1.       Title: AUTONOMIC DYSFUNCTION AND PHYSICAL ACTIVITY: A PATHWAY TO MITIGATING AUTONOMIC DYSREFLEXIA IN SPINAL CORD INJURY INDIVIDUALS

2.       Background/Introduction/Review of Literature:

The idea to explore the impact of physical activity on heart rate variability (HRV) during Urodynamic assessment (UDS) in spinal cord injury (SCI) patients arose while considering the challenges of managing Autonomic Dysreflexia (AD), a life-threatening condition often triggered by UDS in individuals with SCI above the T6 level. AD, characterized by sudden and severe hypertension, is a medical emergency linked to autonomic dysfunction. Previous studies highlight that HRV is a valuable tool for assessing autonomic function, and abnormal HRV may serve as an early marker for AD onset. Regular physical activity has been proven to enhance parasympathetic activity and improve HRV, potentially reducing AD episodes. However, no studies have specifically investigated how physical activity influences HRV during UDS in SCI patients, particularly concerning AD. This protocol aims to address this gap, offering critical insights into improving autonomic regulation and patient safety during UDS.

3.       Objectives and Hypothesis

Objectives:

To determine the effect of physical activity on HRV and the occurrence & Severity of AD episodes during urodynamic assessments in SCI patients.

Hypothesis:

Null Hypothesis (Hâ‚€):
Physical activity has no significant impact on HRV and the occurrence & Severity of AD episodes during urodynamic assessments in SCI patients.

Alternative Hypothesis (H₁):
Physical activity has significant impact on HRV and the occurrence & severity of AD episodes during urodynamic assessments in SCI patients.

4.    Material and Methods

a.       Study Design: Cross-sectional study

b.      Sample size and method:

Sample size : The sample size for this study has been determined to be 15 participants. The prevalence of Autonomic Dysreflexia (AD) in spinal cord injury (SCI) patients is observed to be 80% among individuals with neurogenic detrusor overactivity. This data is derived from the study conducted by Alsulihem A et al in 2019.

Sampling method :  Purposive sampling

c.       Enrolment period:

d.      Total Study duration: 6-8 months

e.       Inclusion and exclusion criteria:

f.        Study Procedures:

g.       Assessment tools: HRV Device (Shimmer, Heartware), 6 minute push test

5.       Statistical Analysis Plan (SAP): Descriptive analysis will be conducted using mean, median, and standard deviation (SD) for heart rate variability (HRV), blood pressure (BP), heart rate (HR), and vesical pressure. Frequency and percentage will be used to analyse Autonomic Dysreflexia (AD) events, distinguishing between symptomatic and silent AD. The relationship between physical activity and HRV will be evaluated using ANOVA with multiple comparisons. The association between AD and HRV will be measured via Spearman correlation. Logistic regression will be employed to predict AD events based on HRV. All statistical analyses will be performed using SPSS 21 software.