scholarly journals Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials

2018 ◽  
Vol 7 (5) ◽  
pp. e106 ◽  
Author(s):  
Daniel Pfirrmann ◽  
Nils Haller ◽  
Yvonne Huber ◽  
Patrick Jung ◽  
Klaus Lieb ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Esophageal Cancer ◽  
Liver Disease ◽  
Psychiatric Disorders ◽  
Process Evaluation ◽  
Exercise Intervention ◽  
Web Based

scholarly journals Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials (Preprint)

2017 ◽  
Author(s):  
Daniel Pfirrmann ◽  
Nils Haller ◽  
Yvonne Huber ◽  
Patrick Jung ◽  
Klaus Lieb ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Liver Disease ◽  
Activity Level ◽  
Daily Routine ◽  
Intervention Period ◽  
Web Based ◽  
Significant Change ◽  
Disease Specific

BACKGROUND In the primary and secondary prevention of civilization diseases, regular physical activity is recommended in international guidelines to improve disease-related symptoms, delay the progression of the disease, or to enhance postoperative outcomes. In the preoperative context, there has been a paradigm shift in favor of using preconditioning concepts before surgery. Web-based interventions seem an innovative and effective tool for delivering general information, individualized exercise recommendations, and peer support. OBJECTIVE Our first objective was to assess feasibility of our Web-based interventional concept and analyze similarities and differences in a sustained exercise implementation in different diseases. The second objective was to investigate the overall participants’ satisfaction with our Web-based concept. METHODS A total of 4 clinical trials are still being carried out, including patients with esophageal carcinoma scheduled for oncologic esophagectomy (internet-based perioperative exercise program, iPEP, study), nonalcoholic fatty liver disease (hepatic inflammation and physical performance in patients with nonalcoholic steatohepatitis, HELP, study), depression (exercise for depression, EXDEP, study), and cystic fibrosis (cystic fibrosis online mentoring for microbiome, exercise, and diet, COMMED, study). During the intervention period, the study population had access to the website with disease-specific content and a disease-specific discussion forum. All participants received weekly, individual tailored exercise recommendations from the sports therapist. The main outcome was the using behavior, which was obtained by investigating the log-in rate and duration. RESULTS A total of 20 participants (5 from each trial) were analyzed. During the intervention period, a regular contact and a consequent implementation of exercise prescription were easily achieved in all substudies. Across the 4 substudies, there was a significant decrease in log-in rates (P<.001) and log-in durations (P<.001) over time. A detailed view of the different studies shows a significant decrease in log-in rates and log-in durations in the HELP study (P=.004; P=.002) and iPEP study (P=.02; P=.001), whereas the EXDEP study (P=.58; P=.38) and COMMED study (P=.87; P=.56) showed no significant change over the 8-week intervention period. There was no significant change in physical activity within all studies (P=.31). Only in the HELP study, the physical activity level increased steadily over the period analyzed (P=.045). Overall, 17 participants (85%, 17/20) felt secure and were not scared of injury, with no major differences in the subtrials. CONCLUSIONS The universal use of the Web-based intervention appears to be applicable across the heterogonous collectives of our study patients with regard to age and disease. Although the development of physical activity shows only moderate improvements, flexible communication and tailored support could be easily integrated into patients’ daily routine. CLINICALTRIAL iPEP study: ClinicalTrials.gov NCT02478996; https://clinicaltrials.gov/ct2/show/NCT02478996 (Archived by WebCite at http://www.webcitation.org/6zL1UmHaW); HELP study: ClinicalTrials.gov NCT02526732; http://www.webcitation.org/6zJjX7d6K (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL); EXDEP study: ClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/6zJjj7FuA)

scholarly journals Move-It: A Cluster-Randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation

2019 ◽  
Vol 16 (18) ◽  
pp. 3451
Author(s):  
Holly Blake ◽  
Betsy Lai ◽  
Emil Coman ◽  
Jonathan Houdmont ◽  
Amanda Griffiths
Keyword(s):  
Physical Activity ◽  
Process Evaluation ◽  
Work Performance ◽  
Exercise Intervention ◽  
Office Workers ◽  
Control Group ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Cluster Randomised

We evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China, in a 2-arm cluster-randomised wait-list control trial (n = 282: intervention (INT) n = 196 and wait-list control (WLC) n = 86). Eligible clusters were two sites of a major organisation in China randomly allocated to each group (INT: Guangzhou; WLC: Beijing); eligible participants were site employees (n = 690). A theoretically informed digital workplace intervention (Move-It) involving a 10 min Qigong exercise session (video demonstration via website) was delivered twice a day at set break times during the working day for 12 consecutive weeks. Individual-level outcomes were assessed. Participants’ physical activity increased significantly from baseline to post-intervention similarly in both the intervention and the control group. There was a significantly smaller increase in weekday sitting hours in intervention than controls (by 4.66 h/week), and work performance increased only in the control group. Process evaluation (including six focus groups) was conducted using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. The intervention had wide reach and was successfully marketed to all employees with good uptake. The participatory approach increased perceived organisational support and enhanced adoption. The intervention was implemented broadly as planned. Qigong worksite exercise intervention can be successfully delivered to sedentary office workers in China using video and web-based platforms. It may increase physical activity and does not adversely affect perceived work performance. The study highlights the complexity of conducting health promotion research in real-world organisational settings.

scholarly journals Feasibility and implementation of a personalized, web-based exercise intervention for people with cystic fibrosis for 1 year

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Barlo Hillen ◽  
Perikles Simon ◽  
Sebastian Schlotter ◽  
Oliver Nitsche ◽  
Viola Bähner ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Lung Function ◽  
Exercise Capacity ◽  
Exercise Intervention ◽  
Daily Lives ◽  
Web Based ◽  
Exercise Participation ◽  
One Year ◽  
Test Distance ◽  
Activity Questionnaire

Abstract Background Regular participation in exercise is important for people with cystic fibrosis (CF). Therefore, we implemented a personalized, web-based exercise intervention over the course of one year for people with CF. The aims were to investigate the feasibility of the intervention and to evaluate changes in exercise participation, lung function, and exercise capacity. Methods In total, 11/17 participants [aged 12–52 years; FEV1%pred. 72.3 (SD: 17.3)] were included in the final data analysis. Every week, the participants received an individual training recommendation at the start and uploaded their training report on our website at the end of each week. The number of training minutes and sessions performed were analyzed over 13 four-week training sections. The participation in exercise (physical activity questionnaire), lung function and exercise capacity were assessed at baseline (T0), after 12 weeks (T1) and after 52 weeks (T2). Results A training duration of 178 min (SD: 75.5) and 3.3 (SD: 0.89) training sessions could be achieved weekly. In the first four-week training section, the participants performed 137.31 (SD: 95.7) minutes of training, with an increase of 42% in the third training section (195.01, SD: 134.99). Minutes of training reported on the questionnaire increased by 39.7% from T0 (179.38 min, SD: 120.9) to T1 (250.63 min, SD: 124.1) but decreased at T2 (166.88, SD: 155.4). There were slight decreases in lung function (FEV1 − 3.9%pred.; FVC − 1.9%pred.) and slight increases in exercise capacity (VO2peak + 1.5 ml/min/kg; six-minute-walk-test-distance + 26 m). Noticeably, five participants experienced deteriorations in their FEV1 of more than 5% but simultaneously experienced improvements in the parameters of exercise capacity of more than 5% throughout the year. Conclusions The web-based concept was feasible for the participants over the course of a year and supported exercise participation. The improvement in exercise capacity due to increased exercise participation over a prolonged period of time, despite a decrease in lung function, should be further investigated. Finally, if integrated into usual care, this approach could facilitate the prescription of regular personalized exercise and promote exercise participation in the daily lives of people with CF.

