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

Not Applicable

Not yet recruiting

• Conditions: Quality of Life; Spinal Cord Injuries
• Interventions: Behavioral: Mindfulness

• Registration Number: NCT06003712
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-19
• Last Update Posted: 2025-04-24
• Study Start: 2025-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness Exercise Group	Mindfulness	Subjects will participate in a one-month mindfulness breathing-exercise program

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	baseline, 1 month	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
Change in metabolism as measured by maximum oxygen consumption (VO2)	baseline, 1 month	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
Change in metabolism as measured by ventilation (VE)	baseline, 1 month	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
Change in Heart rate	baseline, 1 month	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

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III	baseline, 1 month	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"

Trial Locations

Locations (1)

University of Miami - Miami Project to Cure Paralysis; 🇺🇸 Miami, Florida, United States