Dataset Information

Effectiveness of Distance Technology in Promoting Physical Activity in Cardiovascular Disease Rehabilitation: Cluster Randomized Controlled Trial, A Pilot Study.

ABSTRACT:

Background

Physical activity is beneficial for cardiovascular rehabilitation. Digitalization suggests using technology in the promotion of physical activity and lifestyle changes. The effectiveness of distance technology interventions has previously been found to be similar to that of conventional treatment, but the added value of the technology has not been frequently studied.

Objective

The aim of this pilot study was to investigate whether additional distance technology intervention is more effective in promoting physical activity than non-technology-based treatment in 12 months of cardiac rehabilitation.

Methods

The cardiovascular disease rehabilitation intervention consisted of three 5-day inpatient periods in a rehabilitation center and two 6-month self-exercise periods at home in between. Participants were recruited from among cardiac patients who attended the rehabilitation program and were cluster-randomized into unblinded groups: conventional rehabilitation control clusters (n=3) and similar rehabilitation with additional distance technology experimental group clusters (n=3). Experimental groups used Fitbit Charge HR for self-monitoring, and they set goals and reported their activity using Movendos mCoach, through which they received monthly automated and in-person feedback. Physical activity outcomes for all participants were measured using the Fitbit Zip accelerometer and the International Physical Activity Questionnaire.

Results

During the first 6 months, the experimental group (n=29) engaged in light physical activity more often than the control group (n=30; mean difference [MD] 324.2 minutes per week, 95% CI 77.4 to 571.0; P=.01). There were no group differences in the duration of moderate to vigorous physical activity (MD 12.6 minutes per week, 95% CI -90.5 to 115.7; P=.82) or steps per day (MD 1084.0, 95% CI -585.0 to 2752.9; P=.20). During the following 6 months, no differences between the groups were observed in light physical activity (MD -87.9 minutes per week, 95% CI -379.2 to 203.3; P=.54), moderate to vigorous physical activity (MD 70.9 minutes per week, 95% CI -75.7 to 217.6; P=.33), or steps per day (MD 867.1, 95% CI -2099.6 to 3833.9; P=.55).

Conclusions

The use of additional distance technology increased the duration of light physical activity at the beginning of cardiac rehabilitation (for the first 6 months), but statistically significant differences were not observed between the two groups for moderate or vigorous physical activity or steps per day for both 6-month self-exercise periods.

Trial registration

ISRCTN Registry ISRCTN61225589; https://doi.org/10.1186/ISRCTN61225589.

SUBMITTER: Hakala S

PROVIDER: S-EPMC8277324 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCardiac rehabilitation (CR) is an exercise-based program prescribed after cardiac events associated with improved physical, mental, and social functioning; however, many patients return to a sedentary lifestyle leading to deteriorating functional capacity after discharge from CR. Physical activity (PA) is critical to avoid recurrence of cardiac events and mortality and maintain functional capacity. Leveraging mobile health (mHealth) strategies to increase adherence to PA is a promising approach. Based on the social cognitive theory, we sought to determine whether mHealth strategies (Movn mobile app for self-monitoring, supportive push-through messages, and wearable activity tracker) would improve PA and functional capacity over 2 months.ObjectiveThe objectives of this pilot randomized controlled trial were to examine preliminary effects of an mHealth intervention on group differences in PA and functional capacity and group differences in depression and self-efficacy to maintain exercise after CR.MethodsDuring the final week of outpatient CR, patients were randomized 1:1 to the intervention group or usual care. The intervention group downloaded the Movn mobile app, received supportive push-through messages on motivation and educational messages related to cardiovascular disease (CVD) management 3 times per week, and wore a Charge 2 (Fitbit Inc) activity tracker to track step counts. Participants in the usual care group wore a pedometer and recorded their daily steps in a diary. Data from the 6-minute walk test (6MWT) and self-reported questionnaires were collected at baseline and 2 months.ResultsWe recruited 60 patients from 2 CR sites at a community hospital in Northern California. The mean age was 68.0 (SD 9.3) years, and 23% (14/60) were female; retention rate was 85% (51/60). Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02). There was no difference between groups for the 6MWT, depression, or self-efficacy to maintain exercise.ConclusionsThis intervention addresses a major public health initiative to examine the potential for mobile health strategies to promote PA in patients with CVD. Our technology-based pilot mHealth intervention provides promising results on a pragmatic and contemporary approach to promote PA by increasing daily step counts after completing CR.Trial registrationClinicalTrials.gov NCT03446313; https://clinicaltrials.gov/ct2/show/NCT03446313.

Project description:BACKGROUND:Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE:The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS:Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS:A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; Pinteraction=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; Pinteraction=.004; effect size of -0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; Pinteraction=.004; effect size of -0.36) remained constant, but deteriorated in UC. CONCLUSIONS:This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION:ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1136/bmjopen-2017-016781.

