Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Sponsor

University at Buffalo (Other)

Overall Status

Completed

CT.gov ID

NCT02710123

Collaborator

(none)

103

Enrollment

Location

Arms

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injury Concussion	Other: Sub-Threshold exercise prescription Other: Structured stretching prescription	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic Exercise Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription	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.
Placebo Comparator: Stretching Exercise Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.	Other: Structured stretching prescription Participants will be given a prescription for daily stretching lasting approximately 20 minutes.

Arm

Intervention/Treatment

Experimental: Aerobic Exercise

Participants will receive an exercise prescription based on their heart rate threshold (HRT) for symptom exacerbation during the Buffalo Concussion Treadmill Test (BCTT). The script will ask the participant to exercise one a day for 20 minutes at 80% of HRT. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Sub-Threshold exercise prescription

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.

Placebo Comparator: Stretching Exercise

Participants will receive a prescription for stretching exercises that they will be asked to do daily. Participants will wear a smart watch to monitor their frequency, actual time and HR during exercise. Treatment will continue until participant is fully recovered from their concussion. Intervention: Structured stretching exercise prescription.

Other: Structured stretching prescription

Participants will be given a prescription for daily stretching lasting approximately 20 minutes.

Outcome Measures

Primary Outcome Measures

Time (in days) to recovery [2 to 180 days]
Time (in days) to recovery (Recovery is asymptomatic+able to exercise to exhaustion without symptom exacerbation+judged recovered by MD with structured physical exam.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University at Buffalo	Buffalo	New York	United States	14214

Sponsors and Collaborators

University at Buffalo

Investigators

Principal Investigator: John Leddy, MD, University at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barry Willer, Professor, University at Buffalo

ClinicalTrials.gov Identifier:

NCT02710123

Other Study ID Numbers:

030-690120

First Posted:

Mar 16, 2016

Last Update Posted:

Aug 28, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Brain Injuries

Study Results

No Results Posted as of Aug 28, 2018