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Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol.

ABSTRACT: BACKGROUND:Persistent post-concussive symptoms (PPCS) affect up to 30% of individuals following mild traumatic brain injury. PPCS frequently includes exercise intolerance. Sub-symptom threshold aerobic exercise has been proposed as a treatment option for symptom burden and exercise intolerance in this population. The primary aim of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program can alleviate symptom burden in adults with PPCS. METHODS:Fifty-six adults (18-65) with PPCS (>3mos-5?yrs) will be randomized into two groups: an immediate start 12-week aerobic exercise protocol (AEP) or delayed start 6-week placebo-like stretching protocol (SP), followed by AEP. Aerobic or stretching activities will be completed 5x/week for 30 mins during the intervention. Online daily activity logs will be submitted. Exercise prescriptions for the AEP will be 70-80% of heart rate at the point of symptom exacerbation achieved on a treadmill test with heart rate monitoring. Exercise prescription will be updated every 3-weeks with a repeat treadmill test. The Rivermead Post-concussion Symptom Questionnaire will be the primary outcome measure at 6 and 12-weeks of intervention. Secondary outcomes include assessments of specific symptoms (headache, quality of life, mood, anxiety, fatigue, dizziness, sleep parameters, daytime sleepiness) in addition to blood biomarkers and magnetic resonance imaging and spectroscopy data for quantification of brain metabolites including ?-aminobutyric acid (GABA), glutathione, glutamate and N-acetyl aspartate (NAA) all measured at 6 and 12-weeks of intervention. DISCUSSION:This trial will evaluate the use of aerobic exercise as an intervention for adults with PPCS, thus expanding our knowledge of this treatment option previously studied predominantly for adolescent sport-related concussion. TRIAL REGISTRATION:ClinicalTrials.gov - NCT03895450 (registered 2019-Feb-11).

SUBMITTER: Mercier LJ

PROVIDER: S-EPMC7003424 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol.

Mercier Leah J LJ Fung Tak S TS Harris Ashley D AD Dukelow Sean P SP Debert Chantel T CT

BMC neurology 20200205 1

<h4>Background</h4>Persistent post-concussive symptoms (PPCS) affect up to 30% of individuals following mild traumatic brain injury. PPCS frequently includes exercise intolerance. Sub-symptom threshold aerobic exercise has been proposed as a treatment option for symptom burden and exercise intolerance in this population. The primary aim of this study is to evaluate whether a progressive, sub-symptom threshold aerobic exercise program can alleviate symptom burden in adults with PPCS.<h4>Methods</ ...[more]

PMID: 32024486

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Project description:Pediatric mild traumatic brain injury (pmTBI) has received increased public scrutiny over the past decade, especially regarding children who experience persistent post-concussive symptoms (PPCS). However, several methods for defining PPCS exist in clinical and scientific literature, and even healthy children frequently exhibit non-specific, concussive-like symptoms. Inter-method agreement (six PPCS methods), observed misclassification rates, and other psychometric properties were examined in large cohorts of consecutively recruited adolescent patients with pmTBI (n = 162) 1 week and 4 months post-injury and in age/sex-matched healthy controls (HC; n = 117) at equivalent time intervals. Six published PPCS methods were stratified into Simple Change (e.g., International Statistical Classification of Diseases and Related Health Problems, 10th revision [ICD-10]) and Standardized Change (e.g., reliable change indices) algorithms. Among HC, test-retest reliability was fair to good across the 4-month assessment window, with evidence of bias (i.e., higher symptom ratings) during retrospective relative to other assessments. Misclassification rates among HC were higher (>30%) for Simple Change algorithms, with poor inter-rater reliability of symptom burden across HC and their parents. A 49% spread existed in terms of the proportion of pmTBI patients "diagnosed" with PPCS at 4 months, with superior inter-method agreement among standardized change algorithms. In conclusion, the self-reporting of symptom burden is only modestly reliable in typically developing adolescents over a 4-month period, with additional evidence for systematic bias in both adolescent and parental ratings. Significant variation existed for identifying pmTBI patients who had "recovered" (i.e., those who did not meet individual criteria for PPCS) from concussion across the six definitions, representing a considerable challenge for estimating the true incidence rate of PPCS in published literature. Although relatively straightforward to obtain, current findings question the utility of the most commonly used Simple Change scores for diagnosis of PPCS in clinical settings.