Project description:BackgroundThe use of health technologies and gamification to promote physical activity has increasingly been examined, representing an opportunistic method for harnessing social support inherent within existing social ties. However, these prior studies have yielded mixed findings and lacked long-term follow-up periods. Thus, a pilot cluster randomized controlled trial was conducted to gauge the feasibility and preliminary efficacy of a digital gamification-based physical activity promotion approach among teams of insufficiently active adults with existing social ties.MethodsTeams (N = 24; 116 total participants) were randomized to either a 12-week intervention (Fitbit, step goals, app, feedback; TECH) or the same program plus gamification (TECH + Gamification). Mixed effects models were used to compare group differences in treatment adherence, and changes in social support, steps, and moderate-to-vigorous physical activity at 12 weeks and 52 weeks from baseline, adjusted for sociodemographic characteristics and team size.ResultsTECH had a lower mean number of days of Fitbit self-monitoring versus TECH + Gamification during the intervention (adjusted difference: -.30; 95% CI, -.54 to -.07; P = .01). Post-intervention, TECH had 47% lower odds of self-monitoring 7 days per week versus TECH + Gamification (.53; 95% CI, .31 to .89; P = .02). No differences were observed between TECH + Gamification and TECH in increases in social support (0.04; 95% CI, -.21 to .29; P = .76), ActiGraph-measured daily steps (-425; 95% CI, -1065 to 215; P = .19), or moderate-to-vigorous physical activity minutes (-3.36; 95% CI, -8.62 to 1.91; P = .21) from baseline to 12 weeks or in the regression of these improvements by 1 year (Ps > .05). Although not significant in the adjusted models (Ps > .05), clinically meaningful differences in Fitbit-measured daily steps (TECH, 7041 ± 2520; TECH + Gamification, 7988 ± 2707) and active minutes (TECH, 29.90 ± 29.76; TECH + Gamification, 36.38 ± 29.83) were found during the intervention.ConclusionsA gamified physical activity intervention targeting teams of adults with existing social ties was feasible and facilitated favorable, clinically meaningful additive physical activity effects while in place but did not drive enhanced, long-term physical activity participation. Future investigations should explore optimal team dynamics and more direct ways of leveraging social support (training teams; gamifying social support).Trial registrationClinicaltrials.gov ( NCT03509129 , April 26, 2018).

Project description:BackgroundOverweight and obesity are major problems worldwide, and they lead to an increased risk for several diseases. The use of technology in the treatment of obesity is promising, but in the existing literature, there is considerable uncertainty regarding its efficacy. In this review, we included web- and mobile-based weight loss interventions that were implemented remotely in rehabilitation settings.ObjectiveThe aim of this systematic review is to study the effectiveness of physical activity-promoting web- and mobile-based distance weight loss interventions in rehabilitation settings on body composition in comparison with control groups that did not use technology.MethodsStudies were searched from 9 databases. The inclusion criteria were as follows: population: age 18-65 years; intervention: physical activity-promoting web- and mobile-based distance weight loss interventions; comparison: control groups without the use of technology; outcome: changes in BMI, waist circumference, or body fat percentage; study design: randomized controlled trial. The quality of the studies was assessed by 2 researchers. Meta-analysis was performed, and we also conducted a meta-regression analysis to evaluate the factors associated with the changes in body composition outcomes if statistical heterogeneity was observed.ResultsThe meta-analysis included 30 studies. The mean quality of the studies was 7 of 13 (SD 1.9; range 3-10). A statistically significant difference was observed in BMI (mean difference [MD] 0.83, 95% CI 0.51-1.15 kg/m2; P<.001), waist circumference (MD 2.45, 95% CI 1.83-3.07 cm; P<.001), and body fat percentage (MD 1.07%, 95% CI 0.74%-1.41%; P<.001) in favor of the weight loss groups using web- or mobile-based interventions. Meta-regression analyses found an association between personal feedback and BMI (P=.04), but other factors did not play a role in explaining statistical heterogeneity.ConclusionsWeb- and mobile-based distance weight loss interventions significantly reduced BMI, waist circumference, and body fat percentage. Future studies should focus on the comparability of the intervention content. Future studies are needed to better understand weight loss and identify which components are essential in achieving it.Trial registrationPROSPERO CRD42016035831; https://tinyurl.com/7c93tvd4.

Project description:Although physical activity can help mitigate or prevent multiple chronic diseases, most people in the U.S., especially high-poverty minority groups, engage in insufficient levels of physical activity. To test ways to promote more physical activity in high-poverty area public parks we conducted a randomized controlled intervention trial. After completing baseline measures of park-based physical activity using systematic direct observation three times/day each month for six months and assessing preferences for park programming among 1445 residents living within 1 mile of study parks, we randomized 48 parks in high poverty neighborhoods in the City of Los Angeles, California during 2013-2014 to four study arms: 1) free physical activity classes over a 6-month period, 2) a frequent user program where participants could win prizes based upon the number of visits they made to the park, 3) both the programs, and 4) neither one (control condition). We re-measured park use in 2014-2015 using the same methods during the six months the intervention programs were in operation. A total of 2047 free park classes were offered attracting 16,718 participants. The frequent user programs enrolled 1452 individuals and prizes were awarded to 830. Residents in the two study arms with free classes were more likely to report being aware of and participating in park-based physical activity programs; however, overall observed park-based physical activity increased similarly across all study arms. The process evaluation uncovered several barriers to program implementation, including inconsistent scheduling of classes, partly due to safety concerns among instructors. Multiple social factors interfere with leisure time physical activity among low-income populations, suggesting modest interventions may be insufficient to overcome these issues. Although new park programs can attract users, new programs alone may be insufficient to increase overall park use in low-income neighborhoods at times when the programs are not taking place.

