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Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial.

ABSTRACT: Background:Fibromyalgia is characterized by chronic generalized pain, fatigue, sleep disorders and other symptoms. Physical exercise is recommended as the first choice of non-pharmacological therapy. Thus, the aim of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates exercises compared to aerobic exercises in the treatment of patients with fibromyalgia. Methods:In this randomized controlled trial with blinded assessor, 98 patients who meet the fibromyalgia classification criteria of the American College of Rheumatology 2010, aged between 20 and 75?years, and with pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale, will be randomly divided into Aerobic Group (aerobic exercises on treadmills or stationary bikes) and Pilates Group (modified Pilates exercises), and treated twice a week for eight weeks on the Center for Excellence in Clinical Research in Physical Therapy at Universidade Cidade de São Paulo, Brazil. The following outcomes will be evaluated by a blinded assessor at baseline, eight weeks, six months, and 12?months after randomization: impact of fibromyalgia assessed by the Fibromyalgia Impact Questionnaire, pain intensity by the Pain Numerical Rating Scale, kinesiophobia by the Tampa Scale of Kinesiophobia, specific disability by the Patient-Specific Functional Scale, functional capacity by the 6-min Walk Test, quality of sleep by the Pittsburgh Sleep Quality Index, and health-related quality of life by EQ-5D-3L and SF-6D questionnaires. Discussion:It is expected that the Pilates exercises will be more effective than aerobic exercises in improving clinical outcomes and that this improvement will be maintained over the medium to long term. This study aims to clarify whether the Pilates method can be incorporated into the clinical practice of physical therapists treating patients with fibromyalgia. The study will also provide information on which exercise will be most cost-effective, information that can be used by insurers and public health systems. Trial registration:This study was prospectively registered at the Clinical Trials Registry (NCT03050606) in February 2017.

SUBMITTER: Franco KFM

PROVIDER: S-EPMC6390629 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVES:To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN:Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING:Urban tertiary care academic hospital in the United States between March 2012 and September 2016. PARTICIPANTS:226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. INTERVENTIONS:Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. MAIN OUTCOME MEASURES:The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. RESULTS:FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. CONCLUSION:Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. TRIAL REGISTRATION:ClinicalTrials.gov NCT01420640.

Project description:BACKGROUND:Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. METHODS/DESIGN:A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ?21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. DISCUSSION:This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.

Project description:BackgroundChronic low back pain is potentially disabling for older adults, and exercise is considered the best treatment. The Pilates method and aerobic exercises have been proven to be effective in pain and function improvement in patients with low back pain, but evidence in the treatment of older adults with low back pain is scarce. Therefore, the objective of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercises in the treatment of older adults with chronic nonspecific low back pain.MethodsThis is a randomized controlled trial with blinded assessor, to be held in a physical therapy clinic in Sao Paulo, Brazil. Seventy four patients aged 65 to 85 years with chronic nonspecific pain will be randomized into Pilates Group (n = 37) with exercises based on the Pilates method and Aerobic Group (n = 37) with treadmill aerobic exercise. The primary outcomes will be pain intensity and general disability, assessed eight weeks after randomization. The secondary outcomes will be: pain intensity and general disability, assessed six months after randomization; and global perceived improvement, specific disability, dynamic balance, muscle strength (gluteus maximus, gluteus medius, and lateral hip rotators), and pressure pain threshold, assessed eight weeks and six months after randomization. Therapists and patients will not be blinded.DiscussionThis study has the potential to reduce pain and, consequently, improve balance and function of older adults with chronic low back pain with both therapies. However, Pilates may be more effective because the exercises are more targeted to the trunk stabilization muscles. The results of this study may provide valuable information on the effects of Pilates and aerobic exercise in older adults with chronic low back pain and contribute to a better selection of the treatment program according to the patient preference.Trial registrationClinicalTrials.gov NCT02729779 , April 6, 2016.

