Research Article

Effect of Patient Education Program on Exercise Adherence and Clinical Outcomes in Individuals with Knee Osteoarthritis: A Randomized Controlled Trial

DOI:

10.3791/69372

⸱

February 24th, 2026

 ,  ,  ,  , 
1Faculty of Health Sciences, Physiotherapy Department, University of the Americas, 2Department of Physiotherapy, Faculty of Medicine, Health and Sports, Universidad Europea de Madrid, 3Logroño Physiotherapy Center

In This Article

Summary

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This protocol aims to evaluate the effect of a patient education program on exercise adherence and clinical outcomes in individuals with knee osteoarthritis using a randomized controlled design.

Abstract

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Knee osteoarthritis (KOA) is a leading cause of disability worldwide, significantly impairing motor function and quality of life. Exercise and weight management are key components of KOA treatment, with evidence showing that exercise therapy reduces pain, improves function, and enhances well-being. Given the importance of adherence to exercise regimens, this study evaluates the effect of a structured patient education program on exercise adherence and clinical outcomes in individuals with KOA. The research objective was "To evaluate whether patient education determines a greater degree of adherence to treatment in patients with knee osteoarthritis in the short and medium term." A prospective, single-blind randomized controlled trial with non-probabilistic sampling was conducted. Participants were randomized into two groups: (1) supervised exercise therapy plus a patient education program (intervention group) and (2) supervised exercise therapy alone (control group). Outcomes included pain (VAS), functionality (WOMAC), and physical activity (GPAQ), assessed at baseline, 4 weeks, 8 weeks, and 6 months. Both groups showed significant improvements in pain and function over time. The intervention group demonstrated greater short-term pain relief and functional improvement (p < 0.05). However, no statistically significant differences were observed between groups at 6 months (p > 0.05). Patient education enhances short-term outcomes in pain and function in individuals with KOA, but its effects diminish over time without ongoing support. Sustained benefits may require continuous engagement strategies.

Introduction

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Knee osteoarthritis (KOA) is one of the most common chronic diseases in the elderly population and represents a leading cause of functional limitation and disability worldwide1,2. Exercise therapy is considered a fundamental and first-line intervention for the management of symptomatic KOA, regardless of disease severity or degree of joint involvement3,4.

Exercise-based rehabilitation is strongly recommended by current clinical guidelines and constitutes the most widely prescribed non-pharmacological treatment for individuals with KOA5,6,7. Substantial evidence supports the effectiveness of exercise in reducing pain and disability, improving physical function, and enhancing quality of life in this population6,8,9,10. Both strength and endurance training programs, including home-based interventions, have demonstrated beneficial effects. When designing an exercise-based treatment plan, patient preferences, educational background, and access to healthcare resources should be considered to optimize outcomes11.

Despite the robust evidence supporting exercise therapy in KOA, ensuring long-term adherence remains a significant clinical challenge. Exercise adherence is influenced by multiple factors, including psychological, social, and behavioral components, highlighting the importance of a biopsychosocial approach to care. Tailoring interventions to individual needs and incorporating patient education are considered essential strategies for promoting sustained engagement in exercise programs12,13,14.

The growing aging population, together with the increasing prevalence of obesity, is expected to substantially raise the number of individuals affected by KOA in the coming decades15. Given the chronic and progressive nature of the condition, this trend is likely to result in increased healthcare utilization and substantial social and economic costs16. Improving adherence to conservative interventions such as exercise therapy may therefore play a key role in mitigating disease burden and optimizing resource use.

Accurate assessment of exercise adherence is essential for evaluating the effectiveness of rehabilitation interventions. Mahmood et al. suggest that adherence should be measured using a combination of subjective instruments, such as the Exercise Adherence Rating Scale (EARS), the Global Physical Activity Questionnaire (GPAQ), and the Sluijs Scale, alongside objective methods, to reduce bias and improve measurement accuracy, given the absence of a single gold standard17.

In this context, patient education has been proposed as a potential strategy to enhance motivation, adherence to exercise programs, and subsequent clinical outcomes. Therefore, the aim of this study was to evaluate whether the addition of a structured patient education program to supervised exercise therapy improves exercise adherence and clinical outcomes in individuals with knee osteoarthritis in the short and medium term.

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Protocol

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The study was approved by the Research Bioethics Committee (reference number: 2019-169E) and was registered on ClinicalTrials.gov (Identifier: CEISH-USFQ 2019-169E). All procedures were conducted in accordance with the ethical principles of the Declaration of Helsinki and the applicable guidelines for research involving human subjects18. All participants received detailed verbal and written information about the study and provided written informed consent prior to participation.

1. Study design

The study was designed as a randomized, single-blind, prospective, analytical clinical trial with non-probability sampling and two parallel groups (case and control), and was conducted in accordance with the CONSORT guidelines.

2. Sample size calculation

Since the population size was unknown, the sampling formula of proportions was applied to calculate the sample size; this was calculated using G*Power software (v3.1.9.2), assuming an alpha error of 0.05, a statistical power of 0.80, and a medium effect size (f = 0.25; partial eta squared = 0.06). To accommodate a potential dropout rate of 15%, the required total sample was adjusted to 50 participants, with 25 allocated per group.

