Trial Outcomes & Findings for The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion (NCT NCT03170856)

Last Updated: 2023-01-31

Results Overview

Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

Measured at initial visit and 8-weeks.

Results posted on

2023-01-31

Participant Flow

Recruitment period: September 1, 2018 - November 1, 2020

Participant milestones

Participant milestones
Measure	Exercise Intervention Group Thse patients will undergo a sub-maximal exercise training as treatment for concussion. Sub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.	Usual Care Group These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Overall Study STARTED	20	21
Overall Study COMPLETED	17	20
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Intervention Group n=20 Participants Thse patients will undergo a sub-maximal exercise training as treatment for concussion. Sub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.	Usual Care Group n=21 Participants These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	17.3 years STANDARD_DEVIATION 1.9 • n=5 Participants	16.6 years STANDARD_DEVIATION 2.2 • n=7 Participants	16.9 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at initial visit and 8-weeks.

Population: Concussed participants who completed exercise testing at baseline and 8-week visits.

Outcome measures

Outcome measures
Measure	Concussed Participant Group n=28 Participants Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.	Usual Care Group These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. Baseline	0.031 cm s-1 mmHg-1/mmHg CO2 Standard Deviation 0.013	—
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. 8-week	0.028 cm s-1 mmHg-1/mmHg CO2 Standard Deviation 0.010	—

PRIMARY outcome

Timeframe: The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.

Population: Those who reported sufficient exercise volume information during the duration of the study.

Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).

Outcome measures

Outcome measures
Measure	Concussed Participant Group n=17 Participants Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.	Usual Care Group n=19 Participants These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. Initial	15 score on the PSCI scale Interval 10.0 to 42.0	20 score on the PSCI scale Interval 11.0 to 35.5
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. 4weeks post injury	4 score on the PSCI scale Interval 0.0 to 28.0	5.5 score on the PSCI scale Interval 0.5 to 21.5
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention. 8weeks post injury	6.5 score on the PSCI scale Interval 0.0 to 27.5	0 score on the PSCI scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Measured at initial visit and 8-week post injury visit.

Population: Participants enrolled in the study who completed exercise testing sessions at baseline and 8-week post injury.

Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.

Outcome measures

Outcome measures
Measure	Concussed Participant Group n=25 Participants Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.	Usual Care Group These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
End-tidal CO2 Baseline	33.4 mmHG Standard Deviation 3.0	—
End-tidal CO2 8-week	33.2 mmHG Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.

Population: Participants who completed exercise testing at baseline, 4-week, and 8-week follow-up visits.

Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.

Outcome measures

Outcome measures
Measure	Concussed Participant Group n=17 Participants Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.	Usual Care Group n=19 Participants These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Heart Rate 8-Week	170.2 beats per minute (bpm) Standard Deviation 8.1	167.4 beats per minute (bpm) Standard Deviation 12.3
Heart Rate Baseline Baseline	162.5 beats per minute (bpm) Standard Deviation 19	164.5 beats per minute (bpm) Standard Deviation 14.9
Heart Rate 4-Week	171.1 beats per minute (bpm) Standard Deviation 9.6	170 beats per minute (bpm) Standard Deviation 9.8

SECONDARY outcome

Timeframe: Average volume of exercise (min) that was self-reported by participants over the 8-week study period.

Population: Those who reported sufficient exercise volume information during the duration of the study.

Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period.

Outcome measures

Outcome measures
Measure	Concussed Participant Group n=17 Participants Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.	Usual Care Group n=20 Participants These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Volume of Self-reported Exercise Per Week	115 minutes Interval 54.0 to 225.0	88 minutes Interval 28.0 to 230.0

SECONDARY outcome

Timeframe: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic

Population: Those who reported RPE during initial, 4-week, and 8-week exercise tests.

Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working.

Outcome measures

Outcome measures
Measure	Concussed Participant Group n=17 Participants Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.	Usual Care Group n=19 Participants These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. baseline	15.8 units on a scale Standard Deviation 2.3	15.4 units on a scale Standard Deviation 1.7
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. 4-Week	16.7 units on a scale Standard Deviation 1.8	15.5 units on a scale Standard Deviation 1.9
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits. 8-Week	16.7 units on a scale Standard Deviation 1.9	15.1 units on a scale Standard Deviation 2.1

Adverse Events

Exercise Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Meehan

Boston Children's Hospital

Phone: 781-216-1328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place