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Pedaling-Based Protocol Superior to a Ten-Exercise, Non-Pedaling Protocol for Postoperative Rehabilitation Following Total Knee Replacement: A Randomized Controlled Trial.

Pedaling-Based Protocol Superior to a Ten-Exercise, Non-Pedaling Protocol for Postoperative Rehabilitation Following Total Knee Replacement: A Randomized Controlled Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000647336
Enrollment
56
Registered
2017-05-04
Start date
2017-06-06
Completion date
2017-11-21
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a research investigation into physiotherapy treatment after Total Knee Replacement surgery. This trial is specifically designed to compare two different types of physiotherapy exercise groups, to evaluate whether they provide equal benefit to patients in regards to both physical measures and patient reported satisfaction. The treatment group will be given a modified physiotherapy protocol with the main exercise being stationary pedalling, it will also include gait retraining and walking as well as a knee extension (straightening) stretch. The control group will be given a standard multi­exercise physiotherapy program which includes seated knee bends, Inner range knee strengthening exercise and functional strength exercises such as mini squats and calf raises. The control group will also be given the knee extension stretch and gait ­retraining, however, they will not be given any stationary pedalling exercises. A selection of outcome measures will be recorded at 2 days, 12 days and 4 months post-operatively in conjunction with the participant's Orthopaedic surgeon review. Outcome measures will include: Time of which the patient is deemed safe for discharge from hospital by the treating physiotherapist Timed Up & Go test functional measure test 10 Meter timed walk test 6-minute walk test Knee Range of Motion Measurement Subjective measurement tools including the EQ5D survey (incorporating a VAS pain scale), and the Oxford Knee Score. The significance of the results of this study would be to provide evidence for substituting a standard physiotherapy protocol, which includes a variety of treatment modalities and exercises, with a simplified one which can be mostly patient driven. If the results of the simplified bike pedal group are better than or no different than the standard multi­exercise physiotherapy group then there would be implications for greater time efficiency for treating physiotherapists and an overall cost benefit associated with this.

Interventions

The Intervention or "Pedalling" group will be given a modified physiotherapy protocol with the main exercise being stationary pedalling on a set of floor pedals, it will also include gait retraining and walking as well as a knee extension (straightening) stretch. A senior orthopaedic physiotherapist will be delivering both the Intervention and Control group physiotherapy protocols. In the hospital setting, the twice daily 20-minute physiotherapy session will consist of 2 exercises (pedalling and

The Intervention or "Pedalling" group will be given a modified physiotherapy protocol with the main exercise being stationary pedalling on a set of floor pedals, it will also include gait retraining and walking as well as a knee extension (straightening) stretch. A senior orthopaedic physiotherapist will be delivering both the Intervention and Control group physiotherapy protocols. In the hospital setting, the twice daily 20-minute physiotherapy session will consist of 2 exercises (pedalling and a knee extension stretch, gait retraining & aid prescription and practice of functional activities such as transfers and stair climbing. 8 minutes will be dedicated to the bike pedalling activity, 2 minutes to the extension stretch, and the other 10 minutes towards gait retraining and achievement of functional goals for discharge such as independent transfers and mobility. Once discharged the patient will continue with this home exercise program twice daily for 20 minutes and will be given a diary to tick off daily to calculate compliance, they are asked to return the diary to the assessor at their 2-week review. As patients will be independent with transfers and mobility on discharge, an increased time can be spent on their home exercise program which consists of the same exercises in hospital and should be split, 10 minutes on pedalling, 5 minutes of knee extension stretching, and 5 minutes spent on gait training with an emphasis on heel-toe strike. Both the Intervention and Control groups will commence physiotherapy on the day of surgery and undergo the same twice daily inpatient physiotherapy sessions post total knee replacement surgery, the time of each session will be approximately 20 minutes. This is no different than the standard frequency and duration of current inpatient physiotherapy sessions. Patients are instructed not to see an outpatient physiotherapist between discharge and their 2 week follow up assessment.

Sponsors

Larissa Sattler
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients of one particular Orthopaedic Surgeon at our Institution undergoing primary unilateral total knee replacement surgery with a primary diagnosis of osteoarthritis.

Exclusion criteria

Patients will be excluded if they have a history of a mental illness or a condition which would interfere with the patient’s ability to understand the requirements of the study. This may include, but is not limited to, a history of dementia or short-­term memory impairment. Participants will also be excluded if they have a predisposition to be discharged to an inpatient rehabilitation (or hostel) facility due to lack of social support (for example, the patient would otherwise return home with no carer availability) or other physical impairment that would mean they could not perform a home exercise program without “hands­on” assistance. Participants will also be excluded if they have a physical condition following surgery that makes them unable to participate in testing, i.e an extreme nauseous reaction following anaesthesia or a severe medical complication that would limit mobility such as a pulmonary embolism, or syncopal event.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026