scholarly journals Web-Based Exercise as an Effective Complementary Treatment for Patients With Nonalcoholic Fatty Liver Disease: Intervention Study (Preprint)

2018 ◽  
Author(s):  
Daniel Pfirrmann ◽  
Yvonne Huber ◽  
Jörn Markus Schattenberg ◽  
Perikles Simon
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Cardiorespiratory Fitness ◽  
Body Fat ◽  
Fatty Liver Disease ◽  
Exercise Intervention ◽  
Complementary Treatment ◽  
Web Based ◽  
Nonalcoholic Fatty Liver ◽  
Face To Face

BACKGROUND Physical inactivity is a major risk factor for nonalcoholic fatty liver disease (NAFLD). Exercise-based prevention interventions for improving cardiorespiratory fitness are a recommended complementary treatment for NAFLD. Achievement of minimally effective physical activity to improve cardiorespiratory fitness among patients typically involves high personal and financial expenses in face-to-face settings. We designed an eHealth approach for patients with NAFLD to improve the cardiorespiratory fitness and report the first results of the HELP (Hepatic Inflammation and Physical Performance in Patients With NASH [nonalcoholic steatohepatitis]) study. OBJECTIVE We aimed to assess the effectiveness of an 8-week, tailored, Web-based exercise intervention for cardiorespiratory fitness improvement, expressed as peak oxygen uptake (peak volume of oxygen [VO2peak]), in patients with histologically confirmed NAFLD. METHODS In a 24-month period, 44 patients were enrolled into an 8-week, prospective, single-arm study with 12 weeks of follow-up. After a medical examination and performance diagnostics, a sports therapist introduced the patients to a Web-based platform for individualized training support. Regular individual patient feedback was provided to systematically adapt the weekly exercise schedule, which allowed us to monitor and ensure patient adherence to strength and endurance training and optimize the step-wise progressive exercise load. Exercise progression was based on an a priori algorithm that considered the subjective rate for both perceived exhaustion and general physical discomfort. The VO2peak was assessed at baseline and at the end of the study by spiroergometry. RESULTS A total of 43 patients completed the intervention with no adverse events. The VO2peak increased significantly by 2.4 mL/kg/min (8.8%; 95% confidence interval [CI]: 1.48-3.27; P<.001) accompanied by a reduction of 1.0 kg in a body weight (95% CI: 0.33-1.58; P=.004) and 1.3 kg in body fat mass (95% CI: 0.27-2.27; P=.01). In an exploratory analysis, step-wise logistic regression analysis revealed low body fat and VO2peak at baseline and the total minutes of endurance training during the intervention as main contributors to a positive change in VO2peak. Our predictive model indicated that the average patient with NAFLD needed 223 min for stabilization of VO2peak and 628 min for average improvement in VO2peak. However, in patients with a VO2peak approximately 20% higher than the average VO2peak, 628 min were only sufficient to stabilize the VO2peak and >40% reduction in the average fat mass would be required to achieve an average outcome. CONCLUSIONS This is the first study to show that patients with NAFLD can be effectively supported by a Web-based approach, which can increase the VO2peak to a similar extent as face-to-face interventions. Patients with low body fat and low VO2peak benefited the most from our intervention. In terms of future treatment strategies, NAFLD patients with high body fat may particularly benefit from body-fat reduction through a strict nutritional intervention, subsequently enabling a more effective exercise intervention. CLINICALTRIAL ClinicalTrials.gov NCT02526732; https://clinicaltrials.gov/ct2/show/NCT02526732 (Archived by WebCite at http://www.webcitation.org/74pXhXXfq) INTERNATIONAL REGISTERED REPOR RR2-10.2196/resprot.8607

scholarly journals Variation in treatment preferences of pulmonary exacerbations among Australian and New Zealand cystic fibrosis physicians

