Dataset Information

The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial.

ABSTRACT:

Rationale & objective

People with end-stage kidney disease (ESKD) have very low physical activity, and the degree of inactivity is strongly associated with morbidity and mortality. We assessed the feasibility and effectiveness of a 12-week intervention coupling a wearable activity tracker (FitBit) and structured feedback coaching versus wearable activity tracker alone on changes in physical activity in hemodialysis patients.

Study design

Randomized controlled trial.

Setting & participants

55 participants with ESKD receiving hemodialysis who were able to walk with or without assistive devices recruited from a single academic hemodialysis unit between January 2019 and April 2020.

Interventions

All participants wore a Fitbit Charge 2 tracker for a minimum of 12 weeks. Participants were randomly assigned 1:1 to a wearable activity tracker plus a structured feedback intervention versus the wearable activity tracker alone. The structured feedback group was counseled weekly on steps achieved after randomization.

Outcome

The outcome was step count, and the main parameter of interest was the absolute change in daily step count, averaged per week, from baseline to completion of 12 weeks intervention. In the intention-to-treat analysis, mixed-effect linear regression analysis was used to evaluate change in daily step count from baseline to 12-weeks in both arms.

Results

Out of 55 participants, 46 participants completed the 12-week intervention (23 per arm). The mean age was 62 (± 14 SD) years; 44% were Black, and 36% were Hispanic. At baseline, step count (structured feedback intervention: 3,704 [1,594] vs wearable activity tracker alone: 3,808 [1,890]) and other participant characteristics were balanced between the arms. We observed a larger change in daily step count in the structured feedback arm at 12 weeks relative to use of the wearable activity tracker alone arm (Δ 920 [±580 SD] versus Δ 281 [±186 SD] steps; between-group difference Δ 639 [±538 SD] steps; P<0.05).

Limitations

Single-center study and small sample size.

Conclusion

This pilot randomized controlled trial demonstrated that structured feedback coupled with a wearable activity tracker led to a greater daily step count that was sustained over 12 weeks relative to a wearable activity tracker alone. Future studies are required to determine longer-term sustainability of the intervention and potential health benefits in hemodialysis patients.

Funding

Grants from industry (Satellite Healthcare) and government (National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK).

Trial registration

Registered at ClinicalTrials.gov with study number NCT05241171.

SUBMITTER: Malhotra R

PROVIDER: S-EPMC10962931 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial.

Malhotra Rakesh R Rahimi Sina S Agarwal Ushma U Katz Ronit R Kumar Ujjala U Garimella Pranav S PS Gupta Vineet V Chopra Tushar T Kotanko Peter P Ikizler T Alp TA Larsen Britta B Cadmus-Bertram Lisa L Ix Joachim H JH

American journal of kidney diseases : the official journal of the National Kidney Foundation 20230217 1

<h4>Rationale & objective</h4>People with end-stage kidney disease (ESKD) have very low physical activity, and the degree of inactivity is strongly associated with morbidity and mortality. We assessed the feasibility and effectiveness of a 12-week intervention coupling a wearable activity tracker (FitBit) and structured feedback coaching versus wearable activity tracker alone on changes in physical activity in hemodialysis patients.<h4>Study design</h4>Randomized controlled trial.<h4>Setting & p ...[more]