Project description:BACKGROUND:Women with fibromyalgia (FM) have 2.5 falls per year compared to the 0.5 falls in people without FM. This fact poses a significant health expense. Square Stepping Exercise (SSE) is a balance training system that has been shown to be effective in preventing falls in the elderly. However, there are neither studies in people with FM nor studies that apply SSE through video-conferencing (Tele-SSE). The objectives of this project are 1) to investigate the applicability, safety, decrease in the number of falls, and incremental cost-effectiveness ratio of prevention of falls program through Tele-SSE in women with FM, and 2) to study the transfer of obtained results to the public and private socio-health economy of Extremadura. Methods/Design: A randomized controlled trial with experimental (Tele-SSE) and control (usual treatment) groups will be carried out. The application of Tele-SSE will be performed for 12 months (three times per week) and one additional follow-up month after the intervention. A focus group including agents to identify key points to transfer the findings to the public and private sectors in Extremadura. One-hundred and eighteen women with FM will be recruited and randomly distributed into the two groups: Experimental (Tele-SSE; n = 59) and control group (Usual care; n = 59). Primary outcome measures will be: 1) Applicability; 2) safety; 3) annual number of falls; and 4) incremental cost-effectiveness ratio. Secondary outcomes will be: 1) Balance; 2) fear of falling; 3) socio-demographic and clinical information; 4) body composition; 5) physical fitness; 6) physical activity and sedentary behavior; 7) quality of life-related to health, mental health, and positive health; 8) pain; 9) disability level; 10) cognitive aspects; and 11) depressive symptoms. Regarding the focus group, the acceptability of the Tele-SSE will be evaluated in social-sanitary agents and will include Tele-SSE in their services offer. A statistical analysis will be carried out by treatment intention and protocol. In addition, a cost-effectiveness analysis from the perspective of the health system will be performed. DISCUSSION:This project aims to improve the efficiency and equity of physical therapy services based on tele-exercise in preventing falls in people with FM. Furthermore, orientations will be given in order to transfer the obtained findings into the social-sanitary system and market.

Project description:IntroductionPhysical exercises have been recommended to improve the overall well-being of patients with fibromyalgia, with the main objective of repairing the effects of lack of physical conditioning and of improving the symptoms, especially pain and fatigue. Although widely recommended and widely known, few studies support the use of Pilates as an effective method in improving the symptoms of the disease, comparing it with other well-founded exercise modalities. This protocol was developed to describe the design of a randomised controlled study with a blind evaluator that evaluates the effectiveness of mat Pilates, comparing it with aquatic aerobic exercises, in improving pain in women with fibromyalgia.MethodsSixty women aged 18-60 years with a diagnosis of fibromyalgia, with a score of between 3 and 8 points on the Visual Analogue Scale for pain, and who sign the clear and informed consent form will be recruited according to the inclusion criteria. They will be randomised into one of the two intervention groups: (1) Pilates, to perform an exercise programme based on mat Pilates; and (2) aquatic exercise, to participate in a programme of aerobic exercises in the swimming pool. The protocol will correspond to 12 weeks of treatment, with both groups performing the exercises with supervision twice a week. The primary outcome will be pain (Visual Analogue Scale for pain). The secondary outcomes are to include impact related to the disease, functional capacity, sleep quality and overall quality of life. The evaluations will be performed at three points: at baseline and after 6 weeks and 12 weeks of treatment.Ethics and disseminationThis protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 2.116.314). Data collection will begin after approval by the ethics committee. There will be prior contact with the women, at which time all the information about the study and the objectives will be presented, as well as resolution no 466/2012 of the National Health Council of Brazil for the year 2012, which provides guidelines and regulatory standards for research involving human beings. Participants must sign the informed consent form before the study begins.Trial registration numberNCT03149198.

Project description:Background and purposeSeveral studies have evaluated the effects of high-intensity aerobic training (HIAT) on pain severity and quality of life (QoL) among women with primary dysmenorrhea. However, to date, no studies have evaluated the effectiveness of HIAT on academic performance or absenteeism or examined the cost-effectiveness of HIAT relative to other treatments in women with primary dysmenorrhea. Furthermore, the mechanisms underlying aerobic exercise-induced analgesia in primary dysmenorrhea remain unclear. The objectives of this study are to: (1) evaluate the effects of HIAT on absenteeism and academic performance among university students, (2) identify the underlying mechanisms associated with aerobic exercise-induced analgesia in primary dysmenorrhea, and (3) determine the cost-effectiveness of HIAT compared with a wait-list control (WLC) group receiving usual care.MethodsA sequential, embedded, mixed-methods study design, including a crossover, randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. A total of 130 women aged 18-24 years will be randomised into either HIAT (n = 65) or wait-list control (n = 65) groups. Primary outcomes will include average pain intensity, absenteeism from university, and academic performance. Primary mediators will include salivary progesterone and prostaglandin F2α levels. Outcome and meditator variables will be assessed at baseline and post-treatment, at 12 and 28 weeks. An economic analysis will be conducted from the societal and healthcare perspective of Hong Kong. Semi-structured focus groups will be conducted at 32 weeks. Of the 130 participants included in the RCT, 70 will be included in the focus groups.Statistical analysisAll statistical analyses will be performed on an intention-to-treat basis, using SPSS (version 24). Preliminary analysis using an independent samples t-test and a two-sided, unpaired Student's t-test will be performed to exclude carryover effects and identify within-participant differences in outcome variables between the study periods, respectively. Treatment effects will be evaluated using analysis of variance via a mixed-effects model with fixed effects for intervention, period, and sequence. In all models, random effects will include the participants nested within the sequence as a sampling cluster. The mediation effects will be assessed using the Sobel test. The EQ-5D responses will be converted into utility scores to estimate the gain or loss of quality-adjusted life-years. Seemingly unrelated regression analyses will be used to estimate the total cost differences and effect differences. Qualitative data will be analysed using the process of thematic analysis.

