Back to resultsExploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)
Primary Purpose
Spinal Cord Injuries, Quality of Life
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
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
Sites / Locations
- University of Miami - Miami Project to Cure Paralysis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness Exercise Group
Arm Description
Subjects will participate in a one-month mindfulness breathing-exercise program
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
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"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06003712
Brief Title
Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Exercise Group
Arm Type
Experimental
Arm Description
Subjects will participate in a one-month mindfulness breathing-exercise program
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heart rate
Description
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
Time Frame
baseline, 1 month
Title
Change in blood pressure
Description
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
Time Frame
baseline, 1 month
Title
Change in metabolism as measured by maximum oxygen consumption (VO2)
Description
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
Time Frame
baseline, 1 month
Title
Change in metabolism as measured by ventilation (VE)
Description
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
Time Frame
baseline, 1 month
Secondary Outcome Measure Information:
Title
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
Description
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"
Time Frame
baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Jones
Phone
(904) 325-4707
Email
cyj323@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Samimi
Phone
(310) 855-44332
Email
kxs3301@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nash, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami - Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)
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