Physical activity, function, and quality of life: design and methods of the FlexToBa trial

Abstract

The Flexibility, Toning, and Balance (FlexToBa) Trial is a two-armed randomized controlled trial which will contrast the effects of a DVD-delivered, home-based, physical activity intervention and a Healthy Aging attention control condition on physical activity, functional performance, functional limitations, and quality of life in low active, older adults. This innovative trial will recruit 300 participants across central Illinois who will be randomized into the intervention arm or control arm of the study. The intervention will last 6 months with a 6 month follow-up. Assessments at baseline, post intervention and follow-up will include physical activity (self-report and accelerometry), a battery of functional performance measures, functional limitations, quality of life, and an array of psychological health measures. In addition, measures of external validity will be included to determine public health significance of a successful outcome. Participants will engage in a progressive series of activities focusing on flexibility, strengthening, and balance exercises which are demonstrated by a trained exercise leader and age-appropriate models on a series of DVDs. Delivery of the intervention has its basis in social cognitive theory. The specific aims of the trial are (a) to determine the effects of the DVD-delivered FlexToBa program on physical activity, functional performance, functional limitations, and quality of life, (b) to examine the mediators of the relationships between physical activity and functional limitations and quality of life, (c) to assess external validity indicators relative to the intervention, and (d) to determine differential effects of the intervention on psychosocial health measures.

Trial registration: ClinicalTrials.gov NCT01030419.

Figure 1

FlexToBa™ Participant Flow-Chart