24 Participants randomised to the exercise DVD condition showed significant
improvements on the Short Physical Performance Battery (SPPB),25 as well as on measures of strength and upper and lower extremity flexibility. Additionally, this novel DVD-delivered intervention appears to be safe and well tolerated, Rucaparib AG-014699 with participants reporting high levels of satisfaction and a respectable rate of adherence, particularly for a home-based exercise programme (∼75% across the 6 months).24 It should be noted, however, that while participants experienced gains in measures of functional performance, the study sample still had arguably high levels of function at baseline. Older adults with MS would be expected to have more compromised levels of function than this healthier and higher functioning sample. Methods Study design and primary objectives The design is a two-arm, 6-month randomised controlled trial with participants randomised to either the FlexToBa DVD (ie, exercise) condition or a Healthy Aging DVD (ie, attentional control) condition (see figure 1). Stratified randomisation by age and sex will be conducted to ensure similar demographic characteristics between the two conditions
and to control for the potential influence of these covariates on study outcomes. The objective of this pilot trial is to test the efficacy of a DVD-delivered exercise intervention designed to enhance physical function (eg, mobility, strength and flexibility) in older adults with MS. Although this programme was initially developed for low-active, community-dwelling older adults,24 we believe that it may be appropriate for individuals with MS, as well, particularly given their limited engagement in physical activity and high degree of functional
limitations. Primary outcomes include physical function performance and QOL. We hypothesise that older adults with MS randomised to the exercise DVD condition will demonstrate improvements in markers of physical function (ie, flexibility, strength and balance), physical activity and QOL compared with participants assigned to the attentional control condition. Effect sizes generated from this pilot trial will assist in powering a future Drug_discovery definitive trial. Additionally, qualitative interviews will be conducted post-intervention to further assess participants’ attitudes towards physical activity and experience in the intervention. Figure 1 Study flow chart. Participants We will recruit 50 persons with MS who are aged 50 years and older throughout the state of Illinois and from western Indiana. This sample size was selected primarily due to the narrow time frame of the funding period, as well as to generate effect sizes for the primary outcomes.