scholarly journals Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months

PeerJ ◽  
2020 ◽  
Vol 8 ◽  
pp. e9303
Author(s):  
Navina N. Nasseri ◽  
Eghbal Ghezelbash ◽  
Yuyang Zhai ◽  
Stefan Patra ◽  
Karin Riemann-Lorenz ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Medical Treatment ◽  
Pilot Trial ◽  
Intervention Group ◽  
Activity Monitor ◽  
Smartphone App ◽  
Control Group ◽  
Active Lifestyle ◽  
Randomized Controlled

Background People with chronic progressive multiple sclerosis (CPMS) have limited options in medical treatment. Enhancing physical activity (PA) might promote neuroregeneration in multiple sclerosis (MS) and positively influence disability, thus providing an alternative to medical treatment. Previous studies indicate that evidence-based patient information (EBPI) is essential for inducing behavioral change, e.g. enhancing PA. Objective To investigate feasibility of a smartphone app providing EBPI about the benefit of PA and a simple activity feedback to enhance PA in people with CPMS in a pilot randomized controlled trial over 3 months. Methods Thirty-eight people with CPMS (mean age 51 years, median Expanded Disability Status Scale 4.0) were 1:1 randomized into either a control group (n = 20) or an intervention group (n = 18). The intervention group received access to a multimedia EBPI app including activity feedback, texts, figures and videos. In the control group, participants received a leaflet with unspecific information about exercising in general. The EPBI itself was designed based on a systematic review. At baseline and after 3 months, all participants underwent clinical performance tests, filled in questionnaires and received an activity monitor (Actigraph®) for 7 days. The primary endpoint was the rate of responders defined as participants with a 20% increase of physical acitivity (time of moderate or vigiorous PA—MVPA) or 20% increase of the number of steps, both assessed with the activity monitor. As secondary endpoints, we compared accelerometry, performance and questionnaires adjusted for baseline measurments between the groups (ANCOVA). Moreover, we used questionnaires to compare knowledge about exercise (activity requiring physical effort, carried out to improve or improve health and fitness) in MS, usability of the app in general and motivation towards a more active lifestyle after 3 months in both groups. Results The groups showed significant differences in disease duration and PA according to the Godin–Leisure Time Exercise Questionnaire at baseline. After 3 months, we detected no difference in the rate of responders, which was an overall 22%. However, MVPA significantly increased in both groups (p < 0.001) and the intervention group tended to have a higher motivation towards a more active lifestyle (Cohens D = 0.7, p = 0.09) as measured by the questionnaire. Reponses also showed, that participants appreciated the app but claimed a lack of interactivity as a short-coming. Conclusion Just providing information in a multimedia smartphone app did not enhance physical activitiy more than a simple leaflet in this small pilot trial in CPMS. However, the group of app users tended to have a higher motivation towards a more active lifestyle. Overall, the concept of a smartphone app to support an active lifestyle in MS is highly appreciated by participants.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

The association of innate and acquired aerobic capacity with resilience in healthy adults: Protocol for an eight-week randomized controlled web-based physical exercise intervention study (Preprint)

2021 ◽  
Author(s):  
David Tobias Ochmann ◽  
Keito F A Philippi ◽  
Peter Zeier ◽  
Magdalena Sandner ◽  
Barlo Hillen ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Exercise ◽  
Aerobic Capacity ◽  
Exercise Intervention ◽  
Intervention Group ◽  
Control Group ◽  
Active Lifestyle ◽  
Web Based ◽  
Before And After ◽  
Physically Inactive