Project description:BackgroundPersistent post-concussion symptoms (PPCS) affect between 34 and 46% after a mild traumatic brain injury (mTBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise, SSTAE (exercise at an intensity level that does not increase symptoms) is proposed as a treatment to both reduce the symptom burden and increase the exercise tolerance after the injury. It is unclear if this also applies in a more chronic phase after mTBI.Main purposeThe main purpose of this study is to evaluate whether SSTAE in addition to ordinary rehabilitation will lead to clinically meaningful improvement of symptom burden, normalize exercise tolerance, increase physical activity, improve health-related quality of life, and reduce patient-specific activity limitations compared to a control group that only receives ordinary rehabilitation.DesignRandomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1.MethodsPatients between the ages of 18 and 60 with exercise intolerance and persistent PPCS (> 3 months) will be recruited to the study and randomized to two groups. All patients will receive follow-up at the outpatient TBI clinic. The intervention group will in addition receive SSTAE for 12 weeks with exercise diaries and a retest every 3 weeks for optimal dosage and progression. The Rivermead post-concussion symptoms questionnaire will be the main outcome measure. The secondary outcome measure will be a test of exercise tolerance-the Buffalo Concussion Treadmill Test. Other outcome measures include the patient-specific functional scale that measures patient-specific activity limitations, as well as outcome measures for diagnosis-specific health-related quality of life, anxiety and depression, specific symptoms such as dizziness, headache and fatigue, and physical activity.DiscussionThis study will add knowledge about the effect of SSTAE and whether it should be implemented in rehabilitation for the adult population with persistent PPCS after mTBI. The nested feasibility trial showed that the SSTAE intervention was safe and that the study procedures and delivery of the intervention overall were feasible. However, minor amendments to the study protocol were made prior to the commencement of the RCT.Trial registrationClinical Trials.gov, NCT05086419. Registered on September 5th, 2021.

Project description:Background Being a newly emerging disease, little is known about its long-lasting post-COVID-19 consequences. The aim of this work is to assess the frequency, patterns, and determinants of persistent post-COVID-19 symptoms and to evaluate the value of a proposed novel COVID-19 symptom score. Patients with confirmed COVID-19 in a hospital-based registry were included in a cross-sectional study (the hospitals including Assiut University Hospital, Assiut Chest Hospital, Aswan University Hospital, and Aswan Specialized Hospital). The patient demographics, comorbid disorders, the mean duration since the onset of the symptoms, history of hospital or ICU admittance, and the treatment taken during the acute state, as well as symptom score before and after convalescence, were recorded. Results The most frequent constitutional and neurological symptoms were myalgia (60.0%), arthralgia (57.2%), restriction of daily activities (57.0%), and sleeping troubles (50.9%), followed by anorexia (42.6%), chest pain (32.6%), gastritis (32.3%), cough (29.3%), and dyspnea (29.1%). The mean total score of acute stage symptoms was 31.0 ± 16.3 while post-COVID 19 symptom score was 13.1 ± 12.6 (P < 0.001). The main determinants of the persistent post-COVID-19 symptoms were the need for oxygen therapy (P < 0.001), pre-existing hypertension (P = 0.039), chronic pulmonary disorders (P = 0.012), and any chronic comorbidity (P = 0.004). There was a correlation between the symptom score during the acute attack and post-COVID-19 stage (P < 0.001, r = 0.67). The acute phase score had 83.5% sensitivity and 73.3% specificity for the cutoff point > 18 to predict occurrence of post-COVID-19 symptoms. Conclusions COVID-19 can present with a diverse spectrum of long-term post-COVID-19 symptoms. Increased acute phase symptom severity and COVID-19 symptom score > 18 together with the presence of any comorbid diseases increase the risk for persistent post-COVID-19 manifestations and severity.

