Feasibility of an Early Home-based Cycling Intervention After Knee Arthroplasty
NCT ID
NCT07838012
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Central Jutland Regional Hospital
Conditions
Knee Arthroplasty, Knee Osteoarthritis
Overview
ClinicalTrials.gov lists this study as Recruiting.
Official title: Feasibility of Adding Early Home-based Cycling to Standard Exercises After Knee Arthroplasty: A Pilot Randomised Controlled Trial
Enrollment: 24 participants (Estimated).
What is being studied
Other: Early home-based stationary cycling
Other: Usual care: home-based exercise programme
Who may be eligible
Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No
ClinicalTrials.gov lists the following eligibility criteria.
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.
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Trial information can change. Confirm current study details with the study team or the registry.
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