None listed
Conditions
Brief summary
Osteoarthritis (OA) is a common and debilitating condition affecting millions worldwide, with no known cure. Physical activity is beneficial for managing OA, but most patients fail to meet recommended activity levels. Walking is a safe, low-cost, accessible form of exercise suitable for OA patients. The Walk with Ease program, initially from the US, is a 12-week walking program designed to help OA patients manage pain and symptoms while staying active. It has proven to reduce pain, stiffness, and improve function in people with moderate to severe pain (greater than 4/10), also boosting physical activity levels in individuals with arthritis. This study will test whether Walk with Ease Australia has an effect on physical activity levels in Australians with OA through a two-arm, parallel, randomised controlled trial using a hybrid type 1 effectiveness-implementation design. The primary endpoint is assessed at 12 weeks. After screening and consenting, participants are randomized into either the Walk with Ease Australia plus Fitbit group or the Fitbit-only group. Surveys are completed at baseline (T0), six weeks (T1), 12-weeks (T2), and follow-ups at six and 12 months (T3 and T4). We expect that people assigned to the Walk with Ease Australia will have higher physical activity levels, compared to control at 12 weeks.
Interventions
The intervention will be the self-directed 12-week Walk with Ease Australia program. The Walk with Ease Australia program has been adapted from a 6-week self-directed walking program which was developed by the Thurston Arthritis Research Centre and the Institute on Aging of the University of North Carolina, for use in the USA. The program participants are encouraged to walk 3–5 times a week, with a weekly increase in duration. Each week, participants are prompted to read chapters from the Walk w
The intervention will be the self-directed 12-week Walk with Ease Australia program. The Walk with Ease Australia program has been adapted from a 6-week self-directed walking program which was developed by the Thurston Arthritis Research Centre and the Institute on Aging of the University of North Carolina, for use in the USA. The program participants are encouraged to walk 3–5 times a week, with a weekly increase in duration. Each week, participants are prompted to read chapters from the Walk with Ease workbook to equip them with the tools and knowledge to achieve their walking goals, including: initial, midway, and end-point self-assessments, a guide to setting up a walking plan, a 5-step guide on what should be included in a walking session (warm-up, gentle stretching, walking, and speed up, cool down, and gentle stretching), the frequency, intensity, time (duration), and type of training (FITT) principles, and a walking diary (“Companion Workbook”). The Walk with Ease Australia program is a self-directed physical activity program and it is up to the participant to decide how much to walk based on their own goals. Once participants have completed consent, screening and eligibility processes they will be asked to complete the baseline questionnaire and receive “blinded” Fitbits (activity tracking monitors) to monitor their physical activity levels (primary outcome measure). The “blinded” Fitbits will be Fitbits that have all goal notifications and prompts to move turned off and step count will not be visible on their home screen. Access to step count through the Fitbit mobile app cannot be disabled so it is possible that participants will see their step count if they access the app. Following the 14-day data collection period, participants will be randomised and sent an electronic version of the 12-week self-directed Walk with Ease Australia book, followed by a physical copy by mail. Participants will also be invited to join a private CASCADE-OA Facebook group.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be aged 45 years or older, Have activity-related hip or knee joint pain, Is willing to participate in community walking Have an average pain rating of 3 or more on the 11-point numerical rating scale (NRS, 0-10), Be able to walk for at least 10 minutes at any pace/intensity (aided or unaided), Have access to a GPS-tracking smartphone, and Have internet access. Be able to read and understand English. Will be residing in Australia for the next 12 months Potential participants must also be considered safe to participate in a walking trial using the Adult Pre-Screening Screening System (APSS), and do not have joint-related stiffness or any morning stiffness that lasts beyond 30 minutes
Exclusion criteria
People will not be eligible to participate if they do not meet the inclusion criteria above, have co-existing inflammatory arthritis including rheumatoid arthritis and gout, or are already meeting the minimum physical activity guideline requirements of 150 minutes of moderate physical activity or 75 minutes of vigorous activity per week.
Outcome results
None listed