Project description:IntroductionExercise is integral to health across the lifespan and important for people with chronic health conditions. A systematic review of exercise trials for chronic conditions reported suboptimal descriptions of the evaluated interventions and concluded that this hinders interpretation and replication. The aim of this project is to develop a standardised method for reporting essential exercise programme details being evaluated in clinical trials.Methods and analysisA modified Delphi technique will be used to gain consensus among international exercise experts. We will use three sequential rounds of anonymous online questionnaires to refine a standardised checklist. A draft checklist of potentially relevant items was developed based on the results of a systematic review of exercise systematic reviews. An international panel of experts was identified by exercise systematic review authorship, established international profile in exercise research and practice and by peer referral. In round 1, the international panel of experts will be asked to rate the importance of each draft item and provide additional suggestions for revisions or new items. Consensus will be considered reached if at least 70% of the panel strongly agree/disagree that an item should be included or excluded. Where agreement is not reached or there are suggestions for altered or new items, these will be taken to round 2 together with an aggregated summary of round 1 responses. Following the second round, a ranking of item importance will be made to rationalise the number of items. The final template will be distributed to panel members for approval.Ethics and disseminationEthics approval was received from The Cabrini Institute Ethics Committee, Melbourne, Australia (HREC 02-07-04-14). We plan to use a stepwise process to develop and refine a standardised and internationally agreed template for explicit reporting of exercise programmes. The template will be generalisable across all types of exercise interventions. The findings will be disseminated through peer-reviewed publications and conference presentations.

Project description:ObjectiveTo evaluate the effectiveness of Pilates exercise in people with chronic low back pain (CLBP) through a systematic review of randomised controlled trials (RCTs).Data sourcesA search for RCTs was undertaken using Medical Search Terms and synonyms for "Pilates" and "low back pain" within the maximal date range of 10 databases. Databases included the Cumulative Index to Nursing and Allied Health Literature; Cochrane Library; Medline; Physiotherapy Evidence Database; ProQuest: Health and Medical Complete, Nursing and Allied Health Source, Dissertation and Theses; Scopus; Sport Discus; Web of Science.Study selectionTwo independent reviewers were involved in the selection of evidence. To be included, relevant RCTs needed to be published in the English language. From 152 studies, 14 RCTs were included.Data extractionTwo independent reviewers appraised the methodological quality of RCTs using the McMaster Critical Review Form for Quantitative Studies. The author(s), year of publication, and details regarding participants, Pilates exercise, comparison treatments, and outcome measures, and findings, were then extracted.Data synthesisThe methodological quality of RCTs ranged from "poor" to "excellent". A meta-analysis of RCTs was not undertaken due to the heterogeneity of RCTs. Pilates exercise provided statistically significant improvements in pain and functional ability compared to usual care and physical activity between 4 and 15 weeks, but not at 24 weeks. There were no consistent statistically significant differences in improvements in pain and functional ability with Pilates exercise, massage therapy, or other forms of exercise at any time period.ConclusionsPilates exercise offers greater improvements in pain and functional ability compared to usual care and physical activity in the short term. Pilates exercise offers equivalent improvements to massage therapy and other forms of exercise. Future research should explore optimal Pilates exercise designs, and whether some people with CLBP may benefit from Pilates exercise more than others.

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Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial.

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