Osteoarthritis, KneeNCT05314985
Prehab Intervention in Patients Awaiting Total Knee Arthroplasty (TKA)
A study testing Prehab intervention in people with Osteoarthritis, Knee, run by Balgrist University Hospital at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Prehab intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Apr 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female participants (≥18 years)
- Patients receiving a unilateral TKA
- Signed informed consent after being informed
Who cannot join
- 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
Show all 9Show fewer
- Patellar instability
- Contradictions on ethical grounds
- Non-German speaking
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Prehab intervention
- Keywords
- Preoperative Exercise, Physical Therapy Modalities, Arthroplasty, Replacement, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehab interventionOther
Individual training program containing strengthening, sensori-motor, joint mobilisation and endurance exercises as well as educational inputs concerning perioperative procedure and instructions on e.g. how to walk with crutches.
| Study group | Role | What they receive |
|---|---|---|
| Prehab Group / Intervention Group | Experimental | 4 to 8 weeks of preoperative physical therapy training and education intervention before total knee replacement surgery. Receives: Other: Prehab intervention |
| Control Group | No intervention | Usual care / no treatment before total knee replacement surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative functional performance compared to baseline
To compare functional performance immediately pre-surgery after preoperative physical therapy in patients awaiting a TKA to baseline.
Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
Measured: 2-10 days before sugery
Secondary outcomes (40)
Preoperative functional performance compared to usual care
To compare functional performance immediately pre-surgery after preoperative physical therapy to patients with usual care.
Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
Measured: 2-10 days before sugery
Preoperative stair climbing before TKA compared to baseline
To compare stair climbing after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA.
Assessment is an indicator for stair climbing:
- Stair Climbing Test (SCT)
Measured: 2-10 days before sugery
Preoperative stair climbing before TKA compared to usual care
To compare stair climbing after preoperative physical therapy immediately before TKA to usual care.
Assessment is an indicator for stair climbing:
- Stair Climbing Test (SCT)
Measured: 2-10 days before sugery
Preoperative walking performance before TKA compared to baseline
To compare walking performance after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA.
Assessment are indicators for walking performance:
- 2-minute walking test (2MWT)
- Timed-Up and Go (TUG)
Measured: 2-10 days before sugery
Preoperative walking performance before TKA compared to usual care
To compare walking performance after preoperative physical therapy immediately pre-surgery to usual care in patients awaiting a TKA.
Assessment are indicators for walking performance:
- 2-minute walking test (2MWT)
- Timed-Up and Go (TUG)
Measured: 2-10 days before sugery
Preoperative strength before TKA compared to baseline
To compare strength after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA.
Assessments are indicators for strength:
- 5-times Sit To Stand (5STS): indicator for knee strength
- Handgrip Strength (HGS): indicator for strength of lower extremities
Measured: 2-10 days before sugery
Preoperative strength before TKA compared to usual care
To compare strength after preoperative physical therapy immediately pre-surgery to usual care in patients awaiting a TKA.
Assessments are indicators for strength:
- 5-times Sit To Stand (5STS): indicator for knee strength
- Handgrip Strength (HGS): indicator for strength of lower extremities
Measured: 2-10 days before sugery
Preoperative activity level before TKA compared to baseline
To compare activity level before TKA to baseline.
Assessments:
- Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.
Measured: 2-10 days before surgery
Preoperative activity level beforeTKA compared to usual care
To compare activity level before TKA to patients with usual care.
Assessments:
- Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.
Measured: 2-10 days before surgery
Preoperative level of pain compared to baseline
To compare the level of pain after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA.
Assessment:
- Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.
Measured: 2-10 days before sugery
Preoperative level of pain compared to usual care
To compare the level of pain after preoperative physical therapy immediately pre-surgery to patients with usual care.
Assessment:
- Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.
Measured: 2-10 days before sugery
Preoperative quality of life compared to baseline
To compare the quality of life after preoperative physical therapy immediately pre-surgery to baseline in patients awaiting a TKA.
Assessment:
- Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.
Measured: 2-10 days before sugery
Preoperative quality of life compared to usual care
To compare the quality of life after preoperative physical therapy immediately pre-surgery to patients with usual care.
Assessment:
- Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.
