Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain

FIBROWALK is a multicomponent program including pain neuroscience education, therapeutic exercise, cognitive behavioral therapy and mindfulness training that has recently been found to be effective in patients with fibromyalgia (FM). This RCT started before the COVID-19 pandemic and was moved to a virtual format (i.e., online videos) when the lockdown was declared in Spain. This study is aimed to evaluate the efficacy of a virtual FIBROWALK compared to Treatment-As-Usual (TAU) in patients with FM during the first state of alarm in Spain. A total of 151 patients with FM were randomized into two study arms: FIBROWALK plus TAU vs. TAU alone. The primary outcome was functional impairment. Secondary outcomes were kinesiophobia, anxiety and depressive symptomatology, and physical functioning. Differences between groups at post-treatment assessment were analyzed using Intention-To-Treat (ITT) and completer approaches. Baseline differences between clinical responders and non-responders were also explored. Statistically significant improvements with small-to-moderate effect sizes were observed in FIBROWALK+TAU vs. TAU regarding functional impairment and most secondary outcomes. In our study, the NNT was 5, which was, albeit modestly, indicative of an efficacious intervention. The results of this proof-of-concept RCT preliminarily support the efficacy of virtual FIBROWALK in patients with FM during the Spanish COVID-19 lockdown.

Effects and Responsiveness of a Multicomponent Intervention on Body Composition, Physical Fitness and Leptin in Overweight/Obese Adolescents

Physical exercise reduces the biochemical markers of obesity, but the effects of multicomponent interventions on these markers should be explored. The present study aimed to elucidate how overweight/obese adolescents respond to a multicomponent program approach on body composition, physical fitness, and inflammatory markers, using a quasi-experimental study with 33 overweight/obesity adolescents (control group (CG) = 16; intervention group (IG) = 17). The intervention consisted of 24 weeks with physical exercises and nutritional and psychological guidance. Both groups were evaluated at the pre/post-intervention moments on body mass index (BMI); body fat (%Fat); waist circumference (WC); waist/hip ratio (WHR); waist-to-height ratio (WHtR), cardiorespiratory fitness (CRF); abdominal strength, flexibility; leptin; interleukin 6; interleukin 10; and tumor necrosis factor-alpha. Mixed-analysis of variance and generalized estimation equations were used for statistical analysis. There was an interaction effect between groups and time on %Fat (p = 0.002), WC (p = 0.023), WHR (p < 0.001), WHtR (p = 0.035), CRF (p = 0.050), and leptin (p = 0.026). Adolescents were classified as 82.4% responders for %Fat, 70.6% for WC, 88.2% for WHR, and 70.6% for CRF. Further, there was an association between changes in %Fat (p = 0.033), WC (p = 0.032), and WHR (p = 0.033) between responders and non-responders with CRF in the IG. There was a positive effect on body composition, physical fitness, and leptin. In addition, reductions in body composition parameters were explained by CRF improvements.

Does a Multicomponent Exercise Program Improve Physical Fitness in Older Adults? Findings From a 5-Year Longitudinal Study

The objective was to assess the physical fitness of older adults participating in a 5-year multicomponent exercise program. The sample consisted of 138 older adults aged 60–93 years (70.4 ± 7.8 years) evaluated with the Senior Fitness Test (muscle strength, flexibility, balance, and cardiorespiratory fitness). The multicomponent program was carried out between the months of March and November of each year. Data were analyzed using generalized estimating equations (factor year: Year 1, Year 2, Year 3, Year 4, and Year 5; factor time: pretest and posttest) with Bonferroni’s post hoc test. Participation in the multicomponent exercise program for 5 years (baseline pretest Year 1 and follow-up Year 5) improved lower and upper limb strength, lower limb flexibility, and balance and cardiorespiratory fitness, while upper limb flexibility was maintained. Year-by-year analysis revealed variable patterns for each fitness parameter. The results of this study show the potential benefits of implementing a long-term community-based exercise program.

Reducing the use of physical restraints in home care: development and feasibility testing of a multicomponent program to support the implementation of a guideline

Background A validated evidence-based guideline was developed to reduce physical restraint use in home care. However, the implementation of guidelines in home care is challenging. Therefore, this study aims to systematically develop and evaluate a multicomponent program for the implementation of the guideline for reducing the use of physical restraints in home care. Methods Intervention Mapping was used to develop a multicomponent program. This method contains six steps. Each step comprises several tasks towards the design, implementation and evaluation of an intervention; which is theory and evidence informed, as well as practical. To ensure that the multicomponent program would support the implementation of the guideline in home care, a feasibility study of 8 months was organized in one primary care district in Flanders, Belgium. A concurrent triangulation mixed methods design was used to evaluate the multicomponent program consisting of a knowledge test, focus groups and an online survey. Results The Social Cognitive Theory and the Theory of Planned Behavior are the foundations of the multicomponent program. Based on modeling, active learning, guided practice, belief selection and resistance to social pressure, eight practical applications were developed to operationalize these methods. The key components of the program are: the ambassadors for restraint-free home care (n = 15), the tutorials, the physical restraint checklist and the flyer. The results of the feasibility study show the necessity to select uniform terminology and definition for physical restraints, to involve all stakeholders from the beginning of the process, to take time for the implementation process, to select competent ambassadors and to collaborate with other home care providers. Conclusions The multicomponent program shows promising results. Prior to future use, further research needs to focus on the last two steps of Intervention Mapping (program implementation plan and developing an evaluation plan), to guide implementation on a larger scale and to formally evaluate the effectiveness of the multicomponent program.

Reducing the use of physical restraints in home care - Development and feasibility testing of a multicomponent program to support the implementation of a guideline

Background: A validated evidence-based guideline was developed to reduce physical restraint use in home care. However, the implementation of guidelines in home care is challenging. Therefore, this study aims to systematically develop and evaluate a multicomponent program for the implementation of the guideline for reducing the use of physical restraints in home care.Methods: Intervention Mapping was used to develop a multicomponent program. This method contains six steps. Each step comprises several tasks towards the design, implementation and evaluation of an intervention; which is theory and evidence informed, as well as practical. To ensure that the multicomponent program would support the implementation of the guideline in home care, a feasibility study of eight months was organized in one primary care district in Flanders, Belgium. A concurrent mixed methods design was used to evaluate the multicomponent program consisting of a knowledge test, focus groups and an online survey. Results: The Social Cognitive Theory and the Theory of Planned Behavior are the foundations of the multicomponent program. Based on modeling, active learning, guided practice, belief selection and resistance to social pressure, eight practical applications were developed to operationalize these methods. The key components of the program are: the ambassadors for restraint-free home care (n = 15), the tutorials, the physical restraint checklist and the flyer. The results of the feasibility study show the necessity to select uniform terminology and definition for physical restraints, to involve all stakeholders from the beginning of the process, to take time for the implementation process, to select competent ambassadors and to collaborate with other home care providers.Conclusions: The multicomponent program shows promising results. Prior to future use, further research needs to focus on the last two steps of Intervention Mapping (program implementation plan and developing an evaluation plan), to guide implementation on a larger scale and to formally evaluate the effectiveness of the multicomponent program.