scholarly journals Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART) (Preprint)

2019 ◽  
Author(s):  
Bárbara De Barros Gonze ◽  
Ricardo Da Costa Padovani ◽  
Maria Do Socorro Simoes ◽  
Vinicius Lauria ◽  
Neli Leite Proença ◽  
...  

BACKGROUND The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. OBJECTIVE We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. METHODS We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (&lt;10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. RESULTS Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; <i>P</i>=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. CONCLUSIONS The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. CLINICALTRIAL Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

10.2196/14322 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e14322 ◽  
Author(s):  
Bárbara De Barros Gonze ◽  
Ricardo Da Costa Padovani ◽  
Maria Do Socorro Simoes ◽  
Vinicius Lauria ◽  
Neli Leite Proença ◽  
...  

Background The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. Objective We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. Methods We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. Results Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. Conclusions The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. Trial Registration Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Maria do Socorro Morais Pereira Simões ◽  
Bárbara de Barros Gonze ◽  
Neli Leite Proença ◽  
Vinicius Tonon Lauria ◽  
Vinícius Demarchi Silva Terra ◽  
...  

Abstract Background There is scientific evidence suggesting that app-based interventions targeted to increase the level of physical activity might be effective, although multicomponent interventions appear to be more effective than app-based interventions alone. Despite the motivating results, it remains unclear whether or not app-based interventions can increase the level of physical activity and cardiovascular health. Our study aims to investigate the effect of a smartphone app combined with gamification on the level of physical activity of adults and older adults. The specific aims are (1) to verify the effects of the intervention on cardiometabolic and cardiovascular health, lung function, and cardiorespiratory fitness; and (2) to verify the relationship between age group and the response rate. Methods/design We will conduct a sequential multiple assignment randomized trial (SMART). The adaptive intervention protocol will last 6 months. After baseline assessments, participants will be randomized into one of three groups (group 1: app + tailored messages; group 2: app + tailored messages + gamification I; control group: physical activity counseling). For 12 weeks, we will record the average number of steps per day of participants from groups 1 and 2. At 6 weeks from initiation of recording, participants will be classified into responders and non-responders according to their increase in the average number of daily steps; all those considered as non-responders will be re-randomized, with the chance to participate in a third group – group 3: app + tailored messages + gamification II. Finally, at 12 weeks, participants will continue using the app but will no longer receive direct intervention from investigators. All participants will be reassessed at 3 and 6 months from baseline. Our pilot SMART will require 42 participants (14 per arm). Following the SMART pilot, we will calculate the sample size for the trial based on the variation of the average number of steps/day, including an up to 40% loss to follow-up and a less optimistic nonresponse rate of 65%. Discussion To our knowledge, this will be the first trial with adaptive intervention to test the effectiveness of using a smartphone app to increase the level of physical activity of adults and older adults. Trial registration Brazilian Clinical Trials Registry: RBR-8xtc9c. Registered on 3 August 2018, http://www.ensaiosclinicos.gov.br; UTN number: U1111–1218-1092.


2021 ◽  
Vol 15 (7) ◽  
pp. 2343-2347
Author(s):  
YU. S. Ivanchuk ◽  
L.V. Tribuntсeva ◽  
A.V. Budnevsky ◽  
N.I. Ostroushko ◽  
YA. S. Shkatova ◽  
...  

Background. Physical activity is associated with better asthma control and life quality in asthma. Osteoarthritis is one of the less studied comorbidities in asthmatic patients. Methods. The study included 38 patients diagnosed with asthma, 65 patients with asthma and osteoarthritis, and 40 volunteers who did not suffer from asthma and osteoarthritis. During the study, 3 groups were formed: Group 1 consisted of patients with asthma; Group 2 included patients with both asthma and osteoarthritis, Control group consisted of volunteers. Spirometry, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (АСТ) were used in asthmatic patients. International Physical Activity Questionnaire (IPAQ) in its short from was filled by all the participants. Results. Both Group 1 and Group 2 did not engage in vigorous physical activity. Median of MET-min/week total (1825) was significantly less in Group 2 compared with Control and Group 1 (p=0.0000 and p=0.0169, respectively). MET-min/week total had positive correlations with ACT (r=0.50, p<0.05), AQLQ(S) total (r=0.58, p<0.05), AQLQ(S) activity domain (r=0.28, p<0.05), AQLQ(S) emotions domain (r=0.24, p<0.05), AQLQ (S) symptoms domain (r=0.34, p<0.05), FVC (r=0,28, p<0.05), FEV1 (r=0,37, p<0.05), Index Tiffno (r=0,18, p<0.05). Minutes/week sitting time had a negative correlation with ACT values (r=-0.33, p<0.05), AQLQ(S) total values (r=-0.39, p<0.05). Conclusion. Patients with asthma and osteoarthritis spend significantly less time on moderate activity, walking compared with asthmatics not suffering from osteoarthritis; they avoid vigorous activity. Higher physical activity is associated with better life quality, asthma control and lung function, thus paying attention to osteoarthritis in asthmatic patients is crucial. Key words: life quality, physical activity, asthma, osteoarthritis