PMID: 36801430

Similar Datasets

Project description:BackgroundLittle is known of the effect of wearable devices on metabolic impairments in clinical settings. We hypothesized that a wearable device that can monitor and provide feedback on physical activity may help resolve metabolic syndrome.ObjectiveThis study aimed to examine the objective effects of the use of these devices on metabolic syndrome resolution.MethodsPatients diagnosed with metabolic syndrome were recruited. Participants were prescribed regular walking using a wearable device (Coffee WALKIE +Dv.3, GC Healthcare CI, Korea) on their wrist for 12 weeks. Participants received self-feedback on the amount of their exercise through an app on their mobile phone. The information on physical activities of the participants was uploaded automatically to a website. Thus, a trained nurse could provide individuals with feedback regarding the physical activity via telephone consultation on alternate weeks. Blood pressure (BP), body composition, fasting plasma glucose, and lipid profiles were recorded. The primary outcome was metabolic syndrome resolution. The secondary outcome was an improvement in the components of metabolic impairment.ResultsOf the 53 participants recruited, 20 participants with a median age of 46 (range 36-50) years completed the trial. There was no significant difference in the amount of calorie expenditure at weeks 4, 8, and 12. After 12 weeks, metabolic syndrome was resolved in 9 of 20 participants (45%), and the mean number of metabolic impairment components per person decreased from 3.4 to 2.9. Particularly, the mean systolic and diastolic BP decreased from mean 136.6 (SD 18.5) mm Hg to mean 127.4 (SD 19.5) mm Hg and from mean 84.0 (SD 8.1) mm Hg to mean 77.4 (SD 14.4) mm Hg (both P=.02), respectively.ConclusionsThis study found that a 12-week intervention via feedback, based on a wearable physical activity monitor, helped metabolic syndrome patients to be more engaged in regular walking and it improved impaired metabolic components, especially in BP. However, some practical challenges regarding patients' adherence and sustained engagement were observed.

Project description:BackgroundCommercially acquired wearable activity trackers such as the Fitbit provide objective, accurate measurements of physically active time and step counts, but it is unclear whether these measurements are more clinically meaningful than self-reported physical activity.ObjectiveThe aim of this study was to compare self-reported physical activity to Fitbit-measured step counts and then determine which is a stronger predictor of BMI by using data collected over the same period reflecting comparable physical activities.MethodsWe performed a cross-sectional analysis of data collected by the Health eHeart Study, a large mobile health study of cardiovascular health and disease. Adults who linked commercially acquired Fitbits used in free-living conditions with the Health eHeart Study and completed an International Physical Activity Questionnaire (IPAQ) between 2013 and 2019 were enrolled (N=1498). Fitbit step counts were used to quantify time by activity intensity in a manner comparable to the IPAQ classifications of total active time and time spent being sedentary, walking, or doing moderate activities or vigorous activities. Fitbit steps per day were computed as a measure of the overall activity for exploratory comparisons with IPAQ-measured overall activity (metabolic equivalent of task [MET]-h/wk). Measurements of physical activity were directly compared by Spearman rank correlation. Strengths of associations with BMI for Fitbit versus IPAQ measurements were compared using multivariable robust regression in the subset of participants with BMI and covariates measured.ResultsCorrelations between synchronous paired measurements from Fitbits and the IPAQ ranged in strength from weak to moderate (0.09-0.48). In the subset with BMI and covariates measured (n=586), Fitbit-derived predictors were generally stronger predictors of BMI than self-reported predictors. For example, an additional hour of Fitbit-measured vigorous activity per week was associated with nearly a full point reduction in BMI (-0.84 kg/m2, 95% CI -1.35 to -0.32) in adjusted analyses, whereas the association between self-reported vigorous activity measured by IPAQ and BMI was substantially smaller in magnitude (-0.17 kg/m2, 95% CI -0.34 to -0.00; P<.001 versus Fitbit) and was dominated by the Fitbit-derived predictor when compared head-to-head in a single adjusted multivariable model. Similar patterns of associations with BMI, with Fitbit dominating self-report, were seen for moderate activity and total active time and in comparisons between overall Fitbit steps per day and IPAQ MET-h/wk on standardized scales.ConclusionsFitbit-measured physical activity was more strongly associated with BMI than self-reported physical activity, particularly for moderate activity, vigorous activity, and summary measures of total activity. Consumer-marketed wearable activity trackers such as the Fitbit may be useful for measuring health-relevant physical activity in clinical practice and research.

