities in patients waiting for a TKA.

Being tested
P-SEC Pre-Surgical Care, Normal pre-surgical care
Keywords
total knee replacement, sensorimotor training, pre-surgery exercise, sensorimotor function, neuromuscular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-SEC Pre-Surgical CareOther

    The P-SEC protocol is designed to deliver a focal mode of exercise-conditioning for motor performance to the knee extensor musculature. The latter requires a brief, machine-based gravity-resisted joint' movements (<2 seconds). An exercise session (6-minutes, approximately) will require a patient to undertake 4 sets of movement, with sets separated by 60-seconds recovery (delivering a total of 36 exercises across 3 interspersed days).

  • Normal pre-surgical careOther

    Routine pre-surgical care

Study groups in NCT03113032
Study groupRoleWhat they receive
Exercise group 1ExperimentalThis group of patients will receive the P-SEC exercise intervention protocol on their 'surgical' leg in addition to their normal pre-surgical care.
Receives: Other: P-SEC Pre-Surgical Care
Exercise group 2ExperimentalThis group of patients will receive the P-SEC exercise intervention protocol on their 'non-surgical' leg in addition to their normal pre-surgical care.
Receives: Other: P-SEC Pre-Surgical Care
Control groupActive comparatorThis group of patients will not receive the P-SEC protocol but will follow normal pre-surgical care along with the other two groups of patients.
Receives: Other: Normal pre-surgical care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electromechanical delay (EMD)

    The primary outcome measure for this study is the measurement of 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.

    Measured: 11 months

Secondary outcomes (9)
  1. Balance Force plate

    Measurement of postural control indices through the use of a standing balance force plate

    Measured: 11 months

  2. Peak Force (PF)

    Further measurements of Sensorimotor and Neuromuscular performance capacities using data obtained from the EMG and seated dynamometer used for the primary outcome measurement.

    Measured: 11 months

  3. Rate of force Development (RFD)

    Further measurements of Sensorimotor and Neuromuscular performance capacities using data obtained from the EMG and seated dynamometer used for the primary outcome measurement.

    Measured: 11 months

  4. Knee Injury and Osteoarthritis questionnaire (KOOS) questionnaire

    Subjective measurement of patients' performance capacity

    Measured: 11 months

  5. Oxford Knee score (OKS)

    Subjective measurement of patients' performance capacity

    Measured: 11 months

  6. Performance profile questionnaire

    Subjective measurement of patients' performance capacity

    Measured: 11 months

  7. Pain self efficacy questionnaire

    Subjective measurement of patients' performance capacity

    Measured: 11 months

  8. Short Form Health Questionnaire (SF36v2)

    Subjective measurement of patients' performance capacity

    Measured: 11 months

  9. International Physical Activity Questionnaire (IPAQ)

    Subjective measurement of patients' performance capacity

    Measured: 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start15 May 2017
  3. Primary completion17 Apr 2018
  4. Study completion17 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised Controlled Feasibility Study
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03113032
Sponsor's protocol ID
P-SEC001
Acronym
P-SEC
Status last verified
Jun 2017
First submitted
4 Apr 2017
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Risso AM, van der Linden ML, Bailey A, Gallacher P, Gleeson N. Exploratory insights into novel prehabilitative neuromuscular exercise-conditioning in total knee arthroplasty. BMC Musculoskelet Disord. 2022 Jun 7;23(1):547. doi: 10.1186/s12891-022-05444-0.

    PubMed 35672761

Questions about this trial

What is this clinical trial studying?

A study testing P-SEC Pre-Surgical Care and Normal pre-surgical care in people with Osteo Arthritis Knee, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electromechanical delay (EMD) (time frame: 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03113032, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.

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