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

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


PUBLIC HEALTH RELEVANCE
Physical activity is an important modifiable behavior that has enormous impacts on the health of persons with chronic lung and heart disease. An interactive, educational and motivational online platform which emphasizes mindful movement, together with in-person mind-body exercise classes, may be helpful to increase confidence to exercise and promote long-term physical activity.

CRITIQUE 1:
Significance: 2 Investigator(s): 1 Innovation: 2 Approach: 4 Environment: 1 Overall Impact: This study, proposed by experienced investigators, seeks to adapt an existing web-basee physical activity intervention to include mind-body principles for patients with COPD and heart failure (HF). This R34 grant aims to adapt the interventions into a web-based protocol and then to pilot test the intervention on 42 patients with COPD or HF. This intervention is novel and capitalizes on Dr. Yeh and Moy's previous research in web-based walking programs and Tai Chi. It is unclear exactly how these interventions will be adapted for a web-based program but if they are able to accomplish this, it would be highly impactful. The study is rigorously designed using tools that are both reliable and valid. The pilot data will provide needed data for an eventual R01 application. This project proposes to adapt an existing conventional web-based intervention by incorporating mindbody principles and Mind Body Exercises (MBEs) to develop a multimodal physical activity (PA) intervention for COPD and HF ("Mindful Steps") in older adults. This proposal was well written and organized. Study builds upon prior research with a well-developed PA web-based intervention that showed short-term benefit but waned by 12 months. Other research by the investigators showed that an in-person MBE (i.e. Tai Chi) intervention was successful at not only improving measures of PA but also important psychological variables such as self-efficacy and empowerment. This project will attempt to merge the two interventions together to deliver both content through an on-line and in person multimodal delivery system. Strengths of the project include a strong investigative team with relevant expertise and experience working together. Builds upon past prior research in relevant areas. Significance of the project is high since updating delivery models utilizing technology to decrease participant burden while simultaneously attempting to influence psychological health through the incorporation of MBE's could provide important information and infrastructure to further advance the field. In addition, the targeting of two similar chronic illnesses lends itself to generalizability and could impact a larger number of individuals. The incorporation of both traditional PA exercises along with more alternative MBE exercises lends itself to a novel integrated approach. Weaknesses include no junior faculty on team. Justification for utilizing a standard care control and for not utilizing power estimates is not considered scientifically sufficient. Measurement battery is large and could represent considerable participant burden. No information is given on how participants will be compensated for time and effort for assessments and whether procedures are in place to help older participants who could potentially have cognitive difficulties given the older age of the population to be recruited.

Significance:
Strengths  PA is an important modifiable behavior that has enormous impacts on the prognosis of Chronic obstructive pulmonary disease (COPD) and chronic heart failure (HF) and adherence to PA recommendations is frequently problematic.
 Psychosocial determinants such as depression, low self-efficacy, and low social support also contribute to low levels of PA in high-risk populations.
 Updating delivery models utilizing technology to decrease participant burden while simultaneously attempting to influence psychological health through the incorporation of MBE's could provide important knowledge and infrastructure to further advance the field.
 This stage of treatment development is justified before moving on to a larger randomized trial.

Weaknesses
 None noted

Investigator(s):
Strengths  Investigative team is excellent and has considerable experience in the population of interest.
 A team of well-known consultants with expertise in mind body principles and MBE interventions lend itself to project success.
 Team has extensive history of NIH funded projects.

Weaknesses
 Investigative team appears to be top heavy with more seasoned faculty. The inclusion of junior investigators would make the team more well-rounded.

Innovation:
Strengths  Investigating new delivery systems for MBE (i.e. home-based or web-based forums) in high risk populations has not been extensively studied.
 The incorporation of both traditional PA exercises along with more alternative MBE exercises lends itself to a novel integrated approach.

Weaknesses
 None noted

Approach: Strengths
 Based on formative pilot work highly relevant to the proposed project.
 Adaptation to come from existing treatments with prior research.
 Use of a multi-modal delivery system that still allows for some in-person contact.  The inclusion of a commercially-available pedometer (FitBit) to increase motivation as well as measurement.

