Feasibility of an Early Home-based Cycling Intervention After Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Jutland Regional Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for unilateral primary medial unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA).
Age ≥ 18 years.
Able to speak and read Danish.
Daily access to a stationary bike during the intervention period, or willingness to use a stationary bike provided by the study through an external rental company for the duration of the intervention. Due to logistical constraints, loan bikes can only be provided to participants residing within approximately one hour of transport from Aarhus or Silkeborg. Participants living outside this area may participate if they have access to a stationary bike.
Disqualifiers
Previous surgery in either lower limb within 3 months before the date of knee arthroplasty or planned surgery in either lower limb within 3 months after the date of knee arthroplasty.
Inflammatory joint disease
Previous osteotomy around the knee or tibial condyle fracture that has been treated with osteosynthesis in the affected knee.
Medical or physical conditions that would prevent safe participation in the cycling intervention (e.g., unstable cardiovascular, pulmonary, or chronic neurodegenerative disorders).
Trial design
Design model
Parallel
Treatments tested in this trial
Early home-based stationary cycling
Other interventionParticipants 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
Other interventionParticipants 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Early home-based stationary cyclingExperimental treatment 1 intervention
Group B: Usual care: home-based exercise programmeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Screening and eligibility rate
The number of patients screened per week and the proportion who are eligible.
Time frame
From study initiation until completion of recruitment.2
Recruitment rate
Number of eligible patients providing verbal agreement to participate per week and proportion of eligible patients providing verbal agreement to participate.
Time frame
From study initiation until completion of recruitment.3
Declined participation among eligible patients
Number and proportion of eligible patients who decline participation after receiving study information.
Time frame
From study initiation until completion of recruitment.4
Baseline assessment completion
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.
Time frame
At baseline, before randomisationSecondary outcomes
1
Knee-related pain, symptoms, function and quality of life
Knee-related pain, symptoms, function in activities of daily living, and knee-related quality of life assessed using four subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS): Pain, Symptoms, Activities of Daily Living, and Quality of Life. Each subscale is scored from 0 to 100, with higher scores indicating better outcomes. The KOOS4 is calculated from these four subscales. The individual four KOOS subscale scores will also be reported.
Time frame
Pre-operatively, 10 weeks, 6 months, and 12 months after surgery.2
Health-related quality of life
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Each of the five dimensions is scored from 1 to 5, with higher scores indicating greater severity of problems. The five dimensions assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Self-rated health will also be assessed using the EQ visual analogue scale (EQ VAS), scored from 0 to 100, with higher scores indicating better self-rated health.
Time frame
Pre-operatively, 10 weeks, 6 months, and 12 months after surgery.3
Mental well-being
Mental well-being assessed using the World Health Organization-Five Well-Being Index (WHO-5). The raw score ranges from 0-25, with higher scores indicating better mental health. The raw score will be transformed to a percentage score from 0-100, with higher scores indicating better mental well-being.
Time frame
Pre-operatively, 10 weeks, 6 months, and 12 months after surgery.4
Early recovery
Patient-reported early postoperative recovery assessed using the Oxford Arthroplasty Early Recovery Score (OARS). The overall 14-item OARS is scored from 0 to 100, with higher scores indicating better recovery.
Time frame
Baseline, 6 and 10 weeks after surgery.Other outcomes
1
Practicality and feasibility of study procedures
Practicality and feasibility of conducting baseline and follow-up assessments, delivering the home-based cycling intervention, using the SENS Motion® sensor system, and providing stationary bikes through an external rental service. Practical challenges related to study procedures and equipment will be documented through participant feedback, free-text questionnaire comments, project staff observations and feedback, and regular project team meetings.
Time frame
From study initiation to 10 weeks after surgery.2
Need for supervised rehabilitation
Need for supervised rehabilitation will be recorded from baseline to the 10-week follow-up. All participants will be assessed at 10 weeks to determine whether supervised rehabilitation is clinically indicated.
Time frame
From baseline to 10 weeks after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Central Jutland Regional Hospital
Lead sponsor
Aalborg University
Collaborator
Source ClinicalTrials.gov