BACKGROUND Physical activity ameliorates chronic stress. Latest research suggests a relation between resilience and physical fitness. Beneficial adaptations of the hypothalamic-pituitary-adrenal axis, the sympathetic nervous system, the endocannabinoid system, and the tryptophan pathway, induced by an active lifestyle, are considered to be resilience conducive. However, detailed knowledge on the molecular link between the effects of acute and chronic physical exercise and an improved resilience is missing. OBJECTIVE Therefore, we implement a human exercise intervention trial addressing the main hypotheses: (1) web-based exercise training improves aerobic capacity of physically inactive adults, which (2) is accompanied by improved resilience. In this setting, we will analyze the relation of resilience parameters with innate and acquired aerobic capacity as well as circulating signaling molecules. METHODS 70 healthy physically inactive (<150min/week physical activity) adults (18-45y) will be randomly assigned to an intervention or control group. Participants in the intervention group receive weekly training utilizing progressive endurance and interval running individually adapted to their training performance via web-based physician support. A standardized incremental treadmill exercise test is performed before and after the intervention period of eight weeks to determine innate and acquired aerobic capacity. Before and after the intervention psychological tests and questionnaires that characterize parameters implicated in resilience (including impulse control, working memory, stress coping, emotion regulation) will be applied. Blood, and saliva will be sampled for analysis of lactate, cortisol, endocannabinoids, catecholamines, kynurenic acid, cell-free DNA and further circulating signal transducers. Statistical analysis will provide comprehensive knowledge on the relation of aerobic capacity and resilience, and furthermore, the capacity of peripheral factors to mediate the promoting effects of exercise on resilience. RESULTS The study was registered in October 2019. Enrollment began in September 2019. Out of 161 subjects, who were initially screened via telefon survey, 43 fulfilled the inclusion criteria and were included. Among the 17 participants in the intervention group, and 14 participants in the control group, who completed the study (total 31), no serious adverse event has been reported. Four participants withdrew during the programm (individual reasons), and 8 participants have not yet completed or begun the program due to the Covid-19 pandemic. Enrollment and data analysis are ongoing, and results are expected to be submitted for publication in October 2021. CONCLUSIONS Our study aims to demonstrate that an increase in physical activity with a simultaneous improvement in aerobic capacity is associated with an increase in resilience. This study design allows to investigate the effect of an active lifestyle on circulating molecular marker levels and their relationship to resilience factors. This will offer novel approaches for the diagnosis of depression and the therapy by exercise prescription. CLINICALTRIAL DRKS00018078, registered October 02, 2019, German Clinical Trials Register. Retrospectively registered: First participant September 10, 2019.

scholarly journals Sauna Yoga Superiorly Improves Flexibility, Strength, and Balance: A Two-Armed Randomized Controlled Trial in Healthy Older Adults

2019 ◽  
Vol 16 (19) ◽  
pp. 3721 ◽  
Author(s):  
Bucht ◽  
Donath
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Minimization Method ◽  
Important Indicator ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Healthy Elderly

Besides strength and balance, flexibility is an important indicator of health-related physical fitness. Thus, the aim of this two-armed randomized controlled pilot trial was to investigate whether sauna yoga at a moderate temperature (50 °C) beneficially affects flexibility, strength, balance, and quality of life (QOL) in healthy elderly community dwellers. Participants were randomly assigned to an intervention group (INT, n = 11, age: 68.7 ± 5.9) or control group (CON, n = 12, age: 69.3 ± 4.9), using the minimization method. Age, physical activity, gender, and the primary outcome flexibility were used as strata for group allocation. Both groups completed similar exercises in the sauna over eight weeks. Only the INT group was exposed to moderate temperatures of 50 °C. Large and statistically significant improvement in favor of the sauna group (INT) was observed for the chair sit-and-reach test (INT: +83%, CON +3%, p = 0.028, nр² = 0.24). The shoulder and lateral spine flexibility were not relevantly affected. Strength in the lower extremities merely showed a tendency to significant changes (INT: 16%, CON: 3%, p = 0.061, nр² = 0.181). Additionally, balance abilities, with eyes closed, improved (INT: 187%, CON +58%, p = 0.056, nр² = 0.189) in favor of the INT group. QOL only improved in favor of the INT for environmental dimension (INT: +7%, CON: 0%, p = 0.034, nр² = 0.227). These first but preliminary findings indicate that sauna yoga may serve as a promising and feasible means to improve flexibility in elderly people. Strength and balance do not meaningfully benefit from a sauna environment, although strength improved to a slightly higher extent in the sauna group. Future large-scale research is needed to elucidate underlying mechanisms and corroborate these findings

scholarly journals Effectiveness of diabetes self-management education and support via a smartphone application in insulin-treated patients with type 2 diabetes: results of a randomized controlled trial (TRIGGER study)

2019 ◽  
Vol 7 (1) ◽  
pp. e000981 ◽  
Author(s):  
Anne Meike Boels ◽  
Rimke C Vos ◽  
Lioe-Ting Dijkhorst-Oei ◽  
Guy E H M Rutten
Keyword(s):  
Type 2 Diabetes ◽  
Dietary Habits ◽  
Management Education ◽  
Intervention Group ◽  
Self Management ◽  
Smartphone App ◽  
Control Group ◽  
Hypoglycemic Event ◽  
Randomized Controlled

ObjectiveTo investigate the effect of diabetes self-management education and support via a smartphone app in individuals with type 2 diabetes on insulin therapy.Research design and methodsOpen two-arm multicenter parallel randomized controlled superiority trial. The intervention group (n=115) received theory and evidence-based self-management education and support via a smartphone app (optionally two or six times per week, once daily at different times). The control group (n=115) received care as usual. Primary outcome: HbA1c at 6 months. Other outcomes included HbA1c ≤53 mmol/mol (≤7%) without any hypoglycemic event, body mass index, glycemic variability, dietary habits and quality of life. We performed multiple imputation and regression models adjusted for baseline value, age, sex, diabetes duration and insulin dose.ResultsSixty-six general practices and five hospital outpatient clinics recruited 230 participants. Baseline HbA1c was comparable between groups (8.1% and 8.3%, respectively). At 6 months, the HbA1c was 63.8 mmol/mol (8.0%) in the intervention vs 66.2 mmol/mol (8.2%) in the control group; adjusted difference −0.93 mmol/mol (−0.08%), 95% CI −4.02 to 2.17 mmol/mol (−0.37% to 0.20%), p=0.557. The odds for achieving an HbA1c level ≤7% without any hypoglycemic event was lower in the intervention group: OR 0.87, 95% CI 0.33 to 2.35. There was no effect on secondary outcomes. No adverse events were reported.ConclusionsThis smartphone app providing diabetes self-management education and support had small and clinically not relevant effects. Apps should be more personalized and target individuals who think the app will be useful for them.Trial registration numberNTR5515.

Pilot Trial of a Social Cognitive Theory-Based Physical Activity Intervention Delivered by Nonsupervised Technology in Persons With Multiple Sclerosis

2015 ◽  
Vol 12 (7) ◽  
pp. 924-930 ◽  
Author(s):  
Yoojin Suh ◽  
Robert W. Motl ◽  
Connor Olsen ◽  
Ina Joshi
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Social Cognitive Theory ◽  
Behavioral Intervention ◽  
Social Cognitive ◽  
Cognitive Theory ◽  
Pilot Trial ◽  
Intervention Group ◽  
Self Report ◽  
Phone Calls

Background:Physical inactivity is prevalent in people with multiple sclerosis (MS) and this highlights the importance of developing behavioral interventions for increasing physical activity (PA) in MS. This pilot trial examined the efficacy of a 6-week, behavioral intervention based on social cognitive theory (SCT) delivered by newsletters and phone calls for increasing PA in persons with MS who were physically inactive and had middle levels of self-efficacy.Methods:The sample included 68 persons with relapsing-remitting MS who were randomly assigned into intervention and control groups. The intervention group received SCT-based information by newsletters and phone calls, whereas the controls received information regarding topics such as stress management over 6 weeks. Participants completed self-report of PA and social cognitive variables.Results:The intervention group had a significant increase in self-reported PA (d = 0.56, P = .02) over the 6 weeks, but the controls had a nonsignificant change (d = –0.13, P = .45). Goal setting was changed in the intervention group (d = 0.68, P ≤ .01) and identified as a significant mediator of change in self-reported PA.Conclusions:This study provides initial evidence for the benefit of a theory-based behavioral intervention for increasing PA in MS.