2011 ◽  
Vol 8 (s2) ◽  
pp. S267-S274 ◽  
Author(s):  
Scott J. Strath ◽  
Ann M. Swartz ◽  
Sarah J. Parker ◽  
Nora E. Miller ◽  
Elizabeth K. Grimm ◽  
...  

Background:Increasing physical activity (PA) levels in older adults represents an important public health challenge. The purpose of this study was to evaluate the feasibility of combining individualized motivational messaging with pedometer walking step targets to increase PA in previously inactive and insufficiently active older adults.Methods:In this 12-week intervention study older adults were randomized to 1 of 4 study arms: Group 1—control; Group 2—pedometer 10,000 step goal; Group 3—pedometer step goal plus individualized motivational feedback; or Group 4—everything in Group 3 augmented with biweekly telephone feedback.Results:81 participants were randomized into the study, 61 participants completed the study with an average age of 63.8 ± 6.0 years. Group 1 did not differ in accumulated steps/day following the 12-week intervention compared with participants in Group 2. Participants in Groups 3 and 4 took on average 2159 (P < .001) and 2488 (P < .001) more steps/day, respectively, than those in Group 1 after the 12-week intervention.Conclusion:In this 12-week pilot randomized control trial, a pedometer feedback intervention partnered with individually matched motivational messaging was an effective intervention strategy to significantly increase PA behavior in previously inactive and insufficiently active older adults.


Author(s):  
Orlagh Farmer ◽  
Kevin Cahill ◽  
Wesley O’Brien

Girls are less active than boys throughout childhood and adolescence, with limited research focusing on female community sports-based programs. This study aims to assess the effectiveness of a multi-component, community sports-based intervention for increasing girl’s physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing, as relative to a second treatment group (the traditionally delivered national comparative program), and a third control group. One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban) were allocated to one of three conditions: (1) Intervention Group 1 (n = 43) received a novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention; (2) Intervention Group 2 (n = 44) used the traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention (group 1 or 2) conditions and were expected to carry out their usual LGF community sports activities. Primary outcome measurements (at both pre- and 10-week follow up) examining the effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support). Following a two (pre to post) by three (intervention group 1, intervention group 2, and control group 3) mixed-model ANOVA, it was highlighted that intervention group 1 significantly increased in PA (p = 0.003), FMS proficiency (p = 0.005) and several psychological correlates of PA (p ≤ 0.005). The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.


