Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2017
INTERVENTION: All participants will receive a 12‐week exercise therapy intervention using the Wii Fit gaming platform. Participants randomised to the control group will have their intervention delayed until after the primary outcome time point at 12‐weeks. The exercises will be tailored to individual participants by a New Zealand registered physiotherapist with experience in management of osteoarthritis, and who has been trained to use the Wii Fit. Exercise sessions will take place once per week under the supervision of the physiotherapist at the School of Physiotherapy Clinics. It will be a group situation with other participants completing their tailored programmes on Wii Fit platforms at the same time. Sessions will consist of up to 6 different exercises/games, with each performed for around 5 minutes. The exercises will focus on lower limb muscle strengthening, thus requiring a suitable level of challenge to produce muscle fatigue. These exercises/games will be preceded and followed by generic warm‐up and warm down activities also on the Wii Fit. The total time for a supervised exercise session will be around 45 minutes. Exercises will be progressed by the physiotherapist to maintain a challenging level of performance for participants. Participants will also be provided with a Wii Fit for home use for the duration of the 12‐week exercise programme. This will be set‐up for them by a research assistant. They will perform two further exercise sessions per week, using the same exercises as taught by the physiotherapist in the supervised sessions. Number and duration of exercises will be similar. The target total intervention is a 12‐week exercise programme, performed three times per week (once supervised, twice independently at home) for up to 45minutes per session. Compliance with the study intervention protocol will be monitored by exercise diaries, the physiotherapist’s notes and also by the built in monitor on the Wii Fit. Participants will be taught how to use the Wii Fit in their own homes by the research assistant, who will also be available by telephone or e‐mail to solve any problems participants may have with using the gaming platform. They will also be supplied with printed materials to help them use the system and complete their prescribed exercise programme. CONDITION: Knee osteoarthritis PRIMARY OUTCOME: Feasibility measure: ; Ability to recruit 24 participants with knee OA and self‐reported knee instability in a 4 month period ; Feasibility measure: 80% participants compliant with study protocol. Compliance equates to 8 or more supervised visits completed and at least one home session per week completed for duration of trial. Home exercise will be monitored with the Wii Fit machine and exercise logs. ; Feasibility measure: recording and management of adverse events. All adverse events reported in timely manner to trial monitoring team (PI and AIs) < 24hrs, and successful management implemented, including referral to medical practitioner if necessary. Adverse events include exacerbation of knee pain or swelling that does not subside in 48 hrs. SECONDARY OUTCOME: Enjoyment of exercising using the Wii Fit gaming platform will be evaluated using the Physical Activity Enjoyment Scale (PACES) (Graves 2010). Greater enjoyment has the potential to result in better adherence to exercise. Feasibility measure: 90% of participants retained at follow‐up ; ; (Wadell 1993). Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis: ; 30 second sit to stand test Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis: ; 40 metre timed walk Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis: 2. Have experienced actual instability or knee buckling in the previous 3 months, or a sensation of instability or knee buckling in the previous 3 months. ; Feasibility measure: Data collection methods are effective, providing good quality data for statistical analysis to be trialled, and variance established Feasibility measure: Trial protocols and procedures are acceptable to physiotherapists providing the intervention. Evaluated by semi‐structured interview. Questions will include, "was the exercise programme achievable?", "was the time required for exercise realisitic?", "were there any problems with the exercise programme?" "was the time required for completing the assessments realistic?", "were there any problems with the assessment sessions/outcome measures?", "are there any suggestions you would like to make?" ; Feasibility measure: Were the trial protocols and interventions acceptable to participants in the trial. Evaluated by semi‐structured interview. Questions will include, "was the exercise programme achievable?", "was the time required for exercise realisitic?", "were there any problems with the exercise programme?" "was the time required for completing the assessments acceptable?", "are there any suggestions you would like to make?", "would you be happy to participate in a similar trial in the future?" ; Global Rating of Change Score (GRCS): patient self –reported perception of the degree to which their symptoms/condition has changed since enrolment in the study (Currier et al 2007) Muscle strength. The quadricpes and hamstrings muscle groups will be evaluated pre and post intervention using the Biodex System 3 Pro isokinetic dynamometer (Biodex Medical Systems, NY) at a velocity of 60 degrees/second. An established testing protocol will be used (Segal et al 2009) and results normalised for body size using allometric scaling equations. Pain, function, stiffness and self‐confidence in knee: self‐report using The Knee injury and Osteoarthritis Outcome Score (KOOS) (ROOS et al 2003) Participant self‐report of falls in the previous 12 months and between enrolment and 12 week follow‐up assessment Participants expectations of the Outcome Expectations for Exercise Scale‐2 (OEE‐2) which evaluates an individual's expectation that a given behaviour will result in a known outcome (Resnick 2005). SEE‐2 includes both positive and negative expectations. There is some prelimary evidence for reliability and validity of the scale for use with older adults (Resnick 2005). By evaluating pre and post intervention, any change in outcome expectation for exercise will be identified. People with knee osteoarthritis may exhibit pain‐related fear, or fear of movement. This has the potential to influence their exercise behaviour, or adherence to exercise, and will be evalauted using the Fear Avoidance Pain Questionnaire ‐ Physical Activity subscale (FABQ‐PA) INCLUSION CRITERIA: 1. Adults with knee pain meeting ACR Clinical Criteria for Classification of Knee Osteoarthritis: Pain on most days in the last month (>15 days) plus 3 of the following: age > 50 years, crepitus on active motion, bony tenderness, bony enlargement, < 30 minutes of morning stiffness, no palpable warmth of synovium, 3. Have capacity to understand the trial information, consent form and documents 4. Have access to television on regualr basis, and willing to have Wii Fit equipment installed for duration of intervention ; Timed stair climb test (10 steps up and 10 steps down) Physical Performance Measures (PPM) recommended for clinical trials of osteoarthritis: Timed Up and Go (TUG) Self‐efficacy: Assessment of participants perceived self‐efficacy or confidence to perform the intended exercise using the Self‐Efficacy for Exercise Scale (SEE) (Resnick & Jenkins 2000). Higher self‐efficacy makes it more likely an individual will take part in the exercise, invest more effort and persist with the exercise behaviour. Self‐reported knee instability using a question from the Knee Outcome Survey ‐ Activities of daily living scale (Irrgang et al 1998) where the participant is asked if they have experienced any buckling or shifting of the knee in the previous 3 months and the impact on function. The sensation of any buckling or shifting of the knee in the previous 3 months is also included, the number of episodes of instability, and whether any of these episodes resulted in a fall.
Epistemonikos ID: d21b5571fdda560f075cefe84dee243d7933e1df
First added on: Aug 25, 2024