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The effect of graduated return to high-intensity exercise on time to return to play in the context of sports-related concussions.

A pilot study to determine the effect of the early introduction of graduated return to either low or high-intensity exercise in the early recovery phase of concussion on symptoms and time to return to play.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000485235
Enrollment
50
Registered
2018-04-04
Start date
2018-05-01
Completion date
2018-08-31
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A sports-related concussion (SRC) is defined as a traumatic brain injury (TBI) induced by biomechanical forces which results in a functional, rather than structural injury. This is reflected by the fact that standard clinical imaging is normal while a graduated set of clinically measurable concussion symptoms manifest within seconds to hours (McCrory et al., 2017). Other measurable changes have been found previously; such as acute and chronic changes in cerebral blood flow (CBF), cerebral oxygen consumption, neurovascular coupling (NVC), and autoregulation of blood pressure (BP) (Werner & Engelhard, 2007; Wright, Smirl, Bryk, & van Donkelaar, 2017). Furthermore, there is recent unpublished work from the Dunedin School of Medicine which shows a relationship between rugby players having a history of concussions and an impaired olfactory ability (Osborne etal 2016, Perez, 2017). It has long been shown that graduated exercise to high intensity is a useful tool for rehabilitating delayed symptoms of concussion, in both the short-term and the long term (Leddy et al., 2018; Leddy et al., 2010; Leddy & Willer, 2013; Silverberg & Iverson, 2013). However, it is only since the most recent international guidelines were published last year that the advice has now changed from “complete rest until you’re recovered” to incorporating “low levels of activity into early recovery” (McCrory et al., 2017; McCrory et al., 2013). Nevertheless, it is the increasing of levels of activity that has been shown to cause the resolution of symptoms compared with resting (Leddy et al., 2018; Leddy & Willer, 2013). The following proposed research is a pilot study which aims to show that the early introduction of graduated return to either low or high intensity exercise is safe and not worse than the outcomes published in the consensus statement of the 5th international conference on concussion in sport (McCrory et al., 2017). Patients with sport related concussion will be recruited and baseline tests done of symptoms of concussion, balance, smell, CBF, cerebral oxygen consumption and exercise induced symptom tolerance. Players will be randomised to either graduated return to low intensity or high intensity physical activity till symptoms resolve and then they will be reassessed with the battery of tests. The hypothesis that the set of symptoms found at the beginning should have resolved by the end, both clinically and also with the other sub-symptomatic physiological tests.

Interventions

The graduated return to high-intensity exercise (intervention) arm will involve athletes doing a daily two-stage aerobic exercise regime. This will begin on the first day with a ten-minute walk and, if this does not lead to a worsening of symptoms, will be followed by ten minutes of exercise at an increased intensity (e.g. brisk walk). On the second day, the first ten minute period will be matching that of the second ten minute period from the previous day. If this does not lead to worsening of

The graduated return to high-intensity exercise (intervention) arm will involve athletes doing a daily two-stage aerobic exercise regime. This will begin on the first day with a ten-minute walk and, if this does not lead to a worsening of symptoms, will be followed by ten minutes of exercise at an increased intensity (e.g. brisk walk). On the second day, the first ten minute period will be matching that of the second ten minute period from the previous day. If this does not lead to worsening of concussion symptoms they will increase the intensity again for the second ten minutes. If an increase in intensity leads to a worsening of symptoms, the patient will be instructed to return to the intensity that they last used which lead to no increase in symptoms. If the symptom exacerbation continues then the participant will be instructed to rest for the rest of the day. This will continue from day 3 post-injury until the patients report being symptom-free, or day 14 (whichever occurs first). For all participants who are aged 13-18, they will report to the clinic on injury day 14, whether or not they become symptom-free earlier. The exercise will be unsupervised, individual exercise which will be following a protocol administered by Dr Hamish Osborne, a qualified sports physician. It is not feasible to have athletes under daily supervision for exercise, and there is no evidence to suggest that it is unsafe to let the athletes exercise alone. All patients will be reviewed clinically every 14 days until resolution of symptoms or sooner during that 14-day cycle if their symptoms resolve. Adults will have the repeated battery of physiological testing done at 14 days or sooner if symptoms resolve. Those still with symptoms at 14 days will be retested on resolution of symptoms or at 42 days whichever is sooner. Adolescent patients will be retested at resolution of symptoms or 42 days whichever is sooner. Participants will be asked to keep a short exercise diary. This will entail them simply stating the times at which they exercise and providing a simple summary of it (e.g. how did it feel? Did it feel any different from previous days? If so, how is it different?) The initial intervention is only occurring for the first 14 days. However, from here, if they are medically cleared, they will progress on to complete the rest of the standardised graduated return to play protocol, as stipulated by ACC (regardless of group). If they are not yet medically cleared, Dr Osborne will advise them on how they can manage their symptoms.

Sponsors

Dr Hamish Osborne
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients diagnosed with a sports-related concussion in the Emergency Department at Dunedin Public Hospital or at the Otago Sports Injury Clinic Able to give informed consent or, if under 18 years of age, gain written consent from legal guardian (as well as signing a consent form for themselves). Be able to attend three follow up sessions in outpatient concussion clinic.

Exclusion criteria

Co-occurring orthopaedic injury which impairs ability to exercise Any other contraindications or risk factors to exercise (e.g. cardiac conditions). Co-occurring mental health concerns or learning disabilities that would prevent them from understanding instructions or completing a graduated return to learning/school regime in a normally expected amount of time. Diagnosis of a severe TBI, or a concussion severe enough to result in an admission to hospital.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026