Early home-based cycling after knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial will add an eight-week, home-based stationary cycling program to standard postoperative home exercises for people recovering from knee arthroplasty. The study will assess feasibility, safety, and acceptability of the cycling intervention, as well as procedures needed for a larger trial. Participants will be randomized to either usual care or usual care plus the cycling program, with outcome assessors blinded to group. Feasibility outcomes include recruitment, adherence, retention, and the practicality of delivering the cycling intervention. The trial aims to inform design and logistics for a subsequent larger study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Ability to use a smartphone with internet connectivity (required for completion of electronic questionnaires and using SENS motion application) or a tablet and having an email address enabling completion of electronic questionnaires.

Exclusion Criteria:

* 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).
* Active cancer treatment, if this treatment would interfere with safe participation or adherence to the cycling protocol.
* Preoperative reduced knee flexion preventing full pedal rotation on a stationary bike.
* Current or recent history of alcohol and/or substance misuse, as identified during the anaesthetic pre-assessment and documented in the electronic patient record.
* Cognitive impairment (e.g. dementia) or diagnosed psychiatric disorder that would prevent the patient from understanding or adhering to the cycling protocol.

Where it's running

• Regional Hospital Silkeborg
  Silkeborg, Central Jutland, Denmark Recruiting

Study contacts

• Principal investigator: Mette Garval, MSc — University Clinic for Orthopaedic Pathways (UCOP), Elective Surgery Centre, Regional Hospital Silkeborg, Regional Hospital Central Jutland, Denmark
• Study coordinator: Mette Garval, MSc
• Email: metgar@rm.dk
• Phone: +45 29773935

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.