Dataset Information

Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind-body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior.

Objective

This study aims to develop a novel multimodal mind-body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind-body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF.

Methods

In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind-body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind-body exercise classes, an educational website, online mind-body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures.

Results

The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019.

Conclusions

Through the integration of components from a web-based physical activity intervention and mind-body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach.

Trial registration

ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780.

International registered report identifier (irrid)

DERR1-10.2196/27826.

SUBMITTER: Litrownik D

PROVIDER: S-EPMC8120426 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Rationale & objectivePatients receiving dialysis report very low physical activity. We implemented a pilot trial to assess the feasibility of a pedometer-based intervention to gather preliminary evidence about its impact on physical activity, symptoms, and surrogates of cardiovascular risk.Study designPilot randomized controlled trial.Setting & participants60 dialysis patients from San Francisco dialysis clinics.InterventionParticipants were randomly assigned 1:1 to receiving pedometers with weekly step goals or usual care for 3 months.OutcomesThe primary outcome was step counts, measured using pedometers. Secondary outcomes included physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk. Targeted enrollment was 50% and targeted completion was 85%.Results49% of approached patients were enrolled, and 92% completed the study. After 3 months, patients randomly assigned to the intervention (n=30) increased their average daily steps by 2,256 (95% CI, 978-3,537) more than the 30 controls (P<0.001). Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05). There were no statistically significant differences across intervention groups in symptoms, physical performance, or endothelial function. Participants in the intervention group reverted to baseline steps during the postintervention follow-up.LimitationsThe Northern California study setting may limit generalizability. Walking does not capture the full spectrum of physical activity.ConclusionsA short-term pedometer-based intervention led to increased step counts in dialysis patients, but the increase was not sustained. Pedometer-based interventions are feasible for dialysis patients, but future studies are needed to address whether more prolonged interventions can improve physical function or symptoms.FundingSupported by grants from the American Kidney Fund, National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases, and International Society of Nephrology.Trial registrationRegistered at ClinicalTrials.gov with study identifier NCT02623348.

Project description:ImportanceBecause shopping malls are considered safe places for walking, several mall walking programs have been developed. Research on the association between the use of walking programs and the number of daily steps taken is limited.ObjectiveTo evaluate the association between use of a smartphone-based shopping mall walking program and daily steps taken after the COVID-19 pandemic.Design, setting, and participantsThis cohort study evaluated a nationwide longitudinal data set of 217 344 registered smartphone app users at least 18 years of age residing in Japan. Daily step counts were collected from January 1 to December 31, 2021.ExposuresThe mall walking program Mall Challenge integrated a global positioning system with a smartphone app's incentive system to reward achieving a goal of 1000 daily steps with lottery-based coupons to win from 0 to 500 shopping points (1 point equaled 1 yen or approximately US $0.01).Main outcomes and measuresDaily step records were collected from the smartphone app's walking program and adjusted for gender and age. Multilevel analyses using mixed-effect linear regression models were used to estimate the coefficients for the association between daily participation in the walking program and daily step counts. Cross-level interaction terms of age and gender by walking program participation were included in one model.ResultsAmong the 217 344 registered mall app users (23 638 110 daily step records; 154 616 [71.1%] women; 18 014 [8.3%] participants 65 years or older, and 199 330 [91.7%] adults younger than 65 years), the mean (SD) daily steps were 7415 (4686) on walking program participation days and 5281 (4339) on days without participation in the program. Walking program participation days were associated with 1219 additional daily steps (95% CI, 1205-1232) compared with nonparticipation days after adjusting for gender and age. By geographic region, participation in the walking program was associated with 1130 (95% CI, 1113-1146) more steps in rural malls, 1403 (95% CI, 1379-1428) more steps in suburban malls, and 1433 (95% CI, 1408-1457) more steps in urban malls than nonparticipation. Moreover, participation in the walking program was associated with 1422 (95% CI, 1405-1439) more steps in large malls and 1059 (95% CI, 1041-1077) more steps in small malls compared with nonparticipation. Regarding cross-level interactions, women were associated with walking 728 (95% CI, 698-758) more steps than men, and older adults were associated with walking 228 (95% CI, 183-273) more steps than younger adults on walking program participation days.Conclusions and relevanceThis cohort study found that the use of a smartphone-based mall walking program combined with physical shopping mall facilities and lottery-based digital incentive coupons may motivate people to increase their daily number of walking steps.