2021 ◽  
Vol 8 (1) ◽  
pp. e000956
Author(s):  
Grace Currie ◽  
Anna Tai ◽  
Tom Snelling ◽  
André Schultz
Keyword(s):  
Cystic Fibrosis ◽  
Clinical Trials ◽  
New Zealand ◽  
Treatment Options ◽  
Early Response ◽  
Treatment Preferences ◽  
Dornase Alfa ◽  
Clinical Scenarios ◽  
Professional Opinion ◽  
Pulmonary Exacerbations

BackgroundDespite advances in cystic fibrosis (CF) management and survival, the optimal treatment of pulmonary exacerbations remains unclear. Understanding the variability in treatment approaches among physicians might help prioritise clinical uncertainties to address through clinical trials.MethodsPhysicians from Australia and New Zealand who care for people with CF were invited to participate in a web survey of treatment preferences for CF pulmonary exacerbations. Six typical clinical scenarios were presented; three to paediatric and another three to adult physicians. For each scenario, physicians were asked to choose treatment options and provide reasons for their choices.ResultsForty-nine CF physicians (31 paediatric and 18 adult medicine) participated; more than half reported 10+ years of experience. There was considerable variation in primary antibiotic selection; none was preferred by more than half of respondents in any scenario. For secondary antibiotic therapy, respondents consistently preferred intravenous tobramycin and a third antibiotic was rarely prescribed, except in one scenario describing an adult patient. Hypertonic saline nebulisation and twice daily chest physiotherapy was preferred in most scenarios while dornase alfa use was more variable. Most CF physicians (>80%) preferred to change therapy if there was no early response. Professional opinion was the most common reason for antibiotic choice.ConclusionsVariation exists among CF physicians in their preferred choice of primary antibiotic and use of dornase alfa. These preferences are driven by professional opinion, possibly reflecting a lack of evidence to base policy recommendations. Evidence from high-quality clinical trials is needed to inform physician decision making.

scholarly journals Process evaluation of the ACTION programme: a strategy for implementing person‐centred communication in home care

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Tanja Gustafsson ◽  
Annelie J Sundler ◽  
Elisabeth Lindberg ◽  
Pernilla Karlsson ◽  
Hanna Maurin Söderholm
Keyword(s):  
Home Care ◽  
Process Evaluation ◽  
Organizational Support ◽  
Qualitative Data ◽  
Education Programme ◽  
Multiple Sources ◽  
Web Based ◽  
Action Programme ◽  
Web Based Education ◽  
The Web

Abstract Background There is currently a strong emphasis on person-centred care (PCC) and communication; however, little research has been conducted on how to implement person-centred communication in home care settings. Therefore, the ACTION (A person-centred CommunicaTION) programme, which is a web-based education programme focusing on person-centred communication developed for nurse assistants (NAs) providing home care for older persons, was implemented. This paper reports on the process evaluation conducted with the aim to describe and evaluate the implementation of the ACTION programme. Methods A descriptive design with a mixed method approach was used. Twenty-seven NAs from two units in Sweden were recruited, and 23 of them were offered the educational intervention. Quantitative and qualitative data were collected from multiple sources before, during and after the implementation. Quantitative data were used to analyse demographics, attendance and participation, while qualitative data were used to evaluate experiences of the implementation and contextual factors influencing the implementation. Results The evaluation showed a high degree of NA participation in the first five education modules, and a decrease in the three remaining modules. Overall, the NAs perceived the web format to be easy to use and appreciated the flexibility and accessibility. The content was described as important. Challenges included time constraints; the heavy workload; and a lack of interaction, space and equipment to complete the programme. Conclusions The results suggest that web-based education seems to be an appropriate strategy in home care settings; however, areas for improvement were identified. Our findings show that participants appreciated the web-based learning format in terms of accessibility and flexibility, as well as the face-to-face group discussions. The critical importance of organizational support and available resources are highlighted, such as management involvement and local facilitation. In addition, the findings report on the implementation challenges specific to the dynamic home care context. Trial registration This intervention was implemented with nursing assistants, and the evaluation only involved nursing staff. Patients were not part of this study. According to the ICMJE, registration was not necessary ().

