Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI

Official Title
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Exploring the Effects of a Mindfulness-Based Intervention on Physiologic and Quality of Life Markers in Individuals With Spinal Cord Injury (SCI): A Pre-post Test Design

Conditions
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Spinal Cord Injuries, Quality of Life

Intervention / Treatment
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* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females aged 18-70 who are living with spinal cord injury C5 to the T10 levels Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A-D Eligible participants must be able to understand and provide consent, be in good health operationalized as free from acute treatable illness, pressure injury, and cardiovascular disease. Exclusion Criteria: Participants taking medications that alter chronotropic and pressor responses will be excluded. Pregnant women will not be eligible to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Exercise Group<br>Subjects will participate in a one-month mindfulness breathing-exercise program | Behavioral: Mindfulness<br>* Participants will engage in a 10-15 minute mindfulness exercise three times weekly for one month. This mindfulness exercise utilizes guided attention on the breath through an instructional video, aiming to cultivate calmness and alleviate stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart rate | heart rate will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. Heart rate will be recorded in beats per minute | baseline, 1 month | 
| Change in blood pressure | Blood pressure (BP) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. BP will be collected as systolic over diastolic in mmHg units | baseline, 1 month | 
| Change in metabolism as measured by maximum oxygen consumption (VO2) | Metabolism as determined by oxygen consumption (VO2) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VO2 is collected as mL/kg/min | baseline, 1 month | 
| Change in metabolism as measured by ventilation (VE) | Metabolism as determined by oxygen consumption (VE) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VE is measured in L/min | baseline, 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III | A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from 1- very satisfied to 6-very dissatisfied. On the important section scoring ranges from 1-very important to 6- very unimportant | baseline, 1 month |