Original ResearchClinically meaningful changes in functional performance resulting from self-directed interventions in individuals with arthritis☆
Introduction
Arthritis is one of the most common chronic health conditions, affecting nearly 50 million adults in the United States in 2007–2009.1 The high prevalence of arthritis-associated disability,1 in addition to the billions of dollars attributed to arthritis,2 make it a major public health concern. Unfortunately, arthritis and its subsequent limitations are expected to continue to grow over the next 40 years due to the ageing population.3 Among the many consequences of arthritis are decreased range of motion and reduced physical functioning,4 likely leading to activity limitations. Limitations in activity due to arthritis are highly prevalent1 and are also expected to grow by 2030.3 Although functional limitations can vary significantly in how they are defined, studies have consistently shown a decline in function over time among individuals with arthritis.5, 6
The high and growing prevalence1 and disabling effects of arthritis7 have prompted a number of governmental agencies to formulate plans and strategies aimed at combating the condition and its negative consequences.4, 8, 9 For example, one objective of Healthy People 20209 is to reduce the proportion of adults with doctor-diagnosed arthritis who find it ‘very difficult’ to perform specific joint-related activities including walking a quarter of a mile; walking up 10 steps without resting; stooping, bending, or kneeling; and using fingers to grasp or handle small objectives.
Physical activity may be one means for slowing the progression and/or preventing functional declines among adults with arthritis. While a number of physical activity intervention studies have administered objective functional tests and examined change in function over time,10, 11, 12, 13, 14, 15 the meaningfulness of the changes has not been explored. Although examining whether a significant change in functional performance occurred is important, examining what that change means, and whether the change is meaningful, may be more valuable from a clinical standpoint.
STEPS to Health was a randomized, controlled trial that evaluated the effects of a 12-week, self-directed exercise program (First Step to Active Health®) for people with arthritis. The primary outcomes paper16 examined and reported changes in functional performance at 12 weeks and nine months. In general, results showed significant improvements in functional performance in both the intervention (exercise) and attention control (nutrition) groups at both follow-up time points. The purpose of this sub study was to further explore if the changes observed in functional performance were (1) clinically meaningful, (2) impacted the percentage of study participants classified as impaired, and (3) changed the percentage of participants at risk of losing functional independence.
Section snippets
Participant recruitment
A number of recruitment strategies were used, with the most common and most successful being emails to worksite listservs and newspaper advertisements. Because this study evaluated the effects of a public health intervention, a public health definition of arthritis, consistent with what is used in the National Health Interview Survey and the Behavioral Risk Factor Surveillance System,17 was used. Participants responding ‘yes’ to the question, ‘have you ever been told by a doctor or other health
Results
A more detailed description of the study flow has been previously reported.16 Of the 401 participants randomized, 312 (78%) had 12-week and/or 9-month follow-up data for at least one outcome. Those retained at either time point were more likely to have at least some college education than those lost at both follow-ups (P = 0.046). Demographic and health-related characteristics of the entire sample are shown in Table 2.
The percentage of participants with at least a minimally meaningful change
Discussion
The highly prevalent and debilitating nature of arthritis makes this condition an important target of public health interventions. Although management strategies differ across various types of arthritis, being physically active is appropriate for all types of arthritis, and may be very beneficial in preventing disability and loss of independence.17 This study responds to a substantial gap in the literature by examining if the changes observed in functional performance (1) were clinically
Acknowledgements
This study is registered with ClinicalTrials.gov: NCT01172327. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention or the Department of Health and Human Services. We wish to thank the study participants and the research staff and students for their important contributions.
Ethical approval
The study was approved by the University of South Carolina's Institutional Review Board. All
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Cited by (1)
Does land-based exercise-therapy improve physical activity in people with knee osteoarthritis? A systematic review with meta-analyses
2022, Osteoarthritis and CartilageCitation Excerpt :Only one trial compared exercise therapy to a sham intervention. Thirteen trials did not report or complete allocation concealment29,31,37,38,41,43,44,46,47,49,51,53,54, 12 trials did not report blinding of outcome assessment29,31,32,34,37,38,42,47,51–53,55, and 11 trials reported a large number of dropouts resulting in incomplete data30–32,35,42,43,46,51,52,56. No trials including a sham comparison measured physical activity at any timepoints.
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This work was done at the University of South Carolina, in Columbia, SC.