2021 ◽  
pp. 43-50
Author(s):  
N. V. Drohomyretska

Aim of the research. Study the peculiarities of chronic inflammatory processes of the internal genital organs in women against the background of varicose veins of the pelvis minor. Materials and methods. In the comparative aspect, the main points of the clinical characteristics of 30 women of the control and 120 patients of the main groups (with chronic inflammatory processes of the internal genital organs against the background of varicose veins of the pelvis, isolated chronic inflammatory processes of the internal genital organs) are represented in the work. Results. Performed researches have shown that the vast majority of women in the group 1 were engaged in manual labor, of which 32 were workers ((47,1±6,1) %), 13 – were housewives ((19,1±4,8) %). The proportion of unemployed among patients of the group 2 was 1.2-fold higher than of the group 1, prolonged static load in a standing or sitting position was observed in 38 ((55,9±6,0) %) and in 7 ((10,5±3,7) %) cases, respectively; excessive physical activity, especially related to the lifting of loads – in 12 (23,1±4,6) %) and in 6 (11,05±4,4) %) cases, respectively; and this definitely made the negative impact on the venous hemodynamics. Statistical calculations showed that the risk of VPM (varicosity of pelvis minor) in female workers was significantly higher compared to the control group (OR 3,56; 95 % CI 1,29-9,80; p=0,02) and group 2 (OR 2,67; 95 % CI 1,21-5,86; p=0,02). Analysis of the peculiarities of genital function has shown that the early sexual activity (up to 18 years) was started by 19 ((27,9±5,4) %) women of the group 1, by 22 women ((42,3±6,9) %) – of the group 2, that was 1,8-fold more than in patients of the control group (7; (23,3±4,7) %). The women of the group 1 were found to have a significantly higher risk of sexual dysfunction compared to the group 2: dyspareunia (OR 2,39; 95 % CI 1,14-5,04; p=0,03) and anorgasmia (OR 2,60; 95 % CI 1,12-6,06; p=0,04). Regarding the use of contraceptives, it was found that almost half of the patients of the first group resorted to interrupted sexual intercourse, which adversely affects the venous hemodynamics of the pelvis and significantly increases the risk of VPM against the background of CIPIGO (chronic inflammatory processes of the internal genital organs) (OR 2,41; 95 % CI 1,11-5,24; p=0,04). Studying the reproductive history of patients, it was determined that women in the group 1 have had 3,4-fold higher birth parity compared to the group 2 (p<0,05), which can also be considered a leading risk factor for VPM. In addition, in the research groups there was a significant proportion of miscarriages (4,7-fold more in the group 1; p<0,05) and stillbirths, which may be a consequence of the past acute inflammatory diseases of specific etiology. Conclusions. Anamnestic data (static lifestyle and physical activity, miscarriages, high parity of childbirth), as well as peculiarities of the clinical course of chronic inflammatory processes of the internal genital organs in women against the background of varicose veins of the pelvis minor (severe chronic pelvic pain, swelling and aching fornices, dyspareunia, sexual dysfunction) should be the leading factors in the selection of patients for the use of an advanced diagnostic algorithm (ultrasound examination of the lesser pelvic veins in combination with color Doppler examination).


2019 ◽  
Vol 51 (Supplement) ◽  
pp. 438
Author(s):  
Victor Z. Dourado ◽  
Bárbara Gonze ◽  
Maria do Socorro Simões ◽  
Neli Proença ◽  
Evandro Sperandio ◽  
...  

2019 ◽  
Vol 20 (1) ◽  
pp. 12-18
Author(s):  
Sameh El-Nabtity

The present study aimed to investigate the prophylactic effect of Cymbopogon proximus and Alhagi maurorum on Sulfadimidine induced urolithiasis in rabbits . Thirty New Zealand male rabbits were allocated into six equal groups (each of five): Group (1) was used as a negative control. Group(2) were administered sulfadimidine (200mg/kg) by intramuscular injection.Groups(3) and (4) were administered sulfadimidine(200mg/kg) by intramuscular injection and 330mg/kg of Cymbopogon proximus alcoholic and aqueous extracts respectively orally.Groups(5) and (6) were administered sulfadimidine(200mg/kg) by intramuscular injection and 400mg/kg of Alhagi maurorum alcoholic and aqueous extracts respectively orally. The period of experiment was 10 days. Blood and urine samples were collected from rabbits on the 10th day. The results recorded a significant decrease in serum creatinine, urea, uric acid and crystalluria in Cymbopogon proximus and Alhagi maurorum groups compared to sulfadimidine treated group.We conclude that Cymbopogon proximus and Alhagi maurorum have a nephroprotective and antiurolithiatic effects against sulfadimidine induced crystalluria.


2021 ◽  
Vol 14 (1) ◽  
pp. 656-664
Author(s):  
I.R. Volchkova ◽  
A.V. Yumashev ◽  
V.V. Borisov ◽  
V.I. Doroshina ◽  
E.A. Kristal ◽  
...  

