Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one)

Abstract

BackgroundOsteoarthritis (OA) is not limited to joint pain and stiffness, which can lead to disability; it is also linked to comorbidities such as overweight, obesity and fears and beliefs related to the pathology. The knee OA population appears more affected by these risk factors and has a lower physical activity (PA) level than the general population. The key challenge for OA treatment is increasing the PA level to decrease the risk factors.MethodsWe aim to perform a prospective, multicentric, quasi-randomized controlled trial with an alternate-month design (1-month periods). People aged 50–75 years old with symptomatic knee OA (stage I-IV Kellgren and Lawrence scale) with low and moderate PA level will be included in 3 spa therapy resorts. The experimental arm will receive 5 self-management exercise sessions (1.5 h each; education, aerobics, strength training, range of motion) + an information booklet + 18 sessions (1 h each) of spa therapy treatment (STT). The active comparator arm will receive an information booklet + 18 sessions of STT. The primary outcome will be a change at 3 months in PA level (International Physical Activity Questionnaire short form score). Secondary outcomes will be function (WOMAC) pain (numerical scale), anxiety/depression (HAD), fears and beliefs about OA (KOFBeQ) and arthritis self-efficacy (ASES). The barriers to and facilitators of regular PA practice will be assessed by using specific items specifically designed for the study because of lack of any reference scale.DiscussionThe study could demonstrate the impact of a self-management exercise program associated with spa therapy in the medium term by increasing PA level in people with OA. A benefit for ameliorating fears and beliefs and anxiety/depression and improving self-efficacy will also be analysed. The findings could offer new prospects while establishing best clinical practice guidelines for this population.Trial registrationClinicalTrials.gov NCT02598804 (November 5, 2015).Electronic supplementary materialThe online version of this article (10.1186/s12906-018-2339-x) contains supplementary material, which is available to authorized users.

Effect of Self-Management Program on Pain and Disability Index in Elderly Men with Osteoarthritis

“…Kao et al demonstrated that an SM program could improve the performance, health, and QOL of patients with KOA (46). The difference in the results of this study with other studies (12, 45, 46) was that the mentioned studies were conducted on male and female patients while the present study was carried out only among male patients.…”

“…Mirzaee et al also showed that the implementation of an SM program in four sessions of 70 minutes for four weeks resulted in the improvement of the performance of elderly patients with KOA (12). Gay et al showed that an SM program could improve the physical activity of male and female patients with OA aged 50 - 75 (45). Kao et al demonstrated that an SM program could improve the performance, health, and QOL of patients with KOA (46).…”

French validation of the Arthritis Self-Efficacy Scale and further psychometric properties exploration among 168 people with osteoarthritis

“…This study was an ancillary study of Geet one study (NCT02598804) 14 which was conducted by Clermont-Ferrand University Hospital, from July 2015 to January 2017. Written consent was obtained after being informed of the aim of the study and before inclusion in the study.…”

Self‐Report Measures of Physical Activity

“…A number of RCTs have used the IPAQ‐LF and the IPAQ‐SF to assess and classify the level of PA in a study population.…”

“…Although the IPAQ questionnaire has been used in several RCTs, it was predominately designed for observational or population‐based studies. Several observational studies in MSK populations have used the IPAQ‐LF and the IPAQ‐SF .…”