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M11 A randomised controlled feasibility trial of a physical activity behaviour change intervention compared to social interaction in huntington’s disease.Busse, Monica; Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; et al. (BMJ Publishing Group Ltd., 2016-09-13)Background Regular physical activity has health benefits for people with Huntington’s disease (HD), however consistent engagement is challenging. We report the results of a single blind, multi-site, randomised controlled feasibility trial of a physical activity intervention in HD. Methods Participants were randomly assigned to physical activity or social contact control interventions. The primary outcome was feasibility. Short-term benefit was assessed with the Physical Performance Test (PPT), a measure of functional ability. A range of exploratory outcomes including home and community mobility (Life Space), self-efficacy (Lorig), physical activity (International Physical Activity Questionnaire (IPAQ)), as well as disease-specific measures of motor and cognitive function were evaluated. Intervention fidelity and delivery costs were established. The trial was registered (ISRCTN 65378754 (13/03/2014)). Results We recruited 46 people with HD; 22 were randomised to the physical intervention (n = 16 analysed); 24 to social contact (n = 22 analysed). Retention, fidelity and adherence met pre-determined criteria. IPAQ scores in the physical intervention group were 142% higher (1.42; 95% CI: [−22%%, 653%]); and self-efficacy for exercise (1.6; 95% CI: [0.6, 2.7]) was also higher. Life Space scores were 12 points different between groups; 95% CI: [−2, 27]. Cognitive function was better in the physical intervention group with 2·9 more correct responses (95% CI: [0.01, 5.9]) on the Symbol Digit Modality test. There were no differences in other exploratory outcome measures and in particular no between-group differences in the PPT (treatment effect: 0.3, 95% CI: [−2.1, 2.7]). Mean (SD) physical intervention per session cost was £56.97 (£34.72). Conclusion A physical activity coaching intervention is feasible, can improve self-efficacy, physical activity behaviours and cognitive function in people with HD and represents excellent value for money in a devastating disease.
Optimising mobility outcome measures in Huntington's disease.Busse, Monica; Quinn, Lori; Khalil, Hanan; McEwan, Kirsten; Cardiff University; Jordan University of Science and Technology (IOS Press, 2014)Abstract. Background: Many of the performance-based mobility measures that are currently used in Huntington’s disease (HD) were developed for assessment in other neurological conditions such as stroke. Objective: We aimed to assess the individual item-response of commonly used performance-based mobility measures, with a view to optimizing the scales for speciﬁc application in Huntington’s Disease (HD). Method: Data from a larger multicentre, observational study were used. Seventy-ﬁve people with HD (11 pre-manifest & 64 manifest) were assessed on the Six-Minute Walk Test, 10-Meter Walk Test, Timed “Up & Go” Test (TUG), Berg Balance Scale (BBS), Physical Performance Test (PPT), Four Square Step Test, and Tinetti Mobility Test (TMT). The Uniﬁed Huntington’s Disease Rating Scale (UHDRS) Total Motor Score, Functional Assessment Scale and Total Functional Capacity scores were recorded, alongside cognitive measures. Standard regression analysis was used to assess predictive validity. Individual item responses were investigated using a sequence of approaches to allow for gradual removal of items and the subsequent creation of shortened versions. Psychometric properties (reliability and discriminant ability) of the shortened scales were assessed. Results: TUG ( 0.46, CI 0.20-3.47), BBS ( −0.35, CI−2.10-0.14), and TMT ( −0.45, CI−3.14-0.64) were good disease speciﬁc mobility measures. PPT was the best measure of functional performance ( 0.42, CI 0.00-0.43 for TFC & 0.57 CI 0.15-0.81 for FAS). Shortened versions of BBS and TMT were developed based on item analysis. The resultant BBS and TMT shortened scales were reliable for use in manifest HD. ROC analysis showed that shortened scales were able to discriminate between manifest and pre-manifest disease states. Discussion:OurdatasuggeststhatthePPTisappropriateasageneralmeasureoffunctioninindividualswithHD,andwehave identiﬁed shortened versions of the BBS and TMT that measure the unique gait and balance impairments in HD. These scales, alongside the TUG, may therefore be important measures to consider in future clinical trials.
Physical activity self-management and coaching compared to social interaction in huntington disease: results from the ENGAGE-HD randomized, controlled, pilot feasibility trial.Busse, Monica; Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; et al. (Oxford Academic, 2017-03-24)Abstract Background: Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective: We assessed feasibility and outcomes of a 14 week physical activity self-management and coaching intervention compared with social contact in Huntington's disease (HD) to inform the design of a future full-scale trial. Design: Assessor blind, multi-site, randomized pilot feasibility trial. Setting: Participants were recruited and assessed at baseline, 16 weeks following randomisation, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention: People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements: Eligibility, recruitment, retention and intervention adherence were determined at 16 weeks. Other outcomes of interest included measures of functional, home and community mobility, self-efficacy, physical activity and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results: Forty % (n=46) of eligible patients were enrolled and 22 randomised to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92% respectively. Minimum adherence criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between group treatment effects on function, however increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lends support to our pre-defined intervention logic model. Limitations: The use of self-report measures may have introduced bias. Conclusions: An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation.