Effect of Preoperative Training and Education on Pre- and Postoperative Functional Performance in Patients Awaiting TKA; A Randomized Controlled Trial - a Pilot Study
Effect of Preoperative Training and Education on Pre- and Postoperative Functional Performance in Patients Awaiting TKA; A Randomized Controlled Trial - a Pilot Study
The objectives of this study are to investigate the feasibility primarily and furthermore the effects of a four to eight-weeks program of a combined clinic- and home-based preoperative physical therapy (exercise training and education) versus usual care in patients awaiting unilateral primary TKA up to 3 months after surgery.
The patients randomized into the intervention group are going to pass through a three-week therapy program. This program is based on MD's prescription and provides 9 sessions of physical therapy per prescription. All patients carry out their therapy at University Center for Prevention and Sports Medicine (UCePS) Balgrist. Before the evaluation phase starts, each patient is introduced by a member of the research team and gets a written information sheet about the goal of the study and the following procedure. The patients have to signature an informed consent to their participation in our investigation. Both groups are to be tested four times: The first assessment is appointed at a minimum of four weeks before surgery. Their baseline characteristics are noted, knee ROM, SCT, TUG, 5STS, 2MWT, handgrip strength and pain score are assessed and they need to fill in the KOOS, the Short Form 12 (SF-12) and the Tegner Activity Scale. After the first assessment, the Intervention Group (IG) is allowed to start the physical therapy exercise and education intervention. Each Physical Therapist treating a participant was previously introduced to the study protocol and the intended intervention. They conduct a total of 9 sessions over a 4 to 8-weeks period before surgery with one to two appointments per week. The Control Group (CG) is asked to keep its activity level as it is before the baseline measure. It is not desired, that anyone in this group starts a new type of therapy or training in preoperative stage. Patients in both groups keep their diary about changes concerning pain, medicament intake, training and therapies during the full length of intervention and follow-up phase.
One monitoring visit at the investigator's site prior to the start, one visit within one year after inclusion of the first participant and approximately once visit per annum during the course of the study will be organised by the Sponsor. Furthermore, there will be a monitoring visit at the study end. During the monitoring, all documents including source data/documents will be accessible for the monitor and all questions will be answered. Data will be entered in REDCap and retrieved from the clinic's information system.
If a subject is withdrawn, all previous collected data will be used for the final evaluation. All collected data will be used. An intention to treat analysis will be performed.
Data Handling and Record Keeping / Archiving:
Data management:
Reporting of Serious Adverse Events (SAE):
Clinical investigators and ultimately the Principal Investigator (PI) have the primary responsibility for SAE identification, documentation, grading, and assignment of attribution to the intervention under study. Clinical study participants will be routinely questioned about Adverse Events (AE) at study visits. The well-being of the participants will be ascertained by neutral questioning ("How are you?"). Observed or volunteered SAE, regardless of treatment group or suspected causal relationship to the study treatment(s) will be recorded in the patient file and subsequently in the electronic CRF (eCRF) if a relationship to the study intervention cannot be excluded. All SAEs in which a relation to the study intervention cannot be excluded, will be fully documented in the appropriate eCRF. For each such SAE, the investigator will provide the onset, duration, intensity, treatment required, outcome and action taken with the investigational device or study related procedure.The investigator shall report these events: a.) to the sponsor within 24 hours after they become known; and b.) to the responsible ethics committee via Business Administration System for Ethic Committees (BASEC) within 15 days.
Inclusion Criteria:
Exclusion Criteria: