The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial

Trials, Jun 2016

Background Spinal cord injury (SCI) creates a complex pathology that can lead to an increase in sedentary behaviours and deleterious changes in body composition. Consequently, individuals with SCI are at increased risk of developing cardiovascular disease and type-2 diabetes mellitus. While the role of physical activity on the reduction of chronic disease risk is well documented in non-disabled individuals the evidence is less conclusive for persons with SCI. The aim of this methodological paper is to outline the design of a study that will assess the role of a home-based exercise intervention on biomarkers of metabolic and cardiovascular health in persons with SCI: the HOMEX-SCI study. Methods/design Eligible participants will be inactive (physical activity level ≤1.60) individuals, with a chronic (more than 1 year) spinal cord lesion between the second thoracic and the fifth lumbar vertebrae, and aged between 18 and 65 years. Following baseline laboratory testing and lifestyle monitoring, participants will be randomly allocated to a control (CON) group or a 6-week home-based exercise intervention (INT) group. The INT consists of 45 minutes of moderate-intensity (60–65 % peak oxygen uptake) arm-crank exercise four times per week. Participants assigned to the CON group will be asked to maintain their normal lifestyle. The main outcomes of this study (biomarkers of metabolic and cardiovascular health) are obtained from venous blood samples, collected in the fasted and postprandial state. Eight other measurement categories will be assessed: (1) body composition, (2) physical activity, (3) energy intake, (4) measures of health and wellbeing, (5) resting metabolic rate, heart rate and blood pressure, (6) aerobic capacity, (7) immune function, and (8) adipose tissue gene expression. Discussion This study will explore the feasibility of home-based moderate-intensity exercise and ascertain its impact on metabolic and cardiovascular health in comparison to a lifestyle maintenance CON group. Findings from this study may help to inform new evidence-based physical activity guidelines and also help to elucidate the physiological mechanisms whereby exercise might exert beneficial effects in persons with chronic SCI. The results will also act as a scientific platform for further intervention studies in other diverse and at-risk populations. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN57096451. Registered on 11 July 2014.

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The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial

Nightingale et al. Trials The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial Tom E. Nightingale 0 Jean-Philippe Walhin 0 James E. Turner 0 Dylan Thompson 0 James L. J. Bilzon 0 0 Department for Health, University of Bath , BA2 7AY Bath , UK Background: Spinal cord injury (SCI) creates a complex pathology that can lead to an increase in sedentary behaviours and deleterious changes in body composition. Consequently, individuals with SCI are at increased risk of developing cardiovascular disease and type-2 diabetes mellitus. While the role of physical activity on the reduction of chronic disease risk is well documented in non-disabled individuals the evidence is less conclusive for persons with SCI. The aim of this methodological paper is to outline the design of a study that will assess the role of a home-based exercise intervention on biomarkers of metabolic and cardiovascular health in persons with SCI: the HOMEX-SCI study. Methods/design: Eligible participants will be inactive (physical activity level ≤1.60) individuals, with a chronic (more than 1 year) spinal cord lesion between the second thoracic and the fifth lumbar vertebrae, and aged between 18 and 65 years. Following baseline laboratory testing and lifestyle monitoring, participants will be randomly allocated to a control (CON) group or a 6-week home-based exercise intervention (INT) group. The INT consists of 45 minutes of moderate-intensity (60-65 % peak oxygen uptake) arm-crank exercise four times per week. Participants assigned to the CON group will be asked to maintain their normal lifestyle. The main outcomes of this study (biomarkers of metabolic and cardiovascular health) are obtained from venous blood samples, collected in the fasted and postprandial state. Eight other measurement categories will be assessed: (1) body composition, (2) physical activity, (3) energy intake, (4) measures of health and wellbeing, (5) resting metabolic rate, heart rate and blood pressure, (6) aerobic capacity, (7) immune function, and (8) adipose tissue gene expression. Discussion: This study will explore the feasibility of home-based moderate-intensity exercise and ascertain its impact on metabolic and cardiovascular health in comparison to a lifestyle maintenance CON group. Findings from this study may help to inform new evidence-based physical activity guidelines and also help to elucidate the physiological mechanisms whereby exercise might exert beneficial effects in persons with chronic SCI. The results will also act as a scientific platform for further intervention studies in other diverse and at-risk populations. Trial registration: International Standard Randomised Controlled Trial Number: ISRCTN57096451. Registered on 11 July 2014. Aerobic capacity; Metabolic health; Paraplegia; Spinal cord injury; Physical activity; Immune function; Inflammation; Gene expression; Exercise intervention Background A spinal cord injury (SCI) is a significant life-changing event which has wide-ranging implications for multiple physiological systems. There are no reliable estimates of the global prevalence of SCI, perhaps reflecting the need for improvements in international medical standards and guidelines for reporting SCI. Over the past 60 years there has been a worldwide improvement in the acute survival of patients with traumatic SCI through the possibility of rapid transportation to a specialised unit, medical treatment advancements and improved rehabilitation [ 1 ]. As a consequence there has been a shift in focus from acute life support medicine, to addressing other secondary health complications and comorbidities associated with ageing with paralysis [ 2, 3 ]. Consequently the long-term demands on medical and support resources are high. A recent systematic review examining survival worldwide after SCI concluded that overall mortality in SCI is up to three times higher than in the general population [4]. Evidence now suggests that cardiovascular disease (CVD) is the leading cause of mortality in individuals with chronic SCI [ 5 ]. Besides CVD, epidemiological studies have also revealed the incidence of type-2 diabetes mellitus (T2DM) to be high in individuals with SCI [ 6–8 ]. Indeed, it has been suggested that adults with SCI are four times more likely to develop T2DM than non-disabled controls [ 9 ]. The contribution of regular physical activity (PA) to reduce the risk of these chronic diseases is well documented and broadly accepted in the non-disabled population [ 10, 11 ]. In individuals with SCI, involvement in sports and recreation is often restricted by the loss of voluntary motor control, as well as autonomic dysfunction and early onset of skeletal muscle fatigue [ 12–14 ]. There are also numerous psychosocial and environmental barriers: reduced self-esteem, lack of accessible facilities, unaffordable eq (...truncated)


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Tom Nightingale, Jean-Philippe Walhin, James Turner, Dylan Thompson, James Bilzon. The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial, Trials, 2016, pp. 284, 17, DOI: 10.1186/s13063-016-1396-z