scholarly journals DNA Methylation at ATP11A cg11702988 Is a Biomarker of Lung Disease Severity in Cystic Fibrosis: A Longitudinal Study

Genes ◽  
2021 ◽  
Vol 12 (3) ◽  
pp. 441
Author(s):  
Fanny Pineau ◽  
Davide Caimmi ◽  
Sylvie Taviaux ◽  
Maurane Reveil ◽  
Laura Brosseau ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Dna Methylation ◽  
Clinical Trials ◽  
Lung Disease ◽  
Disease Severity ◽  
Genome Wide ◽  
A Genome ◽  
Lung Disease Severity ◽  
Epigenetic Biomarker

Cystic fibrosis (CF) is a chronic genetic disease that mainly affects the respiratory and gastrointestinal systems. No curative treatments are available, but the follow-up in specialized centers has greatly improved the patient life expectancy. Robust biomarkers are required to monitor the disease, guide treatments, stratify patients, and provide outcome measures in clinical trials. In the present study, we outline a strategy to select putative DNA methylation biomarkers of lung disease severity in cystic fibrosis patients. In the discovery step, we selected seven potential biomarkers using a genome-wide DNA methylation dataset that we generated in nasal epithelial samples from the MethylCF cohort. In the replication step, we assessed the same biomarkers using sputum cell samples from the MethylBiomark cohort. Of interest, DNA methylation at the cg11702988 site (ATP11A gene) positively correlated with lung function and BMI, and negatively correlated with lung disease severity, P. aeruginosa chronic infection, and the number of exacerbations. These results were replicated in prospective sputum samples collected at four time points within an 18-month period and longitudinally. To conclude, (i) we identified a DNA methylation biomarker that correlates with CF severity, (ii) we provided a method to easily assess this biomarker, and (iii) we carried out the first longitudinal analysis of DNA methylation in CF patients. This new epigenetic biomarker could be used to stratify CF patients in clinical trials.

scholarly journals Overview of Non-Alcoholic Fatty Liver Disease (NAFLD) and the Role of Sugary Food Consumption and Other Dietary Components in Its Development

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1442
Author(s):  
Pau Vancells Lujan ◽  
Esther Viñas Esmel ◽  
Emilio Sacanella Meseguer
Keyword(s):  
Clinical Trials ◽  
Liver Disease ◽  
Critical Role ◽  
Dietary Treatment ◽  
Dietary Interventions ◽  
Lifestyle Modifications ◽  
Alcoholic Fatty Liver ◽  
Effective Form ◽  
Unhealthy Diet

NAFLD is the world’s most common chronic liver disease, and its increasing prevalence parallels the global rise in diabetes and obesity. It is characterised by fat accumulation in the liver evolving to non-alcoholic steatohepatitis (NASH), an inflammatory subtype that can lead to liver fibrosis and cirrhosis. Currently, there is no effective pharmacotherapeutic treatment for NAFLD. Treatment is therefore based on lifestyle modifications including changes to diet and exercise, although it is unclear what the most effective form of intervention is. The aim of this review, then, is to discuss the role of specific nutrients and the effects of different dietary interventions on NAFLD. It is well established that an unhealthy diet rich in calories, sugars, and saturated fats and low in polyunsaturated fatty acids, fibre, and micronutrients plays a critical role in the development and progression of this disease. However, few clinical trials have evaluated the effects of nutrition interventions on NAFLD. We, therefore, summarise what is currently known about the effects of macronutrients, foods, and dietary patterns on NAFLD prevention and treatment. Most current guidelines recommend low-calorie, plant-based diets, such as the Mediterranean diet, as the most effective dietary pattern to treat NAFLD. More clinical trials are required, however, to identify the best evidence-based dietary treatment approach.

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