Background Exercise interventions are often incompletely described in reports of clinical trials, hampering evaluation of results and replication and implementation into practice. Objective The aim of this study was to develop a standardized method for reporting exercise programs in clinical trials: the Consensus on Exercise Reporting Template (CERT). Design and Methods Using the EQUATOR Network's methodological framework, 137 exercise experts were invited to participate in a Delphi consensus study. A list of 41 items was identified from a meta-epidemiologic study of 73 systematic reviews of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item 7 or above. Three sequential rounds of anonymous online questionnaires and a Delphi workshop were used. Results There were 57 (response rate=42%), 54 (response rate=95%), and 49 (response rate=91%) respondents to rounds 1 through 3, respectively, from 11 countries and a range of disciplines. In round 1, 2 items were excluded; 24 items reached consensus for inclusion (8 items accepted in original format), and 16 items were revised in response to participant suggestions. Of 14 items in round 2, 3 were excluded, 11 reached consensus for inclusion (4 items accepted in original format), and 7 were reworded. Sixteen items were included in round 3, and all items reached greater than 70% consensus for inclusion. Limitations The views of included Delphi panelists may differ from those of experts who declined participation and may not fully represent the views of all exercise experts. Conclusions The CERT, a 16-item checklist developed by an international panel of exercise experts, is designed to improve the reporting of exercise programs in all evaluative study designs and contains 7 categories: materials, provider, delivery, location, dosage, tailoring, and compliance. The CERT will encourage transparency, improve trial interpretation and replication, and facilitate implementation of effective exercise interventions into practice.
BackgroundLow back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise.MethodsIn parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristics, and outcomes at short-term, moderate-term and long-term follow-up. We conducted descriptive analyses and one-stage IPD meta-analysis using multilevel mixed-effects regression of the overall treatment effect and prespecified potential treatment effect modifiers.ResultsWe received IPD for 27 trials (3514 participants). For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) −10.7 (−14.1 to –7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) −10.2 (−13.2 to –7.3)) at short-term follow-up. Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers—these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care. This study was limited by inconsistent availability and measurement of participant characteristics.ConclusionsThis study provides potentially useful information to help treat patients and design future studies of exercise interventions that are better matched to specific subgroups.Protocol publicationhttps://doi.org/10.1186/2046-4053-1-64
Consistent with prior evidence, a standardized mechanical assessment identified a large subgroup of LBP patients with a DP. Regardless of subjects' direction of preference, the response to contrasting exercise prescriptions was significantly different: exercises matching subjects' DP significantly and rapidly decreased pain and medication use and improved in all other outcomes. If repeatable, such subgroup validation has important implications for LBP management.
Poor outcomes from non-specific/unmatched exercise protocols appeared to reverse when patients with directional preference were given sub-group-matched, direction-specific exercises. Because of the limitations of our study design, replication with a control group and longer-term follow-up are required to validate the findings.
A large number of prognostic factors have been associated with recovery from an episode of back pain, and much emphasis has been placed on psychosocial prognostic factors. The large number of prognostic factors and the lack of comparative analysis of different factors make use of these difficult in clinical practice. The aim of this study was to evaluate the comparative usefulness of a range of factors to predict outcome using data from a randomized controlled trial (RCT) in which 312 patients with sub-acute to chronic back pain received a mechanical evaluation and were sub-grouped based on the presence or absence of directional preference (DP). Patients were then randomized to treatment that was matched or unmatched to that DP. Patients with a minimal reduction of 30% in Roland-Morris Disability Questionnaire (RMDQ) score were defined as the good outcome group. Seventeen baseline variables were entered into a step-wise logistic regression analysis for the ability to predict a good outcome. Of the patients, 84 met the good outcome criteria and had a mean RMDQ decrease of 58.2% (9.8 points) in 4 visits. Leg pain, work status, depression, pain location, chronicity, and treatment assignment were significant predictors of outcome in univariate analysis. Only leg bothersomeness rating and treatment assignment survived multivariate analysis. Subjects with DP/centralization who received matched treatment had a 7.8 times greater likelihood of a good outcome. Matching patients to their DP is a stronger predictor of outcome than a range of other biopsychosocial factors.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.