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Project description:BACKGROUND:Unhealthy dietary behaviour-high intake of fat, sugar, and salt, and low intake of fruits and vegetables-is a major risk factor for chronic diseases. There is a lack of evidence-based interventions to promote healthy dietary intake among Indian populations. Therefore, we tested the effectiveness of an information technology-enabled 'SMART Eating' intervention to reduce the intake of fat, sugar and salt, and to increase the intake of fruits and vegetables. METHODS:In Chandigarh, a North Indian city, a cluster randomized controlled trial was implemented in twelve geographical clusters, based on the type of housing (i.e., LIG: Low-income group; MIG; Middle-income group, and HIG: High-income group-a proxy for socio-economic status). Computer-generated randomization was used to allocate clusters to intervention and comparison arms after pairing on the basis of socioeconomic status and geographical distance between clusters. The sample size was 366 families per arm (N = 732). One adult per family was randomly selected as an index case to measure the change in the outcomes. For behaviour change, a multi-channel communication approach was used, which included information technology-short message service (SMS), email, social networking app and 'SMART Eating' website, and interpersonal communication along with distribution of a 'SMART Eating' kit-kitchen calendar, dining table mat, and measuring spoons. The intervention was implemented at the family level over a period of six months. The comparison group received pamphlets on nutrition education. Outcome measurements were made at 0 and 6 months post-intervention at the individual level. Primary outcomes were changes in mean dietary intakes of fat, sugar, salt, and fruit and vegetables. Secondary outcomes included changes in body mass index (BMI), blood pressure, haemoglobin, fasting plasma glucose (FPG), and serum lipids. Mixed-effects linear regression models were used to determine the net change in the outcomes in the intervention group relative to the comparison group. RESULTS:Participants' mean age was 53 years, a majority were women (76%), most were married (90%) and 51% had completed a college degree. All families had mobile phones, and more than 90% of these families had access to Internet through mobile phones. The intervention group had significant net mean changes of -12.5 g/day (p<0.001), -11.4 g/day (p<0.001), -0.5 g/day (p<0.001), and +71.6 g/day (p<0.001) in the intake of fat, sugar, salt, and fruit and vegetables, respectively. Similarly, significant net changes occurred for secondary outcomes: BMI -0.25 kg/m2, diastolic blood pressure -2.77 mm Hg, FPG -5.7 mg/dl, and triglycerides -24.2mg/dl. The intervention had no effect on haemoglobin, systolic blood pressure, low-density lipoprotein cholesterol, or high-density lipoprotein cholesterol. CONCLUSION:The IT-enabled 'SMART Eating' intervention was found to be effective in reducing fat, sugar, and salt intake, and increasing fruit and vegetable consumption among urban adults from diverse socio-economic backgrounds. TRIAL REGISTRATION:Clinical Trial Registry of India CTRI/2016/11/007457.

Project description:BACKGROUND:Physical activity (PA) has demonstrated a decreased risk in various cancers and other chronic diseases; however, rural residents are less likely to attain recommended levels of PA compared to urban and suburban counterparts. Given rural residents make up 15% of the United States population, there is a need for novel approaches to increase PA among this population. The goal of the present study is to investigate the effectiveness of a multilevel intervention to increase PA rates among rural residents. METHODS/DESIGN:Guided by an ecological framework, a group-randomized design will be used to evaluate the effects of a three-level intervention for increasing PA among adult residents residing in 6 rural communities (n = 600) along with 6 control communities (n = 600). The intervention includes components at the individual (short message service [SMS] text messages), interpersonal (social support in walking groups), and community levels (events at existing trails). Innovative methods to encourage participation will be employed as well as a focus on life priorities (family, recreation, hobbies) other than health. Aim 1 includes a literature review and key informant interviews to determine the local contexts for intervention adaptation. Aim 2 will employ a set of interventions at the individual, interpersonal, and community-levels to evaluate their impact on moderate-to-vigorous PA as measured by self-reported (telephone survey) and objectively assessed (accelerometry) measures. These data are supplemented by location based on Global Positioning System and community audits, which provide information on recreational amenities, programs/policies, and street segments. DISCUSSION:This study is among the first of its kind to test a multilevel intervention in a rural setting, address life priorities that compliment health outcomes, and examine moderation between behavioral interventions and the natural environments where people are physically active. Our results will influence the field by enhancing the ability to scale-up innovative, PA interventions with the potential to reach high-risk, rural populations. TRIAL REGISTRATION:Clinical Trials NCT03683173 , September 25, 2018.