Feasibility of Adding Early Home-based Cycling to Standard Exercises After Knee Arthroplasty: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Screening and eligibility rate
研究概览
简要总结
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.
详细描述
This pilot randomised clinical trial will evaluate the feasibility, acceptability, and safety of an early, home-based stationary cycling intervention added to standard postoperative home exercises following knee arthroplasty. The study will also evaluate the feasibility of the study procedures required for a subsequent full-scale randomised clinical trial.
A total of 24 participants will be randomised in a 1:1 ratio to either the cycling intervention group or the control group. Both groups will receive the standard postoperative home exercise programme. Participants allocated to the cycling intervention group will additionally perform the structured home-based cycling programme for eight weeks. Participants allocated to the control group will follow the standard postoperative home exercise programme without structured cycling during the intervention period. Outcome assessors conducting the 10-week follow-up assessments will be blinded to group allocation.
The pilot will address several aspects of feasibility, including screening and recruitment, retention and completion of follow-up, adherence to the allocated study intervention, acceptability of the cycling intervention, safety, and the practicality and burden of study procedures. In the control group, adherence to the instruction to refrain from cycling during the intervention period will also be assessed. The study will additionally examine the practical and logistical feasibility of delivering the cycling intervention at home, including access to stationary bikes and, where required, provision of bikes through an external rental service.
Participants will complete selected patient-reported outcome measures preoperatively and undergo a baseline assessment two weeks after surgery, before randomisation. Preoperative assessments are included for measures for which assessment two weeks after surgery is not considered appropriate or informative. Following the baseline assessment and randomisation, participants will receive the allocated intervention. The main follow-up assessment will be conducted at 10 weeks after surgery, following completion of the eight-week cycling intervention.
Recruitment feasibility will be assessed throughout the recruitment period, including screening, eligibility, recruitment rate, and reasons for declining participation. Retention will be assessed by attendance at the 10-week follow-up and completion of planned assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Early home-based stationary cycling
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.
干预措施: Early home-based stationary cycling (Other)
Usual care: home-based exercise programme
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.
干预措施: Usual care: home-based exercise programme (Other)
结局指标
主要结局
Screening and eligibility rate
时间窗: From study initiation until completion of recruitment.
The number of patients screened per week and the proportion who are eligible.
Recruitment rate
时间窗: 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
时间窗: From study initiation until completion of recruitment.
Number and proportion of eligible patients who decline participation after receiving study information.
Baseline assessment completion
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Pain sensitivity(Baseline and 10 weeks after surgery.)
- Early change in recovery(Baseline, 6 and 10 weeks after surgery.)
- Pain intensity(Pre-operatively, at baseline, and at 6 and 10 weeks and 6 and 12 months postoperatively.)
- Pain distribution(Pre-operatively, at 10 weeks and 6 and 12 months after surgery.)
- Pain medication use(Pre-operatively, at baseline, and at 6 and 10 weeks and 6 and 12 months after surgery.)
- Knee range of motion(Baseline and 10 weeks after surgery.)
- Knee range of motion(Pre-operatively, 6 weeks, 6 months, and 12 months after surgery.)
- Knee swelling(Baseline and 10 weeks after surgery.)
- 40-metre fast-paced walk test(Baseline and 10 weeks after surgery.)
- 30-second chair stand test(10 weeks after surgery.)
- Stair climb test(10 weeks after surgery.)
- Physical activity level(Pre-operatively, and at 10 weeks, 6 months, and 12 months after surgery.)
- Objective physical activity(During the final week of the 8-week intervention period.)
- Patient satisfaction and perceived outcome(10 weeks, and 6 and 12 months after surgery.)
研究者
Mette Garval
Physiotherapist, PhD student
Central Jutland Regional Hospital