Measured: 2-10 days before sugery
Preoperative knee joint mobility compared to baseline
To assess preoperative range of motion (ROM) compared to baseline.
Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible.
Assessment: Degrees [°] Notation: Neutral-zero-method
Measured: 2-10 days before surgery
Preoperative knee joint mobility compared to usual care
To assess preoperative range of motion (ROM) compared to patients awaiting TKA with usual care.
Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible.
Assessment: Degrees [°] Notation: Neutral-zero-method
Measured: 2-10 days before surgery
Postoperative functional performance 6 weeks after TKA compared to baseline
To compare functional performance 6 weeks after TKA compared to baseline.
Assessment:
Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
Measured: 6 weeks postoperative
Postoperative functional performance 6 weeks after TKA compared to usual care
To compare functional performance 6 weeks after TKA to patients with usual care.
Assessment:
Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
Measured: 6 weeks postoperative
Postoperative activity level 6 weeks after TKA compared to baseline
To compare activity level 6 weeks after TKA to baseline.
Assessments:
- Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.
Measured: 6 weeks postoperative
Postoperative activity level 6 weeks after TKA compared to usual care
To compare activity level 6 weeks after TKA to patients with usual care.
Assessments:
- Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.
Measured: 6 weeks postoperative
Postoperative level of pain 6 weeks after TKA compared to usual care
To compare the level of pain 6 weeks after TKA to patients with usual care.
Assessment:
- Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.
Measured: 6 weeks postoperative
Postoperative level of pain 6 weeks after TKA compared to baseline
To compare the level of pain 6 weeks after TKA to baseline.
Assessment:
- Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.
Measured: 6 weeks postoperative
Feasibility of prehabilitation program: Number of participants with adherence to the therapy sessions of at least 80%
To assess feasibility of preoperative physical therapy intervention in patients awaiting a TKA (defined as adherence to the therapy sessions of at least 80%).
Measured: 6 weeks postoperative
Dischargeability: Length of Stay in hospital (LoS)
To compare readiness for discharge from the hospital after surgery after preoperative physical therapy in patients awaiting a TKA to patients treated with usual care.
Measured: 6 weeks postoperative
Postoperative functional performance 3 months after TKA compared to baseline
To compare functional performance 3 months after TKA to baseline.
Assessment:
Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
Measured: 3 months postoperative
Postoperative functional performance 3 months after TKA compared to usual care
To compare functional performance 3 months after TKA to patients with usual care.
Assessment:
Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
Measured: 3 months postoperative
Postoperative stair climbing 3 months after TKA compared to baseline
To compare stair climbing 3 months after TKA to baseline.
Assessment is an indicator for stair climbing:
- Stair Climbing Test (SCT)
Measured: 3 months after sugery
Postoperative stair climbing 3 months after TKA compared to usual care
To compare stair climbing 3 months after TKA to usual care.
Assessment is an indicator for stair climbing:
- Stair Climbing Test (SCT)
Measured: 3 months after sugery
Postoperative walking performance 3 months after TKA compared to baseline
To compare walking performance 6 weeks after TKA to baseline.
Assessment are indicators for walking performance:
- 2-minute walking test (2MWT)
- Timed-Up and Go (TUG)
Measured: 3 months after surgery
Postoperative walking performance 3 months after TKA compared to usual care
To compare walking performance 6 weeks after TKA to usual care.
Assessment are indicators for walking performance:
- 2-minute walking test (2MWT)
- Timed-Up and Go (TUG)
Measured: 3 months after surgery
Postoperative strength 3 months after TKA compared to baseline
To compare strength 3 months after TKA to baseline.
Assessments are indicators for strength:
- 5-times Sit To Stand (5STS): indicator for knee strength
- Handgrip Strength (HGS): indicator for strength of lower extremities
Measured: 3 months after sugery
Postoperative strength 3 months after TKA compared to usual care
To compare strength 3 months after TKA to ususal care.
Assessments are indicators for strength:
- 5-times Sit To Stand (5STS): indicator for knee strength
- Handgrip Strength (HGS): indicator for strength of lower extremities
Measured: 3 months after sugery
Postoperative activity level 3 months after TKA compared to baseline
To compare activity level 3 months after TKA to baseline.
Assessments:
- Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.
Measured: 3 months postoperative
Postoperative activity level 3 months after TKA compared to usual care
To compare activity level 3 months after TKA to usual care.
Assessments:
- Tegner Activity Scale (TAS): The minimum score = 0, the maximum score = 10, where a higher score indicates a better outcome.
Measured: 3 months postoperative
Postoperative level of pain 3 months after TKA compared to baseline
To compare the level of pain 3 months after TKA to baseline.
Assessment:
- Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.
Measured: 3 months postoperative
Postoperative level of pain 3 months after TKA compared to usual care
To compare the level of pain 3 months after TKA to patients with usual care.
Assessment:
- Numeric rating scale (NRS): The minimum score = 0, the maximum score = 10, where a lower score indicates a better outcome.
Measured: 3 months postoperative
Postoperative quality of life 3 months after TKA compared to baseline
To compare the quality of life 3 months after TKA compared to baseline.
Assessment:
- Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.
Measured: 3 months postoperative
Postoperative quality of life 3 months after TKA compared to usual care
To compare the quality of life 3 months after TKA to patients with usual care.
Assessment:
- Short Form 12 (SF-12): The minimum score = 0, the maximum score = 100, where a higher score indicates a better outcome.
Measured: 3 months postoperative
Postoperative knee joint mobility 3 months after TKA compared to baseline
To assess postoperative range of motion (ROM) 3months after TKA compared to baseline.
Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible.
Assessment: Degrees [°] Notation: Neutral-zero-method
Measured: 3 months after surgery
Postoperative knee joint mobility 3 months after TKA compared to usual care
To assess postoperative range of motion (ROM) 3 months after TKA compared to baseline.
Active knee joint mobility is assessed with a long-legged goniometer in supine position, where the patient pulls his/her heel towards his/her buttocks and extends his/her knee as far as possible.
Assessment: Degrees [°] Notation: Neutral-zero-method
Measured: 3 months after surgery
Postoperative Global Impression of Change compared to usual care
To assess postoperative Global Impression of Change 3 months after TKA compared to usual care.
Assessment: Patient Global Impression of Change (PGIC)-Score: The minimum score = 0, the maximum score = 7, where a lower score indicates a better outcome
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start29 Apr 2021
- Primary completion30 Sep 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Johannes Scherr, Prof., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314985
- Sponsor's protocol ID
- BASEC-Nr. 2020-03060
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make Individual Participant Data (IPD) available.
Publications
Granicher P, Kocher M, de Bie R, Swanenburg J, Scherr J. Exploring feasibility of health-related quality of life assessments and pain diaries in patients undergoing prehabilitation before total knee arthroplasty: a pilot study. BMC Musculoskelet Disord. 2025 Oct 23;26(1):988. doi: 10.1186/s12891-025-09184-9.
PubMed 41131492
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05314985
- Acronym / sponsor ID
- BASEC-Nr. 2020-03060
- Conditions
- Osteoarthritis, Knee
- Keywords
- Preoperative Exercise, Physical Therapy Modalities, Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehab Group / Intervention Group | Experimental | Other: Prehab intervention4 to 8 weeks of preoperative physical therapy training and education intervention before total knee replacement surgery. |
| Control Group | No intervention | –Usual care / no treatment before total knee replacement surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female participants (≥18 years)
- Patients receiving a unilateral TKA
- Signed informed consent after being informed
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehab interventionIndividual training program containing strengthening, sensori-motor, joint mobilisation and endurance exercises as well as educational inputs concerning perioperative procedure and instructions on e.g. how to walk with crutches. | Other | Prehab Group / Intervention Group |
Primary outcome
Preoperative functional performance compared to baseline
Time frame: 2-10 days before sugery
To compare functional performance immediately pre-surgery after preoperative physical therapy in patients awaiting a TKA to baseline. Assessment: Knee Osteoarthritis Outcome Score (KOOS). The minium score = 0 , the maximum score = 100, where a higher score indicates a better outcome.