Internet intervention for increasing physical activity in persons with multiple sclerosis

2010 ◽  
Vol 17 (1) ◽  
pp. 116-128 ◽  
Author(s):  
Robert W Motl ◽  
Deirdre Dlugonski ◽  
Thomas R Wójcicki ◽  
Edward McAuley ◽  
David C Mohr
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Goal Setting ◽  
Cognitive Theory ◽  
Intervention Group ◽  
Internet Intervention ◽  
The Internet ◽  
Control Group ◽  
Significant Change ◽  
Over Time

Background:Physical activity has been associated with improvements in walking mobility and quality of life in persons with multiple sclerosis (MS), and yet this population is largely sedentary and inactive compared with the general population. Objectives:We conducted a pilot, randomized controlled trial (RCT) for examining the effect of an Internet intervention based on social cognitive theory (SCT) for favorably increasing physical activity among persons with MS. We further examined variables from SCT as possible mediators of the Internet intervention. Methods:We randomly allocated 54 persons with MS into either an Internet intervention condition or a waitlist control condition. The participants completed measures of physical activity, self-efficacy, outcome expectations, functional limitations, and goal setting before and after the 12-week period. Results:The intervention group reported a statistically significant ( p = 0.01) and large increase in physical activity over time ( d = 0.72), whereas the control group had a small ( d = 0.04) and non-significant change in physical activity ( p = 0.71). The intervention group further reported a statistically significant ( p = 0.001) and large increase in goal setting over time ( d = 0.97), whereas the control group had a small ( d = −0.13) and non-significant change ( p = 0.17). The change in goal setting over time mediated the effect of the Internet intervention on physical activity behavior. Conclusions:This pilot study sets the stage for a subsequent RCT that includes a larger sample of persons with MS, longer intervention period along with a follow-up, objective measure of physical activity, and secondary outcomes of walking mobility and QOL.

scholarly journals Effectiveness of a Worksite Intervention for Male Construction Workers on Dietary and Physical Activity Behaviors, Body Mass Index, and Health Outcomes: Results of a Randomized Controlled Trial

2017 ◽  
Vol 32 (3) ◽  
pp. 795-805 ◽  
Author(s):  
Laura Viester ◽  
Evert A. L. M. Verhagen ◽  
Paulien M. Bongers ◽  
Allard J. van der Beek
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Construction Workers ◽  
Blue Collar ◽  
Control Group ◽  
Intervention Effect ◽  
Lifestyle Behavior ◽  
Randomized Controlled ◽  
Sweetened Beverages

Purpose: To evaluate the effectiveness of an individually tailored intervention for improvement in lifestyle behavior, health indicators, and prevention and reduction of overweight among construction workers. Design: Randomized controlled trial. Setting: Various blue-collar departments of a large construction company in the Netherlands. Participants: Blue-collar workers randomized to an intervention (n = 162) or a control group (n = 152). Intervention: The intervention group received individual coaching sessions, tailored information, and materials to improve lifestyle behavior during a 6-month period, and the control group received usual care. Measures: Body weight, body mass index (BMI), waist circumference, physical activity (PA) levels, dietary behavior, blood pressure, and blood cholesterol were assessed. Analysis: Effectiveness of the intervention on outcome measures at 6- and 12-month follow-up was assessed by using linear and logistic regression models adjusting for baseline levels. Results: After 6 months, a statistically significant intervention effect was found on body weight ( B = −1.06, P = .010), BMI ( B = −0.32, P = .010), and waist circumference ( B = −1.38, P = .032). At 6 months, the percentage of those meeting public health guidelines for PA increased significantly in the intervention group compared to the control group ( B = 2.06, P = .032), and for sugar-sweetened beverages, an intervention effect was found at 6 months as well ( B = −2.82, P = .003). At 12 months, for weight-related outcomes, these differences were slightly smaller and no longer statistically significant. The intervention was not effective on the total amount of moderate to vigorous PA and other dietary and health outcomes. Conclusion: Intervention participants showed positive changes in vigorous PA and intake of sugar-sweetened beverages compared to controls, as well as effects on weight-related outcomes at 6 months. Long-term effects were still promising but not statistically significant.