Project description:BackgroundPhysical activity (PA) plays a fundamental role in combating the current obesity epidemic; however, most women who are overweight or obese are generally physically inactive. Wearable activity tracker interventions can help increase the PA levels in this population. Supplementing such interventions with behavioral support emails may further improve their effectiveness, but this remains to be confirmed.ObjectiveThis study aims to determine if adding behavioral support emails to a wearable activity tracker intervention can further increase PA levels among women who are overweight or obese in comparison to a wearable activity tracker-only intervention and a control condition.MethodsWomen with a BMI ≥25 kg/m2 who were not meeting the Canadian PA guidelines for aerobic and strength training were randomized into 1 of 3 groups. Group 1 received 6 weekly behavioral support emails, a wearable activity tracker, and a copy of the Canadian PA guidelines. Group 2 received a wearable activity tracker and a copy of the Canadian PA guidelines, and group 3 (control condition) received a copy of the Canadian PA guidelines. Self-reported data for walking and moderate to vigorous intensity PA were collected preintervention (week 0; prerandomization), postintervention (7 weeks postrandomization), and at follow-up (21 weeks postrandomization) and analyzed as metabolic equivalent of task minutes per week. In addition, potential mechanisms of behavior change (ie, basic psychological needs satisfaction and motivational regulations) were assessed for within- and between-group differences at all 3 time points. Data were analyzed using nonparametric statistical tests.ResultsA total of 49 women were recruited; data from 47 women (mean age 37.57 years, SD 11.78 years; mean BMI 31.69 kg/m2, SD 5.97 kg/m2) were available for analysis. Group 1 reported a significant increase in walking from preintervention to postintervention (χ22=7.5; P=.02) but not in moderate to vigorous intensity PA (P=.24). Group 1 also reported significant increases in perceptions of competence from preintervention to follow-up (χ22=7.6; P=.02) and relatedness from preintervention to follow-up (χ22=8.7; P=.005). Increases in perceived autonomy were observed for group 2 (χ22=7.0) and group 3 (χ22=10.6). There were no significant changes in the motivational regulations within the groups. The difference between the groups was not significant for any outcome variable.ConclusionsThe results suggest that adding behavioral support emails to a wearable activity tracker intervention may help to increase time spent walking and perceptions of competence and relatedness for PA among women who are overweight or obese.Trial registrationClinicalTrials.gov NCT03601663; http://clinicaltrials.gov/ct2/show/NCT03601663.

Project description:BackgroundPhysical activity has emerged as a modifiable behavioral factor to improve cognitive function. However, research on adherence to remote monitoring of physical activity in older adults is limited.ObjectiveThis study aimed to assess adherence to remote monitoring of physical activity in older adults within a pilot cohort from objective user data, providing insights for the scalability of such monitoring approaches in larger, more comprehensive future studies.MethodsThis study included 22 participants from the Boston University Alzheimer's Disease Research Center Clinical Core. These participants opted into wearing the Verisense watch as part of their everyday routine during 14-day intervals every 3 months. Eighteen continuous physical activity measures were assessed. Adherence was quantified daily and cumulatively across the follow-up period. The coefficient of variation was used as a key metric to assess data consistency across participants over multiple days. Day-to-day variability was estimated by calculating intraclass correlation coefficients using a 2-way random-effects model for the baseline, second, and third days.ResultsAdherence to the study on a daily basis outperformed cumulative adherence levels. The median proportion of adherence days (wearing time surpassed 90% of the day) stood at 92.1%, with an IQR spanning from 86.9% to 98.4%. However, at the cumulative level, 32% (7/22) of participants in this study exhibited lower adherence, with the device worn on fewer than 4 days within the requested initial 14-day period. Five physical activity measures have high variability for some participants. Consistent activity data for 4 physical activity measures might be attainable with just a 3-day period of device use.ConclusionsThis study revealed that while older adults generally showed high daily adherence to the wearable device, consistent usage across consecutive days proved difficult. These findings underline the effectiveness of wearables in monitoring physical activity in older populations and emphasize the ongoing necessity to simplify usage protocols and enhance user engagement to guarantee the collection of precise and comprehensive data.

Project description:BackgroundWe conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy.ObjectiveThis study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC.MethodsPotentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori.ResultsFrom 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal.ConclusionsThis pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required.Trial registrationClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716.

Dataset Information

The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial.

Rationale & objective

Study design

Setting & participants

Interventions

Outcome

Results

Limitations

Conclusion

Funding

Trial registration

Publications

The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets