Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.
Center for Habilitation and Rehabilitation Models and Services (CHARM), Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.
BMC Neurol. 2023 May 3;23(1):179. doi: 10.1186/s12883-023-03221-7.
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.
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.
Randomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1.
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.
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.
Clinical Trials.gov, NCT05086419. Registered on September 5th, 2021.
轻度创伤性脑损伤（mTBI）后，约 34%至 46%的患者会持续出现脑震荡后症状（PPCS）。许多患者还会出现运动不耐受。亚症状阈有氧运动（SSTAE，即在不增加症状的强度水平下进行的运动）被提议作为一种治疗方法，以减轻症状负担并增加损伤后的运动耐量。目前尚不清楚在 mTBI 后更慢性阶段是否也适用。
本研究的主要目的是评估 SSTAE 是否除了普通康复外，还能在与对照组（仅接受普通康复）相比，在减轻症状负担、使运动耐量正常化、增加身体活动、改善健康相关生活质量和减少患者特定的活动限制方面带来临床意义上的改善。
随机、对照、单盲平行组研究，共进行三次测量；T0 为基线时，T1 为干预后，T2 为 T1 后 6 个月。
将招募年龄在 18 至 60 岁之间、有运动不耐受和持续性 PPCS（>3 个月）的患者入组并随机分为两组。所有患者都将在 TBI 门诊接受随访。干预组除了接受 12 周的 SSTAE 外，还将接受运动日记和每 3 周进行一次复测，以确定最佳剂量和进展。Rivermead 脑震荡后症状问卷将作为主要结局测量指标。次要结局测量指标将是一项运动耐量测试——布法罗脑震荡跑步机测试。其他结局测量指标包括患者特定的功能量表，用于测量患者特定的活动限制，以及针对特定疾病的健康相关生活质量、焦虑和抑郁、特定症状（如头晕、头痛和疲劳）和身体活动的诊断特异性结局测量指标。
本研究将增加关于 SSTAE 效果的知识，以及是否应该将其纳入 mTBI 后成人持续性 PPCS 的康复治疗中。嵌套可行性试验表明，SSTAE 干预是安全的，并且研究程序和整体干预的实施是可行的。然而，在进行 RCT 之前，对研究方案进行了一些小的修改。
ClinicalTrials.gov，NCT05086419。于 2021 年 9 月 5 日注册。
