The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis (OA): a knowledge translation (KT) randomized controlled trial (RCT): Part I: The Uptake of the Ottawa Panel clinical practice guidelines (CPGs)

A major issue in health research today is finding effective and efficient ways to exchange knowledge between researchers, clinicians and the general public. Potential benefits to health which could be accrued through the application of research findings are not realized due to challenges in research uptake and knowledge translation [10]. KT is defined by Estabrooks et al. [11] as “the process by which specific research-based knowledge (science) is implemented in practice.”

The available evidence suggests that with an effective KT strategy, uptake of evidence-based clinical practice guidelines (EBCPGs) can be effective in improving patient health outcomes [12].

The promotion of physical activity (PA) is a priority for health organizations serving the general population [13, 14] and is highly recommended for subgroups affected by chronic diseases [15‐19]. Community-based PA combined with a behavioural modification and self-management interventions can reduce the risk of disability and negative consequences of inactivity related to OA [20, 21]. The challenge is to develop PA programs that will encourage OA patients to initiate and maintain improvements in exercise behaviour over a long-term period [22]. The available evidence suggests that with an effective KT strategy, uptake of evidence-based clinical practice guidelines (CPGs) can be effective in improving patient health outcomes [12].

Multifaceted interventions combining more than one KT strategy have tended to be more effective than using a single KT strategy alone [23, 24] and have shown to have the greatest impact on CPG adherence and PA performance [25]. Behavioural interventions have been used for other chronic conditions to improve long-term adherence and maintenance of PA regimens with varying success. The efficacy of different behavioural interventions including patient education, health counselling, goal setting, and social/peer support, delivered separately and or in combination, have been examined in the management of arthritis [26‐31].

This single blind RCT, funded by the Canadian institutes of Health Research, used a parallel group design (1:1:1). This community-based study was approved by the University of Ottawa Research Ethics Board and the City of Ottawa Public Health Research Ethics Board. This study implemented one of the Ottawa Panel CPG recommendations related to a supervised community-based aerobic walking programs (SCAWPs) among individuals with mild to moderate OA of the knee [33‐35].

In order to facilitate an understanding of the KT process, Graham et al. developed a conceptual framework entitled “the Knowledge-To-Action Cycle” (Figure 1) which provides an approach which combines commonalities from various planned-action theories [8, 9]. This framework was used to guide the development of the three KT strategies used in this RCT (Additional file 1). The framework demonstrates the dynamic process of knowledge creation and application [9]. Knowledge creation consists of three phases: knowledge inquiry, knowledge synthesis, and knowledge tools/products. The knowledge creation cycle of the framework demonstrates how knowledge is refined through each phase to provide useful information for end users. The action cycle of the framework consists of seven phases which may occur sequentially or simultaneously: 1) Identify the Knowledge-To-Action Cycle gaps; 2) Adapt Knowledge to local context; 3) Assess barriers to Knowledge Use; 4) Select, Tailor, Implement Interventions; 5) Monitor Knowledge Use; 6) Evaluate outcomes; and 7) Sustained Knowledge Use. For part I, the emphasis was placed on the “Evaluate outcomes (KT outcomes)” phase as participants’ knowledge uptake was measured as adherence to the effective walking program for OA and attitude/behaviour change (self-efficacy and confidence) after participating in the SCAWP.

The hypothesis was that the additional behavioural approach of the multifaceted KT intervention would: 1) increase short and long term adherence to the SCAWP; 2) reduce the drop-out rate; 3) influence behaviour change by improving self-efficacy, confidence, QoL and other clinical outcomes.

