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

NCT03113032 | Completed DMC

• 1 other identifier: P-SEC001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteo Arthritis Knee

Keywords

total knee replacement; sensorimotor training; pre-surgery exercise; sensorimotor function; neuromuscular

Outcome Measures

Primary Outcomes (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.

  11 months

Secondary Outcomes (9)

• Balance Force plate

  11 months

• Peak Force (PF)

  11 months

• Rate of force Development (RFD)

  11 months

• Knee Injury and Osteoarthritis questionnaire (KOOS) questionnaire

  11 months

• Oxford Knee score (OKS)

  11 months

Study Arms (3)

Exercise group 1

EXPERIMENTAL

This group of patients will receive the P-SEC exercise intervention protocol on their 'surgical' leg in addition to their normal pre-surgical care.

Other: P-SEC Pre-Surgical Care

Exercise group 2

EXPERIMENTAL

This group of patients will receive the P-SEC exercise intervention protocol on their 'non-surgical' leg in addition to their normal pre-surgical care.

Other: P-SEC Pre-Surgical Care

Control group

ACTIVE COMPARATOR

This 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.

Other: Normal pre-surgical care

Interventions

P-SEC Pre-Surgical Care OTHER

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).

Exercise group 1; Exercise group 2

Normal pre-surgical care OTHER

Routine pre-surgical care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead
• Queen Margaret University: collaborator

Study Sites (1)

Robert Jones and Agnes Hunt NHS Trust Foundation

Oswestry, Gobowen, SY10 7AG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35672761 DERIVED

Study Officials

• Nigel Gleeson, Prof.

  Queen Margaret University

  STUDY DIRECTOR

• Anna Maria Risso, Ms

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The chief investigator who will deliver the exercise protocol will be blinded as to which leg is the intended leg for surgery. This will be done by another member of the medical team allocating the patients in block randomisation as they come in from the waiting list. This list with the respective "surgical" leg will be kept safely away from the chief investigator until all data is recorded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Feasibility Study

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 13, 2017
• Study Start: May 15, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: March 10, 2020

Record last verified: 2017-06

Locations

GB (1)