None listed
Conditions
Brief summary
Knee osteoarthritis (OA) is a major public health problem. Exercise is recommended by all clinical guidelines for managing pain in knee OA, however, effects of exercise on pain and function outcomes are only modest. This may be due to poor exercise adherence amongst knee OA sufferers. There is evidence that the use of text messaging as a behaviour change adherence tool can be effective in the healthcare setting for a variety of conditions. To date the use of SMS messages as an adherence tool for exercise has not been assessed in the knee OA population. Our primary aim will therefore be to investigate the effects of adding a behaviour change embedded text message intervention, to a 6 month home based exercise program for knee osteoarthritis. Participants who complete a previous RCT (ACTRN 12617001013358) will be randomly allocated to one of two groups: i) SMS adherence intervention - a home based exercise program completed three times weekly for 24 weeks PLUS an automated, semi-personalised, mobile phone text message intervention, embedded in behaviour change theory to promote adherence to the exercise program. ii) No adherence support control - a home based exercise program completed three times weekly for 24 weeks, independently with no adherence support. Primary outcomes are self-reported adherence measures and secondary outcomes include self-reported pain and function. The primary timepoint is 24 weeks.
Interventions
Participants will be randomly allocated to either 1) SMS adherence intervention or 2) no adherence support control.
Participants in both groups will be expected to continue their home exercise program prescribed to them in a previous study, the TARGET study (Trial Id: ACTRN12617001013358). Participants will complete their prescribed home exercise program 3 times/week for 24 weeks. Each home exercise session will take approximately 20 minutes.
In addition participants in the SMS intervention
Participants will be randomly allocated to either 1) SMS adherence intervention or 2) no adherence support control. Participants in both groups will be expected to continue their home exercise program prescribed to them in a previous study, the TARGET study (Trial Id: ACTRN12617001013358). Participants will complete their prescribed home exercise program 3 times/week for 24 weeks. Each home exercise session will take approximately 20 minutes. In addition participants in the SMS intervention will receive text messages over the 24 week period aiming to facilitate adherence to the home exercise program. Message content has been developed drawing on behaviour change theory and will address common barriers and facilitators to exercise participation previously identified in the knee OA literature. The messaging system will be automated, personalized using first names and be semi-interactive. Participants will receive approximately 4-5 messages per week initially, dependent on their level of home exercise participation. At the start of the program all participants will receive 2 facilitator to exercise messages per week and a text message asking home many times they completed their home exercise program in the previous week. Participants who complete their home exercise program less than 3 times in the previous week will receive additional messages to identify and address the possible barriers to their exercise participation. Message frequency will gradually reduce over the 24 weeks, so as to not become burdensome to participants. Participants in both groups will receive an optional exercise log book to record their weekly exercise practice over the 24 week period.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who complete a previous RCT (TARGET study, ACTRN 12617001013358) investigating the effect of two different exercise programs for people with medial knee osteoarthritis and obesity will be automatically enrolled into this trial. The inclusion criteria for the previous RCT are; I. aged 50 years and above; II. report knee pain on most days of the past month; III. suffered knee pain for 3 months or more; IV. report a minimum average overall pain score of 4 on an 11-point numeric rating scale over the previous week V. demonstrate tibiofemoral osteophytes on x-ray VI. obesity (BMI of 30 kg/m2 and over) VII. have a mobile phone that has text messaging functionality and be happy to receive text message reminders if required during the study
Exclusion criteria
The exclusion criteria are; I. Lateral joint space narrowing greater than or equal to medial joint space narrowing on x-ray; II. knee surgery/joint injection in past 6 months or planned surgery in the next 9 months; III. current or past (4 weeks) oral corticosteroids; IV. systemic arthritic conditions; V. past knee fracture or malignancy VI. past hip/knee joint replacement/tibial osteotomy; VII. other condition currently effecting lower limb function; VIII. participation in knee strengthening or neuromuscular exercise in past 6 months or planning to start exercise in next 9 months; IX. unable to walk unaided. X. unable to commit to study requirements (Unable to attend study appointments or complete study outcomes)
Outcome results
None listed