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Rapid-Resistive Exercise Intervention (RET) for Traumatic Brain Injury

N/A

Waitlist Available

Led By Diane L Damiano, Ph.D.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Awards & highlights

Study Summary

This trial is looking at the effects of exercise on people with TBI, specifically problems with thinking, balancing, and moving, and depression or anxiety.

Eligible Conditions

Traumatic Brain Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)

Secondary outcome measures

Change in biomarkers

Change in cardiorespiratory fitness

Change in fatigue

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Rapid-Resistive Exercise Intervention (RET)Experimental Treatment1 Intervention

Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks

Group II: Aerobic Exercise Intervention (AET)Experimental Treatment1 Intervention

Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks

Group III: Waitlist Control (CON)Active Control1 Intervention

Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks

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Who is running the clinical trial?

Center for Neuroscience and Regenerative Medicine (CNRM)FED

23 Previous Clinical Trials

5,347 Total Patients Enrolled

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

881,178 Total Patients Enrolled

Diane L Damiano, Ph.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

9 Previous Clinical Trials

8,356 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must individuals meet in order to qualify for inclusion in this research project?

"This clinical research requires 100 participants between 18 and 79 to have sustained a non-penetrating traumatic brain injury more than one year prior. Additionally, the selected patients must be physically inactive as acknowledged by their physician, independent in ambulation without help, able to understand instructions related to this trial, and possess fluency in English with capacity for informed consent."

Answered by AI

How many subjects are being monitored in this research project?

"Absolutely. Clinical trials data confirms that this experiment, which was initially announced on December 15th 2016 is still recruiting patients. The requirement stands at 100 individuals from 2 sites."

Answered by AI

Can people who are under eighty years of age participate in this research project?

"The study has an age range of 18 to 79, while those below 18 and above 65 have 61 trials and 226 trials respectively."

Answered by AI

Is enrollment for this research study currently open to participants?

"Affirmative. Per the clinicaltrials.gov portal, this research is currently recruiting participants and was initially posted on December 15th 2016 before being updated most recently on November 4th 2022. As part of their search for subjects, 100 individuals need to be sourced from 2 distinct centres."

Answered by AI