Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Brain Injury Clinical Trial

Official title:

Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710123
• Other study ID #: 030-690120
• Secondary ID: UL1TR001412
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: November 2023
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Description:

Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 1, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Adolescent with concussion injury from sports within first 10 days

Exclusion Criteria:

• Evidence of focal neurologic deficit; ADHD; history of moderate or severe TBI; greater than 3 prior concussions (or having history of long recovery from concussion, >3 mths); inability to understand English

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Concussion

Intervention

Other:
• Sub-Threshold exercise prescription
Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.
• Structured stretching prescription
Participants will be given a prescription for daily stretching lasting approximately 20 minutes.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in days) to recovery	Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)	2 to 180 days