STUDY PROTOCOL |
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Year : 2018 | Volume
: 3
| Issue : 4 | Page : 130-134 |
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Effects of a heel raise program on central hemodynamics and cognitive performance in chronic stroke: Study protocol for a randomized, controlled, crossover trial
Andrew Mitchelmore MSc 1, Danielle Lambrick2, Simon Jobson1, Lee Stoner3, James Faulkner1
1 Department of Sport, Exercise and Health, University of Winchester, Winchester, UK 2 Faculty of Health Sciences, University of Southampton, Southampton, UK 3 Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Correspondence Address:
Andrew Mitchelmore Department of Sport, Exercise and Health, University of Winchester, Winchester UK
Source of Support: None, Conflict of Interest: None | Check |
DOI: 10.4103/2542-3975.248012
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Background and objectives: As survival rates after incident stroke increase, the burden caused by secondary stroke and pressure placed on rehabilitation centers also rises. Lifestyle interventions have the potential to drive secondary-prevention treatments. Low-intensity interventions, such as heel raises, may offer a simple method of improving cardiovascular health and cognitive ability in chronic stroke. Here we present a protocol which attempts to determine whether a heel raise training program can improve markers of vascular health and cognitive function.
Design: A randomized, controlled, crossover trial.
Methods: Fifteen participants (> 3 months post-stroke diagnosis) will be randomly assigned to an intervention-first group (n = 8) or a control-first group (n = 7). In the intervention period, participants will complete 170 heel raises per day for 10 weeks. Heel raises will be completed in sets of ten, within a period of 170 minutes, from a seated position. In the control period, participants will go about their normal lives for 10 weeks. On completion of each program, participants will have a 4-week washout before commencing the alterative arm.
Outcome measures: The primary outcomes (pre- and post-measures of peripheral and central blood pressure and pulse wave velocity) will be recorded, as these variables are strongly linked to vascular health after stroke. Secondary outcomes (cognitive function and maximal voluntary contractions) will be assessed using the Stroop task and electromyography respectively. A mixed-model analysis of variance will identify whether a heel raise intervention has a significant effect on the proposed primary and secondary outcome variables.
Discussion: The potential improvements in vascular health may demonstrate that lower-limb heel raise exercise is a beneficial exercise stimulus for this population group.
Ethics and dissemination: The protocol received ethical approval from the University of Winchester Ethics Committee (approval No. BLS/17/11) on November 30, 2017 and will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. Recruitment began in June 2018. Analysis of the primary and secondary outcome measures will be completed in January 2019, and the study will finish in February 2019.
Trial registration: The study was registered with ClinicalTrials.gov (NCT03423433) on February 6, 2018.
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