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van CCT (UK)

van CCT (UK)

activity coach in TKA following a homebased exercise program

- candidate number21831
- NTR NumberNTR5109
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-mrt-2015
- Secondary IDsNL52370.044.15 
- Public Titleactivity coach in TKA following a homebased exercise program
- Scientific TitleThe use of an activity coach in patients after a TKA following a homebased exercise program
- hypothesisHypothesis is that patients following a homebased exercise program after a TKA recover better if they receive an additive activity coach
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty
- Inclusion criteria• receive a TKA
• Preoperative 2 Minutes Walk Test > 120 metre
• BMI<30
• Absence of bad habit, Gang Analyse Lijst Nijmegen the following items ‘no’
o Too little arm sway
o Too little knee extension
o Too little knee flexion
• Active coping, measured with the Patiënt Activatie Meting (PAM) >60 points
• signed informed consent
• independent in activities of daily living
• supplementary insurance for physical therapy or declare oneself ready to pay 180 euro for physical therapy
- Exclusion criteria• Comorbidities (such as heart or long diseases, orthopaedic problems, cancer, etc) so that the patient could not follow a homebased exercise program and/or could not walk dynamic
• Postoperative complications, open wounds, infections, >3 days staying in the hospital.
• known with severe mental disorders
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate1-nov-2016
- Target number of participants0
- InterventionsControl group: homebased exercise program of 2 weeks (mobility, muscle force) instructed by specialised physical therapists.
Intervention group: homebased exercise program of 2 weeks (mobility, muscle force) instructed by specialised physical therapists and use of the activity coach.
The activity coach is developed by the Roessingh Research & Development (RRD) and is researched on other patient populations, such as COPD and Total Hip Arthroplasty. It gives the patient feedback about his activity level and doing exercises.
de patiënt feedback over zijn activiteitenniveau en het uitvoeren van oefeningen.
- Primary outcomephysical functioning Timed Up and Go (TUG)
- Secondary outcomephysical functioning: 2 Minutes Walk Test (2MWT)
activity level: activity diary and 3D accelerometer
activity and participation level: Knee Osteoarthritis Outcome Score (KOOS)
health care consumption in relation to TKA till 1 year postoperative
- Timepointspreoperative
postoperative start homebased exercise program (3 days after surgery)
postoperative 2 weeks
postoperative 6 weeks
postoperative 3 months
postoperative 1 year
- Trial web site
- statusplanned
- Sponsor/Initiator MST Enschede
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryPatients in which the expectancy is that they could rapidly recover after a Total Knee Arthroplasty should not always go to the physical therapist. This group of patients could benefit from a homebased exercise program. The effect of exercise training depends on adherence to the activity instructions. The activity coach is an app on a smartphone. Patients wear the smartphone the whole day with them. The activity coach measures the activity level of the patient and gives feedback on it to the patient. The hypothesis is that if patients receive an activity coach alongside a home based exercise program, they are more active in Activities of Daily Living. This results in better physical functioning and better recovery after a TKA
- Main changes (audit trail)
- RECORD22-mrt-2015 - 26-apr-2015

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