3. Participants

The study was conducted at Logroño's Physiotherapy, a physical and sports rehabilitation center located in the Metropolitan District of Quito. A blinded evaluator was responsible for verifying that all participants met the study selection criteria.

Participant recruitment was carried out using multiple strategies, including social media advertising, collaboration with orthopedic physicians from public and private hospitals in Quito, and the distribution of informational flyers at the clinic and other rehabilitation centers.

  1. Inclusion criteria were
    Adults over 45 years of age diagnosed with knee osteoarthritis (KOA), either unilateral or bilateral, classified as grade II or III according to the Kellgren and Lawrence radiological classification19, and reporting knee pain intensity between 30 mm and 80 mm on the visual analog scale20.
  2. Exclusion criteria included
    Unstable cardiac conditions, fibromyalgia, inability to walk independently, prior knee or hip arthroplasty, neurological disorders, medical contraindications to physical activity, polyarthralgia (affecting more than three joints), and lower limb trauma within the three months preceding the study21. Additionally, individuals who had received intra-articular knee injections of corticosteroids or hyaluronic acid within 3-6 months prior to enrollment, as well as those undergoing continuous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids prescribed by a physician, were excluded20,21.

4. Randomization

Participant allocation to the study groups was performed using GraphPad software²².

5. Procedure

The intervention period lasted 8 weeks, with a frequency of three sessions per week, based on evidence supporting the effectiveness of similar exercise protocols in individuals with knee osteoarthritis 23. The control group received a previously established lower limb strengthening exercise protocol. The experimental group followed the same exercise protocol, with the addition of one weekly patient education session.

All exercise sessions were supervised by a physiotherapist trained in therapeutic exercise, who was responsible for correcting technique and adjusting exercises when necessary to manage symptoms. Each physiotherapy session had a duration of 60 min. A blinded physiotherapist, not involved in the intervention, performed all outcome evaluations and measurements.

Pain intensity was assessed using the Visual Analog Scale (VAS), pressure pain sensitivity was evaluated through pressure algometry, functional status was measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and physical activity levels were assessed using the Global Physical Activity Questionnaire (GPAQ). Assessments were conducted at baseline (pre-intervention), after four weeks of treatment, at the end of the intervention period (8 weeks), and at a 6-month follow-up. All evaluations were performed at the same clinical facility where the intervention took place.

To minimize participant attrition, a member of the research staff contacted each participant by telephone one day prior to every scheduled session.

6. Intervention

Participants in the control group (CG) performed a lower limb strengthening exercise program consisting of three sets of ten repetitions for each exercise, with a 2 min rest interval between sets. The training frequency was three sessions per week over an 8-week period. Each session included five exercises: knee extension, partial wall squat, standing hip abduction, hamstring curl, and calf raises24. During the first week, exercises were performed without an external load. From the second week onward, load progression was individually adjusted by the physiotherapist according to each participant's strength and functional capacity. All exercises were performed bilaterally, starting with the limb experiencing less pain. Each session began with a 10-min warm-up on a stationary bicycle without resistance25.

The experimental group (EG) followed the same exercise protocol as the control group, with the addition of one weekly individualized patient education session lasting between 20-30 min. During these sessions, the physiotherapist addressed participants' questions and concerns related to knee osteoarthritis and the prescribed exercise program. Educational sessions incorporated visual and audiovisual materials from the My Knee Exercises program, which is freely available to patients and healthcare professionals26.

The educational intervention was not standardized using a predefined checklist. Instead, it followed the structure and content proposed in the official online program without formal modifications. The only standardized parameter was session duration (20-30 min per participant). The educational approach was individualized and adapted to each participant's beliefs, expectations, doubts, and potential fears related to the therapeutic process. This decision was based on the personalized nature of patient education and the contextual constraints imposed by the COVID-19 pandemic, during which efforts were made to limit in-person exposure time and prioritize participant safety.

7. Outcome measurements

Outcome assessments were conducted using questionnaires and measurement tools validated for Spanish-speaking populations. All evaluations were performed by the same blinded physiotherapist at four time points: baseline (prior to the intervention), at the fourth week of treatment, at the end of the intervention period (8 weeks), and at a 6-month follow-up.

Pain intensity was assessed using the Visual Analog Scale (VAS), a widely used and reliable tool for monitoring pain severity in individuals with knee osteoarthritis. Pressure pain sensitivity was additionally evaluated using a pressure algometer. Functional status was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a validated instrument for knee osteoarthritis that evaluates pain (5 items), stiffness (2 items), and physical function (17 items). Participants rated their symptoms experienced over the previous 72 h, and domain scores were calculated by averaging the corresponding item scores.

Exercise adherence was indirectly assessed through self-reported physical activity levels using the Global Physical Activity Questionnaire (GPAQ), developed by the World Health Organization. The GPAQ evaluates physical activity across three domains, occupational activity, active transportation, and leisure-time physical activity, and includes an assessment of sedentary behavior. The questionnaire collects information on the frequency, duration, and intensity of physical activity performed during a typical week.

