Feasibility and Efficacy of the PRECISE DSS for Guiding Exercise Recommendation
R1: PRECISE Point-of-Care Decision Support Tool for Promoting Exercise and Recreation in People with Physical Disabilities
The translation of evidence into practice is a key factor underlying the successful adoption and maintenance of exercise behavior in people with physical disabilities. Unfortunately, healthcare providers lack the necessary decision support tools for expeditiously recommending to their patients to ‘precision-based’ exercise/recreation programs that haves a greater likelihood for achieving the target outcomes1. For healthcare providers to play a greater role in recommending exercise/recreation to their patients, time sensitive, decision support tools that provide lead to more ‘precise’ exercise/recreation recommendations and have a greater likelihood for promoting behavior change that results in higher rates of initiation (i.e., starting a new program), adherence, and improved health outcomes, are critically needed. This is the basis of the current D1 and R1 projects – that is, we seek to develop and evaluate the Precision-based Recreation & Exercise in Community Inclusive Settings and Environments Decision Support System (PRECISE DSS) through a multi-stage project involving feasibility and efficacy testing.
The aim of this R1 study is to test the feasibility and efficacy of the PRECISE DSS developed in the D1 project (Years 1-2) on a cohort of people with physical disabilities. The recommendations will target an identified domain of reduced physical function (e.g., lower extremity strength, balance, or walking) as a system-based approach for improving mobility.
To test the feasibility and efficacy of the PRECISE DSS for developing recommendations that will increase physical function in adults with physical disabilities.
Twenty-four participants will participate in the feasibility study and 48 participants in the efficacy study. People with one of the following diagnoses will be eligible for the study: MS, stroke, or Parkinson’s disease (PD). Eligibility criteria include: (a) age 18-64 years; (b) new member of Lakeshore Foundation; (c) willing and able to participate in a 4-month center-based exercise program; (d) non-exercisers (operationally defined as a health contribution score of less than 24 on the Godin Leisure Time Exercise Questionnaire; and (e) asymptomatic (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q) or physician approval for undertaking exercise training for those with 2 or more affirmatives on the PAR-Q. Participants who do not meet these criteria will be excluded from study participation. The sample of 24 is sufficient for providing valuable feasibility information for informing the subsequent pilot study.
The research will be conducted in Lakeshore Foundation’s health and fitness facility with newly enrolled members. The R1 project (Years 3-5) will involve two successive research phases.
Phase I will involve a feasibility study design for understanding the processes (e.g., recruitment rate), resources (e.g., retention rate), management (e.g., research site capacity), and scientific (e.g., safety and adverse events) outcomes of the PRECISE system developed in D1 when delivered through the staff at Lakeshore Foundation.
Participants will complete the items in the PRECISE DSS and receive output regarding a physiological profile, set of exercise recommendations, and strategies for exercise behavior change. Participants will then meet with a Lakeshore staff member who will assist them in undertaking the PRECISE recommendations in a 4-month exercise program.
Upon completion of the feasibility study, we will contact participants for feedback. Feedback will involve a successive two-pronged approach: a) completion of a mail-delivered survey containing questions for evaluation of the exercise program and its materials; and b) completion of a telephone interview for further evaluation of the program and its materials as well as participant experiences. The interviews will contain questions about expectations of the exercise program, perceptions of the process for enrolling in the program, actual experiences in the program (including any perceived benefits and problems experienced), and perceptions of interactions with research staff, materials, as well as any burden experienced from the PRECISE-generated exercise program.
Phase II will deploy a pilot randomized controlled trial for understanding the efficacy of the PRECISE system and refined during the feasibility phase for improving physiological function and walking outcomes in 48 participants with physical disability. Eligible participants who complete the baseline assessments will be randomly assigned to the PRECISE training program or to a usual care condition (standard membership orientation). Adherence to the PRECISE-based exercise recommendations and compliance with the exercise prescriptions will be examined.
Participants in the intervention group will receive their set of exercise recommendations from the modified (post-feasibility phase) PRECISE DSS. Participants in the usual care condition will go through the standard practice at Lakeshore Foundation, which involves an orientation of the facility, program overview, and general advice from a Lakeshore staff person. Participants in the intervention condition will then begin the PRECISE-generated exercise recommendations over the 4-month exercise period, while participants in the usual care condition will begin a 4-month, self-directed exercise program. Outcomes will be collected immediately upon completion of the 4-month period for participants in both conditions.
The primary outcome for this first phase of testing with the PRECISE DSS is physical function, which will be measured with the Short Physical Performance Battery. Walking performance will be assessed with the Timed 25-Foot Walk and the 6-Minute Walk Test.
Adherence (i.e., completion of the 4-month program) and compliance with the exercise training recommendations will be monitored based on personal logs and diaries as well as electronic records obtained when entering and leaving Lakeshore (i.e., membership card swipes).
Participants who receive the PRECISE-generated exercise recommendations will achieve greater gains in physical function (balance, strength and cardiorespiratory function) compared to a usual care group that receives a standard membership orientation upon joining a fitness center.
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