A total of 222 adults with knee OA were recruited. Participants were eligible to participate in the study if he/she 1) had a confirmed diagnosis with mild to moderate unilateral or bilateral OA according to the American College of Rheumatology clinical and radiographic/magnetic resonance imagery criteria; 2) reported pain for at least 3 months; 3) expected his/her medication to change during the study period; 4) demonstrated an ability to ambulate for a minimum of 20 minutes, at their own pace with minimal reports of pain (≤ 3 out of 10 on a visual analogue pain rating scale) [36]; 4) were able to be treated as an out-patient; and 5) were available three times a week over a period of 12 months. Potential study subjects were excluded if they had: 1) Participated in regular physical or aerobic sports ≥ 2 times per week for more than 20 minutes per session during the previous 6 months; 2) severe OA of the knee or other weight bearing joints of the lower extremity; 3) no written consent from their physician to participate in the study; 4) pain at rest or at night; 5) received rehabilitation treatment, corticosteroids injection, or any other pain-related treatment besides medication for arthritis within the last 12 months; 6) uncontrolled hypertension (Systolic blood pressure >160 mm Hg confirmed by the screening initial VO2 max test at the Ottawa Heart Institute) 7) other illnesses, such as rheumatoid arthritis (judged by the patient or study physician to make participation in this study inadvisable); 8) significant cognitive deficit resulting in an inability to understand or comply with instructions; 9) surgery planned in the next year; 10) Intention to move away from Ottawa region in the next year; 11) an inability to communicate in English or French; or 12) an unwillingness to sign informed consent. The study coordinator assessed the inclusion/exclusion criteria of all potential participants by telephone. At the first visit, written informed consent was obtained if the patient met all inclusion criteria.

Participants were randomly assigned to one of the three KT intervention groups using central randomization [37] and computer generated numbers [38]: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the SCAWP with a behavioural intervention and an educational pamphlet on the benefits of walking for OA; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the SCAWP intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. All 3 groups were provided with pedometers and log books to be completed to measure physical performance (walking in minutes) and additional PA aside from the walking sessions (Table 1). The KT strategies were implemented over a 12-month duration and participants were assessed for additional 6 months (15 and 18-month follow-up assessments).

Following the successful randomization process, wherein no statistical difference was found between the three groups (with the exception of the “physical role” category of the SF-36: part II) (Tables 2, 3, 4, 5), research staff and evaluators were blinded to the treatment allocation. An independent evaluator was blinded to assess outcome measures. Due to the nature of the physical intervention, it was not practical to blind the study participants and PA specialists supervising the aerobic walking program [39].

Participants were assessed by an independent evaluator at baseline and at each 3 month interval (months 3, 6, 9, 12) during the intervention period. Participants were then assessed at 3 and 6 months post-intervention during the follow-up period (15 and 18-months). Participants were asked to complete a collection of validated questionnaires as well as perform physical tests at each assessment.

The effectiveness of blinding the evaluator to treatment allocation was assessed through a questionnaire where she was asked to identify which group each participant belonged to. The blinding rate of the evaluator was high (98%).

From baseline to 12 months, the adherence rates were expressed as percentages of adherence among walkers who did not drop out and were reported as means (+/−standard deviation) for each time period between groups (Table 4). Statistically significant results for short-term adherence rates favoured participants in the WB group (80.2%) compared to the self-directed (C) group (65.2%) (p<0.012) after 3 months. For long term adherence (6 to 12 months), the WB group demonstrated superior adherence rates throughout each period compared to the other two groups, but results did not reach statistical significance. No statistical significance (p> 0.05) was observed for the total adherence rates between WB vs. W, W vs. C, and WB vs. C.

During the 12-month intervention period, the dropout rates were 43.1% for the W group, 40.6% for the WB group and 49.3% for the self-directed (C) group. From baseline to 18 months, the dropout rates were 44.3% for the W group; 40.6% for the WB group and 52.1% for the self-directed (C) group (Figure 2 and Additional files 3 &4). The dropout rates were lower for the WB group at 12-months (36.2%) and 18-months (39.1%) compared to the W group (40.5% and 44.3%) and the self-directed (C) group (40.5% and 51.3%). The W and self-directed (C) groups had the highest dropout rates (40.5%) at 12 months while the self-directed (C) group had the highest at 18 months (52.1%).

After the 12 month intervention phase, no differences were found between the 3 comparative groups for any of the items on the Stanford scale (Table 5). Moreover, variables related to coping with symptoms and confidence were higher among the WB group compared to the other two groups.

At 18-months, statistically significant differences in scores between the WB and W groups revealed that the W group demonstrated an improved mean for the “confidence about doing things” variable (p=0.041). The self-directed group (C) demonstrated the highest mean “confidence about doing things” score 8.015± 1.476 (p=0.040) as it increased by 0.157 (p=0.048) when compared to baseline. The self-directed group (C) demonstrated the highest mean score 8.015± 1.476 (p=0.040).

There were no statistically significant results among the three groups at 12 months. These results concur with a similar study [53] and are normal in the context of a KT study which implemented an already proven effective walking program [33‐35]. However, at 18-months, there were statistically significant results which favoured the self-directed group (C). One reason explaining why participants in the self-directed group (C) had higher confidence and self-efficacy scores may be due to the fact that since these individuals were not supervised, they may have been more independent, self-controlled, self-confident, and self-motivated. Participants in this group may have also had the opportunity, over the 12-month period, to develop confidence and self-efficacy skills compared to the two supervised groups during the unsupervised follow-up phase.

The variable “confidence about doing things” decreased after 12 months for the WB group. Given the high amount of PA demonstrated by the WB group at 12 months, we were surprised with this result. On the other hand, at 18 months, statistically significant results favoured the W group compared to WB group for the variables “confidence about doing things”. Again, these results about confidence were unexpected given that the WB group performed higher amounts of PA.

Exercise therapists, pedometers, logbooks and social support from walking club members (Table 1) assisted participants who had difficulties with activity adherence and maintenance [57]. Regular professional contact was recognised as the significant motivational factor for adherence to the supported walking program during the RCT [43]. Social support has been reported to be more successful in engaging participants in PA programs compared to programs which only provided written educational material [58, 59]. The combination of using pedometers and goal-setting has been recognised as an effective KT tool for increasing PA [31, 60‐62]. However, despite the short-term effectiveness of pedometers and goal-setting, the success of these tools diminished over time. Other KT strategies are recommended to facilitate sustainability [62].

Barriers related to the implementation of SCAWP were identified and addressed to improve adherence for older individuals [57]. Acceptability (preferences, tolerance and accessibility) should be considered to promote PA adherence and to overcome associated barriers [63]. The most common barriers identified by participants with OA are perceptions about illness and recovery, transportation difficulties, family commitments and inconvenient timing [64]. Time commitment is also recognised as a significant barrier [55]. Additional barriers such as weather conditions including snow storms, freezing rain and humidity, a 3-month bus strike, and health problems of participants’ partners may have contributed to study adherence.

Adherence is influenced by participant’s preference of intervention [65‐70]. Unfortunately, with this study being a RCT, taking participants’ preference into consideration was not possible due to the randomization procedure. This being said, randomisation may have contributed to higher dropout rates. The purpose of this KT study was to implement a scientifically proven effective walking program for OA [33‐35].

Short term research suggests that self-management interventions [16, 18], telephone counselling [22, 46, 71‐73], peer support [13, 74‐76] and PA education [18, 22, 27, 41, 77] are effective behavioural strategies for improving self-efficacy. The long-term multifaceted behavioural strategy used in this study did not concur with the previous studies, as participants in the self-directed group (C group) were provided information and education on the benefits of PA.

Methods of measurement for adherence for the W and WB groups were different than the self-directed (C) group. Observed attendance was recorded on site for each walking session for the W and WB groups by exercise therapists while adherence could only be measured in the self-directed group (C) using completed logbooks. The self-reporting of PA, which is commonly overstated, may have been subject to potential information bias.

Selection bias may have occurred as our study population included individuals with mild to moderate OA, with a confirmed X-ray report. In addition, some participants were retired while some were still employed. Since participants were provided monetary compensation for their participation in the study, one may argue the generalizability of the results.

This KT RCT aimed to identify the best multifaceted strategy to implement a proven effective walking program for OA of the knee among older individuals. The epidemic public health problem of OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs as well as at home with minimal support. More studies are needed to improve the long-term walking adherence or knowledge uptake on SCAWP among participants with OA. Particular attention should focus on patients’ characteristics and preferences.