Weaknesses
 The use of a standard care control weakens the interpretation of findings and is not well justified. Though the investigators describe alternative strategies they considered in regards to groups, stating that they chose the design based on limited resources is not scientifically sufficient.
 Though it is understood that treatment development projects typically under powered, effects sizes can be used as a benchmark of significance. No consideration to this issue was addressed and stating that the proposed sample size was based on time and costs is again not scientifically sufficient justification.
 The investigators state that the primary variables of interest include self-efficacy and overall physical activity level. However, the assessment battery consists of many other variables that seem to represent considerable burden to the participants.
 No information is given on how participants will be compensated for time and effort for assessments and whether procedures are in place to help older participants who could potentially have cognitive difficulties given the older age of the population to be recruited.
 No details are given as to whether FitBit sensors are able to effectively measure PA without bias or error.

Environment:
Strengths  The institutions are ideal for the proposed work.
 VA Boston Healthcare System appears to have sufficient recruitment resources.

Protections for Human Subjects:
Unacceptable Risks and/or Inadequate Protections  No information is given on how participants will be compensated for time and effort for assessments and whether procedures are in place to help older participants who could potentially have cognitive difficulties given the older age of the population to be recruited.

Budget and Period of Support:
Recommended budget modifications or possible overlap identified:  Project Coordinator and Research Assistant FTE seem a little low for project responsibilities.

Overall Impact:
This application aims to adapt an existing web-based intervention to incorporate mind-body practices to adults with COPD and HF. Given the large burden of these diseases, and lack of behavioral adherence to physical exercise, could have an major impact if mind-body practices improve upon the present intervention. The conceptual model presented for the rationale of the study and outcomes is excellent. The investigators are well poised to execute the research project based on prior work. Generally, the approach is rigorously designed as it relates to study design, recruitment, outcome selection, and proposed analyses. The comparison group does not advance or prepare the investigators for the next larger study. A comparison group that also uses an online platform and/or groups with time and attention matched would be more informative. This would be especially valuable given that the intervention under investigation is multimodal with possibly many active components/factors. 1 R34 AT009354-01 9 ZAT1 HS (28) YEH, G  Cardiopulmonary diseases produce significant morbidity with improvement in physical activity, and while exercise is helpful, adherence is poor. Improving adherence through technology and/or mind-body practices may be very beneficial.
 The study team has demonstrated use of web-based physical activity intervention and separately mind-body practices for this population. The objective of the grant is to deliver mindbody practices on this platform, which is a logical collaborative project.
 The theoretical framework presented as the rationale and conceptual model for the proposal is excellent and well presented.

Weaknesses
 It is a very practical approach to combine CHF and COPD for this grant and it is appreciated that a significant proportion of the population have both conditions. However, it is not clear if anything is lost by combining the two with regards to a targeted intervention, and/or measurement of outcomes.

Investigator(s):
Strengths  The investigators have substantial experience to conduct mind-body clinical trials, behavioral measurements, and develop and assess delivery of the intervention on the web-based platform.
Weaknesses  None noted.

Innovation:
Strengths  Online mind-body content for these specific populations has not been developed and rigorously evaluated.
 Supplementing usual care with mind-body practices to boost long-term adherence is novel Weaknesses  Outcomes selected are not particularly novel

Approach: Strengths
 Study design is organized in two phases of development and then testing which is appropriate and will more likely lead to successful implementation  Building mind-body practices into an existing intervention that is successful is practical and can evaluate potential value added from mind-body practices  Frequency of classes in-person versus online videos is part of research question for first phase and will allow for decision as to what dose and method of intervention delivery is appropriate.
1 R34 AT009354-01 10 ZAT1 HS (28) YEH, G Weaknesses  The intervention is multi-modal with various components which will make it difficult to determine which components were most helpful or useful  Investigators discuss that they considered other study designs for phase 2 including mind-body intervention versus conventional intervention versus usual care, but opted the present choice to see if patients were willing the be randomized. Given the substantial experience and prior studies of this group, they have demonstrated feasibility of randomization in other clinical trials. It is not clear why the present pilot would be different. Selection of a usual care group consisting of just educational materials will not provide substantial useful information. A more comparable intervention, preferably with time and attention matched and even method of delivery would be more informative. For example, in-person educational groups along with supplemented online content (such as the conventional intervention or even watered down) would be more informative. Also, a comparison group could have been selected to specifically prepare to compare an outcome of major interest in a future clinical trial; such as online engagement longterm or self-efficacy by the specific addition of mind-body practices to the existing conventional intervention.

Environment:
Strengths  The clinical centers and investigators are well-equipped to recruit this clinical population and implement the intervention Weaknesses  None noted.