Sub-symptom threshold aerobic exercise for patients with persisting post-concussion symptoms and exercise intolerance after mild traumatic brain injury - a study protocol with a nested feasibility study for a randomized controlled trial.

BACKGROUND: Persistent 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 PURPOSE: The 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. DESIGN: Randomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1. METHODS: Patients 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. DISCUSSION: This 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 REGISTRATION: Clinical Trials.gov, NCT05086419. Registered on September 5th, 2021.

The effectiveness of a family-centred intervention after traumatic brain injury: A pragmatic randomised controlled trial.

OBJECTIVES: To determine the effectiveness of a family-centred intervention for patients with traumatic brain injury and family members. DESIGN: Open-labelled, two-armed randomised controlled trial. SETTINGS: Outpatient clinic and family residences. PARTICIPANTS: Sixty-one patients (33 women) with traumatic brain injury, with mean (SD) age 43.8 (12.2), and 63 family members (33 women), with mean (SD) age 42.6 (11.3), were assign to intervention (n = 30 families) and control group (n = 31 families). INTERVENTION: An eight-session single-family intervention to improve individual and family functioning. OUTCOME MEASURES: Self-reported questionnaires at start-of-treatment, median (IQR) 11.4 (8.4, 15.9) months post-injury, and at two follow-ups, 2.7 (2.3, 3.8) and 9.2 (8.2, 9.9) months after start-of-treatment. Primary outcome measures were the SF-36 Mental Component Summary (MCS) and Caregiver Burden Scale (CGB). Secondary outcome measures were the Family Adaptability and Cohesion Evaluation Scale (FACES) and Quality of Life after Brain Injury Questionnaire (QOLIBRI). Group differences were analysed with linear mixed-model analysis for repeated measurements. RESULTS: No significant between-group differences were found. The intervention group significantly improved on the MCS, the CGB and FACES in the treatment period, whereas the controls did not. The mean (SD) MCS change in the treatment period was 2.4 (1.1) points P = 0.028 in the intervention group. Mean (SE) MCS scores were 47.9 (1.26) and 47.3 (1.27) in the intervention and control group at last follow-up. CONCLUSIONS: Receiving an eight-session family intervention, in addition to specialised rehabilitation for the patients, was not superior to rehabilitation at a specialised traumatic brain injury outpatient clinic.

Needs for Community-Based Rehabilitation Services and Support 12 Months After Moderate and Severe Physical Traumatic Injuries: A Brief Report.

ABSTRACT: Patients with physical traumatic injuries frequently require long-term rehabilitation services. To strengthen rehabilitation services in the postacute phase, we need to assess characteristics of this population and their healthcare and rehabilitation needs in the community. This brief report summarizes the frequency of unmet rehabilitation needs in community-based rehabilitation during the first year after moderate and severe trauma. Additionally, the associations between sociodemographic, injury severity factors and unmet needs were examined. Data from a prospective multicenter cohort study of patients with moderate and severe trauma (New Injury Severity Score > 9) of all ages, discharged alive from two regional trauma centers in 2020 were used. Needs were estimated using the Needs and Provision Complexity Scale. Overall, 46% of patients had unmet needs at 12-mo postinjury, particularly related to the provision of rehabilitation services, specialist follow-ups, and social and family support. The probability of unmet needs was associated with age, preinjury comorbidities, and impaired functioning. Our findings support strategies targeting younger patients, those with preinjury comorbidities, and those with higher levels of disability and provide a starting point for the development of standardized rehabilitation needs assessment and guidelines after injury.

Unmet rehabilitation needs in the first 6 months post-injury in a trauma centre population with moderate-to-severe traumatic injuries.

OBJECTIVE: To describe the needs for subacute inpatient rehabilitation and community-based healthcare services, rehabilitation, and social support in patients with moderate-to-severe traumatic injury in the first 6 months post-injury. Further, to explore associations between sociodemographic and clinical characteristics and unmet needs. DESIGN: Multicentre prospective cohort study. SUBJECTS: Of 601 persons (75% males), mean (standard deviation) age 47 (21) years, admitted to trauma centres in 2020 with moderate-to-severe injury, 501 patients responded at the 6-month follow-up and thus were included in the analyses. METHODS: Sociodemographic and injury-related characteristics were recorded at inclusion. Estimation of needs was assessed with the Rehabilitation Complexity Scale Extended-Trauma and the Needs and Provision Complexity Scale on hospital discharge. Provision of services was recorded 6 months post-injury. Multivariable logistic regressions explored associations between baseline variables and unmet inpatient rehabilitation and community-based service needs. RESULTS: In total, 20% exhibited unmet needs for subacute inpatient rehabilitation, compared with 60% for community-based services. Predictors for unmet community-based service needs included residing in less central areas, profound injury severity, severe head injury, and rehabilitation referral before returning home. CONCLUSION: Inadequate provision of healthcare and rehabilitation services, particularly in the municipalities, resulted in substantial unmet needs in the first 6 months following injury.