The assessment of exercise adherence represents a methodological challenge, as no single gold standard measurement exists. Mahmood et al. recommend combining subjective and objective methods to improve the accuracy of adherence assessment27. However, given the contextual limitations imposed by the COVID-19 pandemic during the period in which this study was conducted, the GPAQ was selected as the primary measure of adherence. This decision was supported by previous evidence indicating that the GPAQ is suitable for evaluating changes in physical activity related to educational interventions in individuals with knee osteoarthritis28, is appropriate for remote and self-administered assessment, captures moderate-to-vigorous leisure-time physical activity, and has demonstrated validity and reliability in adults over 50 years of age, including Spanish-speaking populations and Latin American settings29.

8. Statistical analysis

Statistical analyses were performed using SPSS software (version 29.0 for Windows). Data distribution was assessed using the Shapiro-Wilk test in combination with visual inspection of Q-Q plots. Homogeneity of variances was evaluated using Levene's test, and sphericity was examined with Mauchly's test.

As several variables did not meet the assumptions of normality and homogeneity, non-parametric tests were applied when appropriate. Specifically, Friedman and Wilcoxon signed-rank tests were used to analyze changes in exercise adherence across time. For repeated measures analyses of WOMAC outcomes, the Greenhouse-Geisser correction was applied when the assumption of sphericity was violated.

To evaluate changes in pain intensity (VAS), functional status (WOMAC), and physical activity levels over time and between groups, a two-way mixed analysis of variance (ANOVA) with a 2 × 2 design was conducted. This model included time as a within-subject factor and group as a between-subject factor, allowing for the assessment of main effects and time × group interactions. When significant effects were identified, post hoc pairwise comparisons were performed using Bonferroni correction to adjust for multiple comparisons.

Effect sizes were calculated using partial eta squared (η2p), with values of 0.01, 0.06, and 0.14 interpreted as small, medium, and large effects, respectively. All statistical analyses were conducted using a 95% confidence level, and statistical significance was set at p < 0.05.

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Results

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Baseline characteristics
A total of 49 participants with knee osteoarthritis (KOA), aged between 45-75 years, were included in the study. The majority of participants were female (77%). Participants were stratified into three age groups: 45-55 years (n = 14), 56-65 years (n = 30), and 66-75 years (n = 5).

Most participants presented with moderate (61.5%) or moderate-to-severe KOA (38.5%) according to the Kellgren and Lawrence grading system. Moderate KOA was more prevalent...

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Discussion

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The present study examined the effects of combining supervised therapeutic exercise with structured patient education in individuals with knee osteoarthritis (KOA). The findings indicate that this combined intervention produced greater short-term improvements in pain and functional outcomes compared to exercise alone, with a tendency toward better maintenance of exercise adherence at six months. Although not all between-group differences reached statistical significance, the experimental group consistently demonstrated m...

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Disclosures

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The authors declare no conflicts of interest.

Acknowledgements

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The authors would like to thank all participants for their time and commitment to this study. No external funding was received for this research.

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Materials

List of materials used in this article
NameCompanyCatalog NumberComments
Exercise matMarath onhttps://www.marathon.store/ec/productos/deporte/h ombre/gimnasio/wod-shop-mat-de- yoga/p/bt_SU_10695473Floor- based exercises
GPAQ questionnaireWorld Health Organiz ation (WHO)https://www.who.int/es/publications/m/item/global- physical-activity-questionnaireSpanish version
GraphPad PrismGraphP ad Softwarev9.0Randomization
Knee extension machineAthleticT1002. (Linea selection)Resistan ce training with adjustable weight
Pressure algometerWagner InstrumentsFPXPain assessment
Resistance bands (light, medium, strong)TheraB andhttps://www.ortopedicosfuturo.com.ec/banda-elstica- clx-azul-thera-band- 22402674/p?srsltid=AfmBOopFoBjb5NfdGVpF8lLh
vO0 PKeJJwGzNynlB27iRPK3dP1_a
bmzV		Progressive resistance during exercises
SPSS StatisticsIBMVersion 29Statistical analysis
Stationary bicycleAthletic1800BVP
Visual Analog Scale (VAS)—https://methods.sagepub.com/ency/edvol/sage- encyclopedia-of-educational-research-measurement- evaluation/chpt/visual-analog-scales#_Printed scale
Visual and audiovisual educational materials (My Knee Exercises program)My Knee Exercises programhttps://mykneeexercise.org.au/my-knee-education/Patient education sessions (experimental group)
WOMAC questio nnaire—https://www.ser.es/wp- content/uploads/2016/07/WOMAC_cuestionario.pdfSpanish validated version
            Used for warm-up

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Tags

Knee OsteoarthritisExercise AdherencePatient EducationExercise TherapyRandomized Controlled TrialPain ReductionFunctional ImprovementPhysical ActivityShort Term OutcomesClinical Outcomes

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