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

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003712
Collaborator
(none)
10
1
1
12
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Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 30, 2023
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness Exercise Group

Subjects will participate in a one-month mindfulness breathing-exercise program

Behavioral: Mindfulness
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

Secondary Outcome Measures

  1. 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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami - Miami Project to Cure Paralysis Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami

Investigators

  • Principal Investigator: Mark Nash, PhD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark S. Nash, Ph.D., FACSM, Principal Investigator, University of Miami
ClinicalTrials.gov Identifier:
NCT06003712
Other Study ID Numbers:
  • 20230705
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023