40 secondary outcomes
Preoperative functional performance compared to usual care
Time frame: 2-10 days before sugery
Preoperative stair climbing before TKA compared to baseline
Time frame: 2-10 days before sugery
Preoperative stair climbing before TKA compared to usual care
Time frame: 2-10 days before sugery
Preoperative walking performance before TKA compared to baseline
Time frame: 2-10 days before sugery
Preoperative walking performance before TKA compared to usual care
Time frame: 2-10 days before sugery
Preoperative strength before TKA compared to baseline
Time frame: 2-10 days before sugery
Preoperative strength before TKA compared to usual care
Time frame: 2-10 days before sugery
Preoperative activity level before TKA compared to baseline
Time frame: 2-10 days before surgery
Preoperative activity level beforeTKA compared to usual care
Time frame: 2-10 days before surgery
Preoperative level of pain compared to baseline
Time frame: 2-10 days before sugery
Preoperative level of pain compared to usual care
Time frame: 2-10 days before sugery
Preoperative quality of life compared to baseline
Time frame: 2-10 days before sugery
Preoperative quality of life compared to usual care
Time frame: 2-10 days before sugery
Preoperative knee joint mobility compared to baseline
Time frame: 2-10 days before surgery
Preoperative knee joint mobility compared to usual care
Time frame: 2-10 days before surgery
Postoperative functional performance 6 weeks after TKA compared to baseline
Time frame: 6 weeks postoperative
Postoperative functional performance 6 weeks after TKA compared to usual care
Time frame: 6 weeks postoperative
Postoperative activity level 6 weeks after TKA compared to baseline
Time frame: 6 weeks postoperative
Postoperative activity level 6 weeks after TKA compared to usual care
Time frame: 6 weeks postoperative
Postoperative level of pain 6 weeks after TKA compared to usual care
Time frame: 6 weeks postoperative
Postoperative level of pain 6 weeks after TKA compared to baseline
Time frame: 6 weeks postoperative
Feasibility of prehabilitation program: Number of participants with adherence to the therapy sessions of at least 80%
Time frame: 6 weeks postoperative
Dischargeability: Length of Stay in hospital (LoS)
Time frame: 6 weeks postoperative
Postoperative functional performance 3 months after TKA compared to baseline
Time frame: 3 months postoperative
Postoperative functional performance 3 months after TKA compared to usual care
Time frame: 3 months postoperative
Postoperative stair climbing 3 months after TKA compared to baseline
Time frame: 3 months after sugery
Postoperative stair climbing 3 months after TKA compared to usual care
Time frame: 3 months after sugery
Postoperative walking performance 3 months after TKA compared to baseline
Time frame: 3 months after surgery
Postoperative walking performance 3 months after TKA compared to usual care
Time frame: 3 months after surgery
Postoperative strength 3 months after TKA compared to baseline
Time frame: 3 months after sugery
Postoperative strength 3 months after TKA compared to usual care
Time frame: 3 months after sugery
Postoperative activity level 3 months after TKA compared to baseline
Time frame: 3 months postoperative
Postoperative activity level 3 months after TKA compared to usual care
Time frame: 3 months postoperative
Postoperative level of pain 3 months after TKA compared to baseline
Time frame: 3 months postoperative
Postoperative level of pain 3 months after TKA compared to usual care
Time frame: 3 months postoperative
Postoperative quality of life 3 months after TKA compared to baseline
Time frame: 3 months postoperative
Postoperative quality of life 3 months after TKA compared to usual care
Time frame: 3 months postoperative
Postoperative knee joint mobility 3 months after TKA compared to baseline
Time frame: 3 months after surgery
Postoperative knee joint mobility 3 months after TKA compared to usual care
Time frame: 3 months after surgery
Postoperative Global Impression of Change compared to usual care
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 41131492Granicher P, Kocher M, de Bie R, Swanenburg J, Scherr J. Exploring feasibility of health-related quality of life assessments and pain diaries in patients undergoing prehabilitation before total knee arthroplasty: a pilot study. BMC Musculoskelet Disord. 2025 Oct 23;26(1):988. doi: 10.1186/s12891-025-09184-9.
- Information on the prehabilitation program at University Hospital Balgrist.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make Individual Participant Data (IPD) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Scherr, Prof. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehab intervention in people with Osteoarthritis, Knee, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative functional performance compared to baseline (time frame: 2-10 days before sugery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.