Associations between protective resources and family functioning after traumatic brain injury: A cross-sectional study using a structural equation modeling approach.

BACKGROUND: A strength-based approach in the rehabilitation after traumatic brain injury (TBI) is recommended for patients and their families. However, further exploration of the complexity of individual and family factors is needed. OBJECTIVE: To explore the associations between individual protective resources in patients and family members and the overall family functioning using a strength-based approach. METHODS: Secondary analysis of data collected at baseline in a randomized controlled trial. Structural equation modeling with two latent constructs and six observed variables was performed. Outcome measures included the Resilience Scale for Adults, the Mental Component Summary (SF-36), the General Self-Efficacy Scale, and the Family Adaptability and Cohesion Evaluation Scale-IV. RESULTS: Hundred and twenty-two participants (60 patients, 62 family members) with a mean age of 43 years were included at a median of 11 months post-injury. The final model demonstrated a strong covariance (coefficient = 0.61) between the latent Protective construct and Family functioning. Model-fit statistics indicated an acceptable fit to the data. CONCLUSION: Higher levels of protective resources (resilience, self-efficacy, and mental HRQL) were positively associated with family functioning. These resources should be further assessed in patients and their families, to identify factors that can be strengthened through TBI rehabilitation intervention.

Community Integration and Associated Factors 10 Years after Moderate-to-Severe Traumatic Brain Injury.

This study evaluated the impact of baseline injury characteristics and one-year functional level on the 10-year community integration outcomes for working-age patients with moderate-to-severe traumatic brain injury (TBI). Patients aged 16-55 and diagnosed with moderate-to-severe TBI within 24 h of injury were eligible for the study. Multivariable hierarchical linear regression was utilized to assess the impact of baseline characteristics and one-year functional measures on the mean Community Integration Questionnaire (CIQ) scores 10 years after injury. Of 133 original study participants, 97 survived 10 years, and 75 were available for this study. The mean total CIQ score changed positively from one to 10 years post-injury, from 18.7 (±5.5) to 19.8 (±4.8) (p = 0.04). The results suggested that age (ß = -0.260, p = 0.013), FIM-Cognitive subscale (ß = 0.608, p = 0.002), and the bodily pain subscale (BP) (ß = 0.277, p = 0.017) of the SF-36 were significantly associated with the mean CIQ scores. In conclusion, this study demonstrated improved community integration from one to 10 years in a sample of working-age patients with moderate-to-severe TBI. The findings also showed that age, cognitive function, and bodily pain were significant predictors of long-term community integration, suggesting post-acute rehabilitation should focus on factors related to long-term risk and protective factors to improve long-term outcomes.

Adherence to Guidelines for Acute Rehabilitation in the Norwegian Trauma Plan.

OBJECTIVE: To evaluate adherence to 3 central operational recommendations for acute rehabilitation in the Norwegian trauma plan. METHODS: A prospective multi-centre study of 538 adults with moderate and severe trauma with New Injury Severity Score > 9. RESULTS: Adherence to the first recommendation, assessment by a physical medicine and rehabilitation physician within 72 h following admission to the intensive care unit (ICU) at the trauma centre, was documented for 18% of patients. Adherence to the second recommendation, early rehabilitation in the intensive care unit, was documented for 72% of those with severe trauma and ≥ 2 days ICU stay. Predictors for early rehabilitation were ICU length of stay and spinal cord injury. Adherence to the third recommendation, direct transfer of patients from acute ward to a specialized rehabilitation unit, was documented in 22% of patients, and occurred more often in those with severe trauma (26%), spinal cord injury (54%) and traumatic brain injury (39%). Being employed, having head or spinal chord injury and longer ICU stay were predictors for direct transfer to a specialized rehabilitation unit. CONCLUSION: Adherence to acute rehabilitation guidelines after trauma is poor. This applies to documented early assessment by a physical medicine and rehabilitation physician, and direct transfer from acute care to rehabilitation after head and extremity injuries. These findings indicate a need for more systematic integration of rehabilitation in the acute treatment phase after trauma.

Rehabilitation Needs, Service Provision, and Costs in the First Year Following Traumatic Injuries: Protocol for a Prospective Cohort Study.

