None listed
Conditions
Brief summary
We will investigate the impact of a novel exergaming intervention using the Wii Fit gaming system on signs and symptoms of knee osteoarthritis (OA). The hypothesis is that participants will enjoy the mode of exercise delivery, and adhere better to the intervention thus achieving significant improvement in clinical outcomes, compared to a control group receiving usual care. It is a feasibility study (12 participants in each group) that will not determine if exergaming influences outcome, but will evaluate whether there is justification for conducting a similar larger RCT. It will evaluate study procedures and acceptability, as well as provide data to inform sample size for a future RCT. It will be a two-arm intervention study with one intervention group and one control group. Twelve participants will be randomly assigned to each group. Group A – the active intervention group will attend one physiotherapy session per week for 12 weeks. The physiotherapist will use the Wii Fit gaming system to provide an individualised programme aimed at strengthening the major muscle groups controlling the knee. Six games or exercises will be completed using the Wii Fit, taking 45 minutes approximately. Three or four participants will attend concurrently to create a group environment, a preferred mode of exercise for older people. Participants will be given a Wii Fit bundle, including all elements needed to complete the programme at home. A research assistant will visit them and set up the system on their own television set, and be available to answer questions. Participants will be asked to repeat their exercise programme twice per week at home. Group B – control group will continue with usual care for a period of 12 weeks, which may include normal exercise, medication and other usual activities. Following the primary follow-up assessment at 12 weeks, they will undertake the Wii Fit intervention as for Group A. Beneficial effects of exercise for management of knee OA are well-recognised and it would therefore be unethical to deprive the control group of a known beneficial intervention. Control group participants knowing they will receive a delayed intervention, may be less likely to drop-out, thus improving retention rates of the study. Clinical outcomes will be evaluated at 12 weeks for both groups, including muscle strength, self-reported knee instability, pain, function and physical performance; also participants’ self-confidence, self-efficacy, rating of change and enjoyment of the intervention. Feasibility outcomes will be evaluated at 12 weeks and on completion of the study.
Interventions
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 su
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.
Sponsors
Dr Cathy Chapple
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
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, 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. 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
Exclusion criteria
Previous lower limb joint arthroplasty, lower limb injury/surgery/physiotherapy treatment/knee joint injection for knee osteoarthritis in previous 12 months, consultation with orthopaedic specialist for knee OA/on waiting list for knee joint replacement, commencement of new medication for OA (previous 1 month); other forms of arthritis, plus comorbidities that will preclude safe participation in moderate exercise : uncontrolled or severe hypertension, cardiac arrythmia, uncontrolled cardiovascular disease, unstable diabetes, inability to attend physiotherapy sessions
Outcome results
None listed