Autonomic dysfunction and physical activity a pathway to mitigating autonomic dysreflexia in spinal cord injury individuals

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:

INCLUSION CRITERIA

EXCLUSION CRITERIA

|1. Age above 18 to 65

2.  Both genders

3.  Individuals with SCI above the T6          level

4. Duration of Injury: Post 6 month             injury

5. Refrained from caffeine, alcohol,       cigarettes atleast 12 hours prior the    assessment

1.  Neurologic diseases other than SCI (such as polyneuropathy), previous genitourinary disease or operation

2. Use of any drugs that could influence hemodynamic measurements within 24 hours before testing.

3. Pregnancy

4. History of cardiovascular disease: cardiac      arrythmias

5.  Patients who would not be able to participate in the submaximal test.

f. Study Procedures:

Participants will undergo 2 key assessments to quantify physical activity levels:

Screening Physical Activity Level Questionnaire: PASIPD (Physical Activity Scale for Individuals with Physical Disabilities)

Submaximal Exercise Test: 6-minute push test

  |Participants will undergo Urodynamic Assessment (UDS)

  |Simultaneously heart rate variability device will be used by placing the chest electrodes with the interface and reading will be assessed via software known as haemat lab.

|Measurement of HRV, BP, HR & Time during the UDS will be monitored.

|Documentation of AD symptoms: Silent AD OR Symptomatic AD

  |Time frame- 30-45 minutes

|Interpretation of the data

 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.