None listed
Conditions
Brief summary
Lack of physical activity is a major health issue for people with osteoarthritis of the knee leading to increased risks of cardiovascular disease. Only about 1 in 10 people with knee osteoarthritis meets the current physical activity guidelines of at least 150 minutes of moderate intensity activity in minimum of 10 minute bouts each week. It is not known if it is safe or feasible to encourage these people to increase their physical activity level as recommended in the guidelines. This project will determine how much physical activity in the form of walking can be safely and feasibly prescribed for people with severe knee osteoarthritis in the community. Patients that attend the orthopaedic outpatients department at Eastern Health will be invited to participate. We will apply methods commonly used in drug trials to work out how much of a medication can be safely prescribed, but apply these methods to physical activity to work out the maximum tolerated dose of walking for people with severe knee osteoarthritis. The project will begin with prescribing small doses of walking, and measuring the participants’ responses to determine if the prescribed dose is tolerated safely. For example, the walking dose may cause substantial knee pain for the participant that does not settle quickly with rest. This response is termed an adverse or undesired event. If there are no adverse events, the prescribed dose of walking will be escalated in the next independent group of participants until the maximum tolerated dose is reached. This is a phase I dose response trial to characterise the safety profile of a treatment. The outcome of this study will provide evidence for the level of physical activity that can be safely tolerated by people with knee osteoarthritis, and assist health professionals to prescribe safe amounts of walking.
Interventions
This is a phase I dose-response trial to find out how much physical activity, in the form of walking, can be prescribed for people with knee osteoarthritis in terms of safety and feasibility.
Groups of 3 participants will be individually supervised to walk at a prescribed level of physical activity over one week. This prescribed level of physical activity will not change for individual participants but may escalate for subsequent groups of participants.
The walking doses will be in minutes per
This is a phase I dose-response trial to find out how much physical activity, in the form of walking, can be prescribed for people with knee osteoarthritis in terms of safety and feasibility. Groups of 3 participants will be individually supervised to walk at a prescribed level of physical activity over one week. This prescribed level of physical activity will not change for individual participants but may escalate for subsequent groups of participants. The walking doses will be in minutes per week, of at least moderate intensity, in a minimum of 10 minute bouts, so that the doses can be compared with the current physical activity guidelines. The dose level of prescribed physical activity will follow a modified Fibonacci scheme starting with an initial dose of 10 minutes per week of moderate intensity supervised walking for the first group of participants. Moderate intensity walking will be defined as a 3 on the modified Borg 0-10 perceived exertion scale, where 3 = “I am still comfortable but am breathing a little harder.” Dose escalation will depend on the presence or absence of adverse incidents among the group of 3 participants. Depending on the feasibility and safety of the prescribed dose of walking, the dose may or may not be escalated between subsequent groups of participants. Dose escalation will start with early larger dose increments between groups which get smaller for higher doses until the guideline stopping value of 150 minutes of walking per week is reached (i.e. 10, 20, 35, 50, 70, 95, 120, 150 mins) The trial will stop when/if a group of participants can achieve 150 minutes of prescribed walking as this reflects physical activity guidelines.
Sponsors
Jason Wallis
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Adult aged at least 50 years and living independently in the community; (2) diagnosed with moderate-to-severe knee osteoarthritis rated as grade III or IV; (3) able to understand English; (4) able to participate safely in the moderate-intensity physical activity trial using the 7-item Physical Activity Readiness Questionnaire.
Exclusion criteria
(1) live in supported accommodation such as a nursing home; (2) they report their daily resting level of pain to be 9 or 10 on an 11 point Numerical Pain Rating Scale. This level of pain may be indicative of a more serious pathology such as acute or inflammatory condition; (3) high or very high levels of psychological distress as measured by the Kessler 10 questionnaire with a K10 score > 21; (4) have an intellectual or mental impairment as measured by the Short Portable Mental Status Questionnaire with a score of 7 or less; (5) have a systemic arthritic condition such as rheumatoid arthritis; (6) have a neurological condition such as Parkinson’s disease or stroke that affects walking; (7) had knee surgery or intra-articular corticosteroid injection within past six months; (8) currently (within four weeks) using oral corticosteroids.
Outcome results
None listed