BACKGROUND: Traumatic injuries, defined as physical injuries with sudden onset, are a major public health problem worldwide. There is a paucity of knowledge regarding rehabilitation needs and service provision for patients with moderate and major trauma, even if rehabilitation research on a spectrum of specific injuries is available. OBJECTIVE: This study aims to describe the prevalence of rehabilitation needs, the provided services, and functional outcomes across all age groups, levels of injury severity, and geographical regions in the first year after trauma. Direct and indirect costs of rehabilitation provision will also be assessed. The overarching aim is to better understand where to target future efforts. METHODS: This is a population-based prospective follow-up study. It encompasses patients of all ages with moderate and severe acute traumatic injury (New Injury Severity Score >9) admitted to the regional trauma centers in southeastern and northern Norway over a 1-year period (2020). Sociodemographic and injury data will be collected. Upon hospital discharge, rehabilitation physicians estimate rehabilitation needs. Rehabilitation needs are assessed by the Rehabilitation Complexity Scale Extended-Trauma (RCS E-Trauma; specialized inpatient rehabilitation), Needs and Provision Complexity Scale (NPCS; community-based rehabilitation and health care service delivery), and Family Needs Questionnaire-Pediatric Version (FNQ-P). Patients, family caregivers, or both will complete questionnaires at 6- and 12-month follow-ups, which are supplemented by telephone interviews. Data on functioning and disability, mental health, health-related quality of life measured by the EuroQol Questionnaire (EQ-5D), and needs and provision of rehabilitation and health care services are collected by validated outcome measures. Unmet needs are represented by the discrepancies between the estimates of the RCS E-Trauma and NPCS at the time of a patient's discharge and the rehabilitation services the patient has actually received. Formal service provision (including admission to inpatient- or outpatient-based rehabilitation), informal care, and associated costs will be collected. RESULTS: The project was funded in December 2018 and approved by the Regional Committee for Medical and Health Research Ethics in October 2019. Inclusion of patients began at Oslo University Hospital on January 1, 2020, and at the University Hospital of North Norway on February 1, 2020. As of February 2021, we have enrolled 612 patients, and for 286 patients the 6-month follow-up has been completed. Papers will be drafted for publication throughout 2021 and 2022. CONCLUSIONS: This study will improve our understanding of existing service provision, the gaps between needs and services, and the associated costs for treating patients with moderate and major trauma. This may guide the improvement of rehabilitation and health care resource planning and allocation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25980.

Mental Health and Family Functioning in Patients and Their Family Members after Traumatic Brain Injury: A Cross-Sectional Study.

Traumatic brain injury (TBI) affects the family as a whole. This study aimed to describe and compare mental health and family functioning in TBI patients and their family members, and to identify individual and family-related factors that were associated with mental health. It was conducted at an urban, specialized, TBI outpatient clinic and included 61 patients with mild to severe TBI and 63 family members. Baseline demographics and injury-related data were collected, and the participants answered standardized, self-reported questionnaires 6-18 months post-injury that assessed mental health; general health; family functioning, communication, and satisfaction; depression and anxiety; self-efficacy; resilience; and condition-specific quality of life. The patients reported significantly worse mental health, depression, resilience, self-efficacy, and general health compared with the family members. Patients and family members had similar perceptions, showing balanced family functioning, high family communication levels, and moderate family satisfaction. Factors significantly associated with mental health in patients and family members were depression, anxiety, and resilience, explaining 56% of the variance (p < 0.001). Family-related factors were not associated with mental health. The disease burden was mainly on the patients; however, the family members also reported emotional distress. Family-targeted interventions across the TBI continuum should be considered.

Long-term follow-up of use of therapy services for patients with moderate-to-severe traumatic brain injury.

OBJECTIVES: To examine the probabilities and baseline predictors of the use of physical therapy, occupational therapy and speech therapy over a period of 10 years after traumatic brain injury. DESIGN: Longitudinal prospective follow-up at 1, 2, 5 and 10 years after traumatic brain injury. PARTICIPANTS: A total of 97 patients with moderate-to-severe traumatic brain injury recruited from Oslo University Hospital, Norway, during acute hospital admission in 2005-2007. METHODS: Socio-demographics and injury characteristics were recorded at baseline. Use of physical therapy, occupational therapy and speech therapy were recorded at follow-ups. Hierarchical linear modelling was applied to examine service use probabilities across the 4 time-points. RESULTS: Service use decreased substantially over time, with physical therapy being the main service utilized at the 10-year follow-up (physical therapy 16%, occupational therapy 1%, speech therapy 3%). Use of services was related to severity of injury (CT head severity scores and post-traumatic amnesia), female sex, and pre-injury employment. In addition, in this sample, time since injury was associated with use of occupational therapy and speech therapy. CONCLUSION: This study presents a novel model for the long-term probability of use of physical therapy, occupational therapy and speech therapy following traumatic brain injury. The use of services was much lower than the expected problem profile of severe traumatic brain injuries, suggesting an insufficient long-term provision of traditional traumatic brain injury rehabilitation services.