Introduction: Removable dentures are used by 20% of the population. These may be accompanied by denture stomatitis in 15-70% of patients. The choice of the optimal cleansing agent for removable dental prostheses is of high significance. Aim: The aim of our research was to study the influence of removable denture cleansing products on the adhesion of microorganisms and yeast. Materials and Methods: We manufactured 144 specimens of standardized round shape with a diameter of 10 mm from 4 types of modern polymeric materials used by prosthetic dentistry to produce removable dentures, 12 specimens of each material were placed into suspensions of bacterial cultures of Staphylococcus aureus, Escherichia coli, Candida albicans, then into “ClearaSept” (Test group 1), “Рrotefix active cleanser” (Test group 2), saline solution (Control group), followed by nutrient media. The adhesion index was calculated and analyzed. Results: There was no reliable lowering of adhesion index of Staphylococcus Aureus to all materials detected in Test group 1 (U=6, p>0.05 for Bio XS; U=8, p>0.05 for Dental D, Denotokeep Peek, Vertex Rapid Simplified). In Test group 2, the adhesion index of Staphylococcus Aureus reliably decreased to all materials compared to the Control group (U=0, p≤0.01). The adhesion index of Candida albicans and Escherichia coli to all materials in Test group 1 had a minor to moderate reliable reduction compared to the Control group (U=0, p≤0.01). Test group 2 showed a significant reliable decrease in Candida albicans and Escherichia coli adhesion index to all materials in comparison with the Control group (U=0, p≤0.01). Conclusion: The research showed an unreliable or minor and moderate reliable decrease in microorganisms adhesion index depending on the microorganism species after treatment of denture material specimens by antibacterial soap “ClearaSept” and a reliable significant decrease in microbial and yeast adhesion after application of Protefix active cleaner solution, which demonstrates a more significant antimicrobial effect in comparison to “ClearaSept” against Staphylococcus aureus, Escherichia coli, and Candida albicans.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Demenko ◽  
G.A Chumakova

Abstract Background Mental disorders in patients with cardiovascular disease have a significant impact on the course, the prognosis of the underlying disease and quality of life (QOL). Objective We aimed to examine the prevalence of anxiety and depressive disorders and their impact on the quality of life in patients with atrial fibrillation (AF). Materials and methods In 52 with permanent AF and 50 with paroxysmal AF patients, we administered the depression scale Tsung, the scale of situational anxiety (SA) and personal anxiety (PA) Spielberger-Hanin; QOL was assessed the SF-36 quality of life assessment scale. Correlation analysis using Spearman's rank correlation coefficient. Results The prevalence symptoms mild depression situational or neurotic genesis was 21.1% (12 patients) in Group 1 and 12.0% (6 patients) in Group 2 (p&gt;0.05). Subdepressive state was two percents of patients in Group 1 and Group 2. The incidence SA was 59.6% (31 patients) in Group 1 and 52.0% (26 patients) in Group 2. The incidence PA was 74.0% (37 patients) in Group 2 and 67.3% (35 patients) in Group 1. The average score the physical component of health (PCH) was 29,8±4,3 in Group 1, the mental component of health (MCH) – 49.5±7.4 points; p&lt;0.05. In Group 2: PCH – 44.8±6.6 points, MCH – 26.6±7.5 points; p&lt;0.05. Correlation analysis showed negative strong correlations between SA and MCH (r=−0.64, p=0.0005) and between PA and MCH (r=−0.69, p&lt;0.0001), between SA and PCH (r=−0.71, p=0.0001), between depression and PCH (r=−0.69, p=0.023). Negative statistically significant correlation between depression and MCH (r=−0.69, p=0.54) and negative medium correlation between depression and PCH (r=−0.64, p=0.23). Conclusion These findings suggest that we did not identify patients with symptoms of a true depressive (that can cause pseudodementia and influenced to complete tests). 16.5% patients with AF had mild depression of situational or neurotic genesis. Depression may be a pathogenetic factor of AF or develop because of paroxysms AF – psychological stress. More than 50% patients in Group 1 and Group 2 had an increased anxiety score. SA is more common in patients with permanent AF, probably because older people difficult to adapt to a new situation. PA is more common in patient with paroxysmal AF, probably because disease is sudden and causes anxiety. The PCH of QOL is more impairment in patients with permanent AF, because complications (for example heart failure) impairment physical activity. However, PCH also reduced in patient with paroxysmal AF, because disease is sudden may occur during physical activity. The MCH of QOL is more impairment in patients with paroxysmal AF, because waiting attack effect on mental health and social functioning. An increased level of anxiety and depression negatively affected the mental and physical health of patients with AF. Funding Acknowledgement Type of funding source: None


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