Clinical trial NCT05314985: Prehab Intervention in Patients Awaiting Total Knee Arthroplasty (TKA)
Official title: Effect of Preoperative Training and Education on Pre- and Postoperative Functional Performance in Patients Awaiting TKA; A Randomized Controlled Trial - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Preoperative Exercise
Physical Therapy Modalities
Arthroplasty, Replacement, Knee
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2022-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* Case Report Forms (CRF): For each enrolled study participant, a printed CRF is maintained. Appropriate coded identification is used: Initials followed by birth year. CRF data is entered into an electronic database for analysis (double data entry).
* Specification of Source Documents: Source data is available at the site to document the existence of the study participants. Source includes the original documents relating to the study, as well as medical history of the participant. Source documents in this study are CRF, hardcopy of printed hearing thresholds (audiograms), informed consent forms and patient list. All hardcopies are collected in a file folder and stored in a lockable cabinet in the office of the PI.
* Record Keeping / Archiving: All study data is archived for a minimum of 10 years after study termination or premature termination of the clinical trial. All hardcopies are collected in a file folder and stored in a lockable cabinet in the office of the PI.

Data management:

* Data Management System: Data is entered in REDCap® electronic data capture system, provided by the University Hospital Balgrist.
* Data Security, Access and Back-up: Data is saved on the personal account. Backup system is in place and hosted by the IT department of the University Hospital Balgrist.
* Analysis and Archiving: Data is entered into an electronic database for analysis (SPSS).
* Electronic and Central Data Validation: All data collected for this research project will be registered in encrypted form in an automatic secure online processing (REDCap® electronic data capture system). Data entry is performed exclusively by authorized persons involved in the research project. Data processing and storage also takes place in REDCap®. Only encrypted data will be used for data analysis and statistical evaluation.

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.

Eligibility criteria: Inclusion Criteria:

* Adult male and female participants (≥18 years)
* Patients receiving a unilateral TKA
* Signed informed consent after being informed

Exclusion Criteria:

* BMI \>35
* Patella alta (Caton Deschamps Index \>1.2)
* Muscle weakness due to neurological diagnosis
* Known or suspected non-compliance
* Known depression or other psychiatric disorders
* Acute pain exacerbations or inflammation
* Patellar instability
* Contradictions on ethical grounds
* Non-German speaking

Primary outcomes:
measure: Preoperative functional performance compared to baseline
timeFrame: 2-10 days before sugery
Secondary outcomes:
measure: Preoperative functional performance compared to usual care
timeFrame: 2-10 days before sugery
measure: Preoperative stair climbing before TKA compared to baseline
timeFrame: 2-10 days before sugery
measure: Preoperative stair climbing before TKA compared to usual care
timeFrame: 2-10 days before sugery
measure: Preoperative walking performance before TKA compared to baseline
timeFrame: 2-10 days before sugery
measure: Preoperative walking performance before TKA compared to usual care
timeFrame: 2-10 days before sugery
measure: Preoperative strength before TKA compared to baseline
timeFrame: 2-10 days before sugery
measure: Preoperative strength before TKA compared to usual care
timeFrame: 2-10 days before sugery
measure: Preoperative activity level before TKA compared to baseline
timeFrame: 2-10 days before surgery
measure: Preoperative activity level beforeTKA compared to usual care
timeFrame: 2-10 days before surgery
measure: Preoperative level of pain compared to baseline
timeFrame: 2-10 days before sugery
measure: Preoperative level of pain compared to usual care
timeFrame: 2-10 days before sugery
measure: Preoperative quality of life compared to baseline
timeFrame: 2-10 days before sugery
measure: Preoperative quality of life compared to usual care
timeFrame: 2-10 days before sugery
measure: Preoperative knee joint mobility compared to baseline
timeFrame: 2-10 days before surgery
measure: Preoperative knee joint mobility compared to usual care
timeFrame: 2-10 days before surgery
measure: Postoperative functional performance 6 weeks after TKA compared to baseline
timeFrame: 6 weeks postoperative
measure: Postoperative functional performance 6 weeks after TKA compared to usual care
timeFrame: 6 weeks postoperative
measure: Postoperative activity level 6 weeks after TKA compared to baseline
timeFrame: 6 weeks postoperative
measure: Postoperative activity level 6 weeks after TKA compared to usual care
timeFrame: 6 weeks postoperative
measure: Postoperative level of pain 6 weeks after TKA compared to usual care
timeFrame: 6 weeks postoperative
measure: Postoperative level of pain 6 weeks after TKA compared to baseline
timeFrame: 6 weeks postoperative
measure: Feasibility of prehabilitation program: Number of participants with adherence to the therapy sessions of at least 80%
timeFrame: 6 weeks postoperative
measure: Dischargeability: Length of Stay in hospital (LoS)
timeFrame: 6 weeks postoperative
measure: Postoperative functional performance 3 months after TKA compared to baseline
timeFrame: 3 months postoperative
measure: Postoperative functional performance 3 months after TKA compared to usual care
timeFrame: 3 months postoperative
measure: Postoperative stair climbing 3 months after TKA compared to baseline
timeFrame: 3 months after sugery
measure: Postoperative stair climbing 3 months after TKA compared to usual care
timeFrame: 3 months after sugery
measure: Postoperative walking performance 3 months after TKA compared to baseline
timeFrame: 3 months after surgery
measure: Postoperative walking performance 3 months after TKA compared to usual care
timeFrame: 3 months after surgery
measure: Postoperative strength 3 months after TKA compared to baseline
timeFrame: 3 months after sugery
measure: Postoperative strength 3 months after TKA compared to usual care
timeFrame: 3 months after sugery
measure: Postoperative activity level 3 months after TKA compared to baseline
timeFrame: 3 months postoperative
measure: Postoperative activity level 3 months after TKA compared to usual care
timeFrame: 3 months postoperative
measure: Postoperative level of pain 3 months after TKA compared to baseline
timeFrame: 3 months postoperative
measure: Postoperative level of pain 3 months after TKA compared to usual care
timeFrame: 3 months postoperative
measure: Postoperative quality of life 3 months after TKA compared to baseline
timeFrame: 3 months postoperative
measure: Postoperative quality of life 3 months after TKA compared to usual care
timeFrame: 3 months postoperative
measure: Postoperative knee joint mobility 3 months after TKA compared to baseline
timeFrame: 3 months after surgery
measure: Postoperative knee joint mobility 3 months after TKA compared to usual care
timeFrame: 3 months after surgery
measure: Postoperative Global Impression of Change compared to usual care
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Johannes Scherr, Prof.
role: PRINCIPAL_INVESTIGATOR
References: