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

NCT07838012 | Recruiting

• 4 other identifiers: 654615A4560R248-A9052R251-A9053
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis; Knee Arthroplasty

Keywords

Knee arthroplasty; Postoperative rehabilitation; Home-based rehabilitation; Stationary cycling; Feasibility study; Postoperative recovery

Outcome Measures

Primary Outcomes (11)

• Screening and eligibility rate

  The number of patients screened per week and the proportion who are eligible.

  From study initiation until completion of recruitment.

• Recruitment rate

  Number of eligible patients providing verbal agreement to participate per week and proportion of eligible patients providing verbal agreement to participate.

  From study initiation until completion of recruitment.

• Declined participation among eligible patients

  Number and proportion of eligible patients who decline participation after receiving study information.

  From study initiation until completion of recruitment.

• 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.

  At baseline, before randomisation

• Retention and completion of 10-week follow-up assessments

  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.

  10 weeks after surgery

• Adherence to the cycling intervention

  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.

  2 to 10 weeks after surgery.

• Cycling-related pain, swelling and discomfort

  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.

  Approximately 1-2 weeks after initiation of the cycling intervention.

• Acceptability of the cycling intervention

  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.

  10 weeks after surgery.

• Completion of patient-reported outcome measures

  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.

  Baseline and 10 weeks after surgery

• Participant-reported burden of outcome assessments

  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.

  Baseline and 10 weeks after surgery

• Adverse events and postoperative complications

  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.

  From randomisation to 10 weeks after surgery.

Secondary Outcomes (18)

• Knee-related pain, symptoms, function and quality of life

  Pre-operatively, 10 weeks, 6 months, and 12 months after surgery.

• Health-related quality of life

  Pre-operatively, 10 weeks, 6 months, and 12 months after surgery.

• Mental well-being

  Pre-operatively, 10 weeks, 6 months, and 12 months after surgery.

• Early recovery

  Baseline, 6 and 10 weeks after surgery.

• Early change in recovery

  Baseline, 6 and 10 weeks after surgery.

Other Outcomes (2)

• Practicality and feasibility of study procedures

  From study initiation to 10 weeks after surgery.

• Need for supervised rehabilitation

  From baseline to 10 weeks after surgery.

Study Arms (2)

Early home-based stationary cycling

EXPERIMENTAL

Participants will begin a home-based stationary cycling programme two weeks after knee arthroplasty. They will perform 30 minutes of stationary cycling at least five days per week for eight weeks, in addition to the standard postoperative home-based exercise programme.

Other: Early home-based stationary cycling

Usual care: home-based exercise programme

ACTIVE COMPARATOR

Participants will follow the standard postoperative home-based exercise programme beginning two weeks after knee arthroplasty. The programme focuses on knee mobility and muscle activation and does not include the stationary cycling intervention.

Other: Usual care: home-based exercise programme

Interventions

Early home-based stationary cycling OTHER

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.

Early home-based stationary cycling

Usual care: home-based exercise programme OTHER

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.

Usual care: home-based exercise programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Regional Hospital Silkeborg

Silkeborg, Central Jutland, 8600, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David H Christiansen, Professor

  University Clinic for Orthopaedic Pathways (UCOP), Elective Surgery Centre, Regional Hospital Silkeborg, Regional Hospital Central Jutland, Denmark

  STUDY CHAIR

• Mette Garval, MSc

  University Clinic for Orthopaedic Pathways (UCOP), Elective Surgery Centre, Regional Hospital Silkeborg, Regional Hospital Central Jutland, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Garval, MSc

CONTACT

+45 29773935; metgar@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and physiotherapists delivering the intervention cannot be masked to group allocation due to the nature of the intervention. Outcome assessors conducting the 10-week follow-up assessments will be masked to group allocation. Baseline assessments are conducted before randomisation. Patient-reported outcome measures are self-completed by participants, reducing the potential influence of outcome assessors.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD student

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups, with randomisation stratified by type of knee arthroplasty (unicompartmental knee arthroplasty \[UKA\] or total knee arthroplasty \[TKA\]). The cycling intervention group will receive an eight-week home-based stationary cycling programme in addition to standard post-operative home exercises. The control group will receive standard postoperative home exercises alone and will be asked to refrain from cycling during the eight-week intervention period.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 24, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)