Spinal Cord InjuriesNCT06003712
Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI)
A study testing Mindfulness in people with Spinal Cord Injuries and Quality of Life, run by University of Miami.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Quality of Life
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants taking medications that alter chronotropic and pressor responses will be excluded.
- Pregnant women will not be eligible to participate
About this study
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
The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI
- Conditions
- Spinal Cord Injuries, Quality of Life
- Being tested
- Mindfulness
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Exercise Group | Experimental | Subjects will participate in a one-month mindfulness breathing-exercise program Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 1 month
Secondary outcomes (1)
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"
Measured: baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: logistical staffing difficulties that affected recruitment and study conduct
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduard Tiozzo, PhD, University of Miami
- Investigators
- Eduard Tiozzo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003712
- Sponsor's protocol ID
- 20230705
- Status last verified
- May 2026
- First submitted
- 16 Aug 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06003712
- Acronym / sponsor ID
- 20230705
- Conditions
- Spinal Cord Injuries, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistical staffing difficulties that affected recruitment and study conduct
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Exercise Group | Experimental | Behavioral: MindfulnessSubjects will participate in a one-month mindfulness breathing-exercise program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants taking medications that alter chronotropic and pressor responses will be excluded.
- Pregnant women will not be eligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessParticipants 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. | Behavioural | Mindfulness Exercise Group |
Primary outcome
Change in Heart rate
Time frame: 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
Change in blood pressure
Time frame: 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)
Time frame: 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)
Time frame: 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
1 secondary outcome
Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
Time frame: baseline, 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Tiozzo, PhD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Spinal Cord Injuries and Quality of Life, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart rate (time frame: baseline, 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.