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Respiratory Muscle Training for Spinal Cord Injury

N/A
Waitlist Available
Led By Alexander Ovechkin, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
sustained SCI at least 6 months prior to entering the study
no current anti-spasticity medication regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, after 1-month long respiratory training, and during 6 months of follow-up period
Awards & highlights

Study Summary

This trial will test whether resistive respiratory muscle training can improve blood pressure regulation in people with spinal cord injuries.

Eligible Conditions
  • Spinal Cord Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You had a spinal cord injury that happened at least 6 months ago.
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You are not currently taking any medication for muscle stiffness.
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You are in good health and do not have any medical conditions that would prevent you from receiving RMT.
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You do not have any significant mental health conditions such as depression or ongoing drug addiction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, after 1-month long respiratory training, and during 6 months of follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, after 1-month long respiratory training, and during 6 months of follow-up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Pulmonary Function Test outcomes
Secondary outcome measures
Changes in Orthostatic Stress Test outcomes
Changes in Respiratory Motor Control Assessment outcomes
Changes in cardiac output

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Respiratory Muscle TrainingExperimental Treatment1 Intervention
Each training session will last about 45-60 min and will occur five times weekly during one month. During the RMT sessions, the patient will remain in their personal wheelchair. They will be asked to breath through a special device with regulated resistance to breathing air. In the 20 sessions starting from the lowest resistance, the goal will be to train the muscles they use to breathe by slowly increasing this resistance. They will perform six work sets, 5 minutes in duration, separated by rest intervals lasting 1-3 minutes.
Group II: ControlActive Control1 Intervention
Following screening process and recruiting, subjects from both Healthy Control and SCI Control groups will undergo the same procedures as subjects from SCI group excluding the training intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Respiratory Muscle Training
2013
N/A
~140

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,815 Total Patients Enrolled
University of LouisvilleLead Sponsor
336 Previous Clinical Trials
75,880 Total Patients Enrolled
Alexander Ovechkin, MD, PhDPrincipal Investigatoravovec02@louisville.edu
3 Previous Clinical Trials
102 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the application process still open for potential participants in this research?

"Data hosted on clinicaltrials.gov indicates that this trial is not currently recruiting patients; however, it was initially posted in June of 2016 and last updated in March of 2022. Fortunately, there are 903 other medical studies actively searching for participants at the moment."

Answered by AI

Does this trial include adults over the age of 25?

"Adherent to the study's terms, any participants must be no younger than 18 years old and not exceed 80."

Answered by AI

Are there certain types of individuals who are better suited for this experiment?

"Eligibility criteria for this medical trial requires all participants to have spinal cord injuries and be between 18-80 years old. A total of 60 patients are being sought out for the study."

Answered by AI
~4 spots leftby Mar 2025