scholarly journals Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

2020 ◽  
Author(s):  
Yu Wang ◽  
Guang-Xia Shi ◽  
Zhong-Xue Tian ◽  
Jun-Hong Liu ◽  
You-Sheng Qi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Lifestyle Modification ◽  
Pilot Trial ◽  
Intervention Group ◽  
Normal Blood ◽  
Control Group ◽  
Normal Blood Pressure ◽  
Randomized Controlled ◽  
Acupoint Stimulation

Abstract Background:High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-pharmaceutical therapy option to control BP. This trial aims to determine the efficacy effectiveness and safety of TEAS combined with lifestyle modification for high-normal BP. Methods/design:This prospective, randomized and parallel clinical trial will be conducted in a community service center in China. Sixty participants with high-normal BP will be randomly allocated to receive TEAS plus lifestyle modification (intervention group) or lifestyle modification alone (control group) in a 1:1 ratio. In addition to lifestyle modification, the intervention group will receive TEAS at four acupoints for 30 minutes, 4 times weekly for 12 weeks for a total of 48 sessions at home. The control group will receive same lifestyle modification but no TEAS. The primary outcome will be the change in mean systolic blood pressure at 12-week from the baseline measurement. Secondary outcomes include the change of mean diastolic blood pressure, proportion of subjects with progression to hypertension, quality of life, physical activity, body mass index and waist circumference. Adverse events during the trial will be monitored.Discussion:This trial will explore the feasibility and provide potential evidence for the efficacy effectiveness and safety of TEAS plus lifestyle modification for high-normal BP. Furthermore, this pilot trial is being undertaken to determine the feasibility of a full scale definitive randomized controlled trial. The results of this study will be published in a peer-reviewed journal.Trial registration:Chinese Clinical Trial Registry, ChiCTR 1900024982. Registered on August 6, 2019.

scholarly journals Evaluation of FunFRIENDS program in prevention of anxiety in Brazilian children: a randomized controlled pilot trial

2020 ◽  
Vol 25 (11) ◽  
pp. 4497-4508
Author(s):  
Lina Maria Herrera Nunez Rivero ◽  
André Luiz Monezi Andrade ◽  
Larissa Zeggio Perez Figueredo ◽  
Bruno de Oliveira Pinheiro ◽  
Denise De Micheli
Keyword(s):  
Pilot Trial ◽  
Intervention Group ◽  
Anxiety Symptoms ◽  
Future Research ◽  
Control Group ◽  
Behavioral Profile ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Allocation Ratio ◽  
The City

Abstract This study aimed to evaluate the effects of the FunFRIENDS protocol on anxiety symptoms, internalizing problems and prosocial behavior in 4- to 5-year old children. Participated of this study 43 children with an allocation ratio of 1:1 between groups (Intervention Group [IG], N = 21; Control Group [CG], N = 22) from a public school in the city of Sao Paulo participated in the study. Behaviors were evaluated by using standardized questionnaires (PAS, CBCL, SDQ, SCBE) assessing the behavioral profile of the children at three different periods; baseline (T0), one month (T1) and three months (T2) after the intervention. It was observed a reduction in the intensity of anxiety symptoms in the IG after the intervention but with no significant effect. Overall, there were no significant differences between the IG and the CG in most behaviors on all periods evaluated. On both Intention-to-Treat analyses also it was not detected significant effects of the intervention. This is the first Brazilian study evaluating the effects of FunFRIENDS program and the implications of these findings are discussed and its significance for future research.

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