Improving physical functional and quality of life in older adults with multiple sclerosis via a DVD-delivered exercise intervention: a study protocol.
Bottom Line: Data analysis will include a 2 (condition)×2 (time) mixed factor analysis of variance (ANOVA) that follows intent-to-treat principles, as well as an examination of effect sizes.Participants will take part in qualitative interviews about perspectives on physical activity and programme participation.Participants will be asked to read and sign a detailed informed consent document and will be required to provide a physician's approval to participate in the study.
Affiliation: Exercise Science Department, Bellarmine University, Louisville, Kentucky, USA.Show MeSH
Related in: MedlinePlus
Mentions: 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 definitive trial. Additionally, qualitative interviews will be conducted post-intervention to further assess participants’ attitudes towards physical activity and experience in the intervention.
Affiliation: Exercise Science Department, Bellarmine University, Louisville, Kentucky, USA.