NCT06003712

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
2.9 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

August 16, 2023

Last Update Submit

February 26, 2026

Conditions

Quality of LifeSpinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III

    baseline, 1 month

Study Arms (1)

Mindfulness Exercise Group

EXPERIMENTAL

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

Behavioral: Mindfulness

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness Exercise Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants taking medications that alter chronotropic and pressor responses will be excluded.
  • Pregnant women will not be eligible to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami - Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eduard Tiozzo, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Jones

CONTACT

(904) 325-4707cyj323@med.miami.edu

Kayla Samimi

CONTACT

(310) 855-44332kxs3301@med.miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)