Project description:IntroductionMild traumatic brain injury (TBI) is a global public health concern that affects millions of children annually. Mild TBI tends to result in subtle and diffuse alterations in brain tissue, which challenges accurate clinical detection and prognostication. Diffusion tensor imaging (DTI) holds promise as a diagnostic and prognostic tool, but little research has examined DTI in post-acute mild TBI. The current study compared post-acute white matter microstructure in children with mild TBI versus those with mild orthopedic injury (OI), and examined whether post-acute DTI metrics can predict post-acute and chronic post-concussive symptoms (PCS).Materials and methodsChildren aged 8-16.99 years with mild TBI (n = 132) or OI (n = 69) were recruited at emergency department visits to two children's hospitals, during which parents rated children's pre-injury symptoms retrospectively. Children completed a post-acute (<2 weeks post-injury) assessment, which included a 3T MRI, and 3- and 6-month post-injury assessments. Parents and children rated PCS at each assessment. Mean diffusivity (MD) and fractional anisotropy (FA) were derived from diffusion-weighted MRI using Automatic Fiber Quantification software. Multiple multivariable linear and negative binomial regression models were used to test study aims, with False Discovery Rate (FDR) correction for multiple comparisons.ResultsNo significant group differences were found in any of the 20 white matter tracts after FDR correction. DTI metrics varied by age and sex, and site was a significant covariate. No interactions involving group, age, and sex were significant. DTI metrics in several tracts robustly predicted PCS ratings at 3- and 6-months post-injury, but only corpus callosum genu MD was significantly associated with post-acute PCS after FDR correction. Significant group by DTI metric interactions on chronic PCS ratings indicated that left cingulum hippocampus and thalamic radiation MD was positively associated with 3-month PCS in the OI group, but not in the mild TBI group.ConclusionsPost-acute white matter microstructure did not differ for children with mild TBI versus OI after correcting for multiple comparisons, but was predictive of post-acute and chronic PCS in both injury groups. These findings support the potential prognostic utility of this advanced DTI technique.

Project description:BackgroundAerobic exercise has emerged as a useful treatment to improve outcomes among individuals who experience a concussion. However, compliance with exercise recommendations and the effect of exercise volume on symptom recovery require further investigation.PurposeTo examine (1) if an 8-week aerobic exercise prescription, provided within 2 weeks of concussion, affects symptom severity or exercise volume; (2) whether prescription adherence, rather than randomized group assignment, reflects the actual effect of aerobic exercise in postconcussion recovery; and (3) the optimal volume of exercise associated with symptom resolution after 1 month of study.Study designCohort study; Level of evidence, 2.MethodsIndividuals randomized to an exercise intervention (n = 17; mean age, 17.2 ± 2.0 years; 41% female; initially tested a mean of 11.3 ± 2.8 days after injury) or standard of care (n = 20; mean age, 16.8 ± 2.2 years; 50% female; initially tested a mean of 10.7 ± 3.2 days after injury) completed an aerobic exercise test within 14 days of injury. They returned for assessments 1 month and 2 months after the initial visit. The aerobic exercise group was instructed to exercise 5 d/wk, 20 min/d (100 min/wk), at a target heart rate based on an exercise test at the initial visit. Participants reported their exercise volume each week over the 8-week study period and reported symptoms at each study visit (initial, 1 month, 2 months). Because of low compliance in both groups, there was no difference in the volume of exercise between the 2 groups.ResultsThere were no significant symptom severity differences between the intervention and standard-of-care groups at the initial (median Post-Concussion Symptom Inventory, 15 [interquartile range = 10, 42] vs 20 [11, 35.5]; P = .26), 1-month (4 [0, 28] vs 5.5 [0.5, 21.5]; P = .96), or 2-month (6.5 [0, 27.5] vs 0 [0, 4]; P = .11) study visits. Exercise volume was similar between groups (median, 115 [54, 225] vs 88 [28, 230] min/wk for exercise intervention vs standard of care; P = .52). Regardless of group, those who exercised <100 min/wk reported significantly higher symptom severity at the 1-month evaluation compared with those who exercised ≥100 min/wk (median, 1.5 [0, 7.5] vs 12 [4, 28]; P = .03). Exercising ≥160 min/wk successfully discriminated between those with and those without symptoms 1 month after study commencement (classification accuracy, 81%; sensitivity, 90%; specificity, 78%).ConclusionGreater exercise volume was associated with lower symptom burden after 1 month of study, and an exercise volume >160 min/wk in the first month of the study was the threshold associated with symptom resolution after the first month of the study. Because our observation on the association between exercise volume and symptom level is a retrospective and secondary outcome, it is possible that participants who were feeling better were more likely to exercise more, rather than the exercise itself driving the reduction in symptom severity.

Dataset Information

Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol.

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Improving symptom burden in adults with persistent post-concussive symptoms: a randomized aerobic exercise trial protocol.

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