Feasibility of an Early Home-based Cycling Intervention After Knee Arthroplasty

Condition(s) studied

Investigational drug(s) / intervention(s)

Early home-based stationary cycling: Participants will receive individual instruction in the cycling protocol from a physiotherapist in addition to the standard postoperative home-based exercise programme described for the control group. Beginning two weeks after knee arthroplasty, participants will perform 30 minutes of home-based stationary cycling at least five days per week for eight weeks. Cycling will initially be performed at a comfortable pace with no resistance and a cadence of approximately 50-60 rpm, with cadence and resistance gradually increasing as tolerated. If unable to complete full pedal rotations, participants will perform pendulum exercises twice daily for five minutes until sufficient knee flexion is achieved. A traffic-light symptom guide will be used to adjust cycling according to pain and swelling. Participants will not be routinely referred to supervised rehabilitation during the intervention period but may contact the physiotherapy team for advice or attend a consultation if clinically indicated.

Usual care: home-based exercise programme: Participants will follow the standard post-operative home-based exercise programme, consisting of five exercises targeting knee range of motion and quadriceps strength, performed twice daily. At the two-week post-operative follow-up, participants will receive instruction in a second exercise programme. The exercises prescribed will be individually adjusted by a physiotherapist according to the participant's recovery and readiness for progression, including knee range of motion, functional capacity, and pain. Participants will not be routinely referred to supervised rehabilitation during the intervention period but may contact the physiotherapy team for advice or attend an additional consultation if clinically indicated.

Study summary

The goal of this pilot clinical trial is to evaluate whether an early, home-based stationary cycling programme, provided in addition to standard postoperative home exercises, is feasible and acceptable for patients recovering from knee arthroplasty. It will also inform the design of a larger clinical trial examining the effects of adding early cycling to standard postoperative home exercises on postoperative outcomes.

The main questions it aims to answer are:

* Can the cycling programme and planned study procedures be delivered as intended?
* Are participants willing and able to take part in the study and follow the planned interventions?
* Do participants find the cycling programme and outcome assessments acceptable?
* What changes, if any, are needed before conducting a larger clinical trial?

Researchers will compare an early home-based stationary cycling programme provided in addition to standard postoperative home exercises with standard postoperative home exercises alone.

Participants will:

* Be randomly assigned to either the cycling group or the standard exercise group (control group) two weeks after surgery.
* If assigned to the cycling group, perform 30 minutes of stationary cycling at home at least five days per week for eight weeks in addition to the standard postoperative home exercise programme.
* If assigned to the control group, follow the standard postoperative home exercise programme and refrain from structured cycling during the eight-week intervention period.
* Complete questionnaires and physical assessments at baseline and follow-up visits.
* Complete selected patient-reported outcome measures at 6 and 12 months after surgery.

Eligibility

Primary outcome measure(s)

• Screening and eligibility rate — From study initiation until completion of recruitment.
  The number of patients screened per week and the proportion who are eligible.
• Recruitment rate — From study initiation until completion of recruitment.
  Number of eligible patients providing verbal agreement to participate per week and proportion of eligible patients providing verbal agreement to participate.
• Declined participation among eligible patients — From study initiation until completion of recruitment.
  Number and proportion of eligible patients who decline participation after receiving study information.
• Baseline assessment completion — At baseline, before randomisation
  Proportion of participants who provide written informed consent and complete the planned baseline assessment before randomisation. Completion of individual objective and physical performance assessments will also be recorded to identify any assessments that are not completed.
• Retention and completion of 10-week follow-up assessments — 10 weeks after surgery
  Proportion of randomised participants who attend the 10-week follow-up assessment and proportion who complete all planned objective and physical performance assessments, reported separately for the intervention and control groups. Reasons for non-attendance and incomplete assessments will also be recorded.
• Adherence to the cycling intervention — 2 to 10 weeks after surgery.
  Objective adherence to the prescribed cycling intervention, including frequency and duration of cycling sessions and the proportion of prescribed cycling days completed, assessed using the SENS Motion® sensor system.
• Cycling-related pain, swelling and discomfort — Approximately 1-2 weeks after initiation of the cycling intervention.
  Participant-reported pain, swelling and discomfort related to cycling, assessed during a structured telephone assessment approximately one week after initiation of the cycling intervention. Responses will be recorded descriptively. Participants unable to complete full pedal rotations will be contacted again one week later.
• Acceptability of the cycling intervention — 10 weeks after surgery.
  Participant-reported acceptability of the home-based cycling intervention assessed using selected items from the Theoretical Framework of Acceptability (TFA) questionnaire. The items assess affective attitude, burden, perceived effectiveness, self-efficacy, and overall acceptability. Responses are recorded on five-point Likert scales.
• Completion of patient-reported outcome measures — Baseline and 10 weeks after surgery
  Proportion of participants who complete all planned patient-reported outcome measures (PROMs) at baseline and 10-week follow-up. Completion of individual PROMs and missing questionnaire items will also be recorded to identify PROMs with incomplete data.
• Participant-reported burden of outcome assessments — Baseline and 10 weeks after surgery
  Participant-reported burden of the questionnaires and objective assessments, assessed using two yes/no questions on whether the assessments were so burdensome that the participant would choose not to participate in a similar study again. Participants answering "yes" will be asked to provide a brief reason.
• Adverse events and postoperative complications — From randomisation to 10 weeks after surgery.
  Adverse events and postoperative complications reported by participants or identified in electronic health records during the study period. Events will be recorded and summarised descriptively.

Trial sites (1)

More Central Jutland Regional Hospital trials in Denmark

Other trials for the same condition