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临床试验/NCT05785000
NCT05785000招募中不适用

Rehabilitation of Adult Patients With Post Concussion Syndrome

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Change in Buffalo Concussion Bike Test from baseline measurement to week 12

研究概览

简要总结

This project evaluates and quantifies the effects of an individually tailored exercise program applied to patients with long-lasting symptoms after concussion, minor traumatic brain injury, so-called Post-Concussion Syndrome (PCS). The project investigates the phenomenon Post Concussion Syndrome in four dimensions with a focus on both patient perspectives of PCS, an interventional physical program, a neurobiological basis for PCS through Magnetic Resonance Imaging (MRI) and finally through a 360-degree evaluation of the entire project involving patients and scientists in a reflective process.

详细描述

The project has four parts

Aims and hypotheses:

  1. The aim is to describe and nuance the subjective patient perceived aspects of living with PCS including the individual experiences of symptom provocation or relieve after the initial trauma. Part one is concept developing and involves qualitative in-depth interviews of patient experiences of obstacles for living a normal life with special emphasis of intolerance to activity and exercise.
  2. The aim is to assess the effects of adding a 12 week individually tailored pulse-controlled aerobe exercise program to usual care. The hypothesis is that it is possible to increase the physical capacity measured by the number of minutes of pulse-training without symptom provocation. By increasing the number of minutes the threshold value of symptom provocation will be moved upwards for a training group (TG) of patients compared to a control group (CG) who carry on in their usual activities and treatments here defined as usual care.
  3. The aim is to measure quantitative components of the neurobiological aspects of PCS by magnetic resonance imaging (MRI). The hypothesis is that patients with PCS have more leakiness of the blood-brain barrier (BBB) compared to healthy controls. In addition, PCS patients have disturbance of brain metabolism, abnormal microstructural tissue organization and abnormal brain activity. Furthermore, that intervention will normalize these MRI metrics in a training group (TG) compared to a control group (CG).
  4. The aim is to obtain qualitative components of having patients and scientists evaluating the project. The evaluation will comprise participants involved, i.e. both patients in the 2 arms and researchers and the goal of this 360-degree evaluation is to describe perceived experiences of strength, weakness, possibility and threat (SWOT) of the intervention and ultimately prevent development of PSC after a minor traumatic brain injury.

Methods - the four parts:

  1. Qualitative interviews of PCS participants focusing on individual perception of own situation, detailed symptom description, hindrance of living a normal life.
  2. All PSC patients continue daily living and own developed coping strategies. The intervention is an add-on. We use Short Message Service (SMS) tracking every week obtaining details of wellbeing related to living with concussion. The intervention consists of bi-weekly one hour exercise guided by physiotherapist for 12 weeks. Clinical status is performed four times- before and after 12 weeks and with two interim assessments. We use the validated Buffalo Concussion Bike Test (BCBT ). Blood pressure, pulse rate, pulse oxymetri and exercise level are registered and we use Visual Analog Scale (VAS) and BORG Ratings of Perceived Exertion (BORG RPE) scales. In addition we use the Rivermead Post Concussion Questionnaire (RPCQ ).
  3. Blood brain barrier (BBB) permeability is measured by Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) using a conventional MRI contrast agent. Both the leakiness (Ki) of the BBB, brain blood volume, capillary mean transit and distribution of transit times are estimated together with brain tissue perfusion (CBF). Other functional MRI measures are obtained such as the brain microstructural organization, measured by diffusion sensitive MRI and brain activity by Blood-oxygenation level dependent Imaging and brain lactate production as a measure of brain metabolism.
  4. The 360-degree evaluation of the entire project is a joint, narrative process where patients, researcher and students involved sit together using a process evaluating principle. A data triangulation and a reflection of pros and cons of the project will guide the process. The evaluation is guided by an expert in process evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The assessors of outcomes at the end of the project are different to the assessors of clinical test at entry to the project

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Post concussion syndrome (PCS) diagnose according to WHO ICD-10 classification and documented by written statement from physician veritying a mild traumatic brain injury
  • Longer lasting symptoms for at least 4 weeks after initial trauma
  • If allocated to add-on exercise protocol participant must feel able to prioritize the intervention structure
  • Communication language must be Danish

排除标准

  • Other diseases blurring the diagnose PCS
  • Other serious brain diseases
  • Severe cardiovascular diseases precluding physical activity according to protocol

结局指标

主要结局

Change in Buffalo Concussion Bike Test from baseline measurement to week 12

时间窗: Change in Buffalo Concussion Bike Test at week 12

Buffalo Concussion Bike Test is an individualized bike test designed to measure the number of minutes that the patient can cycle without symptom aggrevation. The test is stopped when symptoms worsen judged by VAS, BORG RPE and pulse rate. The result is measured in minutes

次要结局

  • Change in Buffalo Concussion Bike Test from baseline measurement to week 4(Change in Buffalo Concussion Bike Test at week 4)
  • Evaluation of the project(After completion of the 12 week intervention)
  • Case-control comparison; Brain lactate(Comparison measurements at baseline)
  • Changes in Rivermead Post Concussion Questionaire from baseline to week 12(Change in point score at week 12)
  • Changes in Fatique Scale Questionaire from baseline to week 12(Change in point score at week 12)
  • Description of patient perspectives of living with PCS(Assessed at week 12)
  • Change of brain diffusion from baseline to week 12(Change of brain diffusion at week 12)
  • Case- control comparison; Blood brain barrier permeability(Comparison measurements at baseline)
  • Change in Buffalo Concussion Bike Test from baseline to week 8(Change in Buffalo Concussion Bike Test at week 8)
  • Change in Sms tracking domain one: "Physical Ability" of self reported well being in relation to commotio(Change in perceived physical ability at week 12)
  • Change in Sms tracking domain two: "Overall physical symptoms" of self reported well being in relation to commotio(Change in perceived overall physical symptoms at week 12)
  • Change in Sms tracking domain three: "Using the brain" of self reported well being in relation to commotio(Change in perception of "using the brain" at week 12)
  • Changes in Dynamic Gait Index Questionaire from baseline to week 12(Change in dynamic gait at week 12)
  • Change in blood brain barrier permeability from baseline to week 12(Change in blood brain barrier permeability at week 12)
  • Change of brain oxygen consumption from baseline to week 12(Change of brain oxygen consumption at week 12)
  • Change in Sms tracking domain four: "Work ability" of self reported well being in relation to commotio(Change in perception of work ability)
  • Change in Sms tracking domain five: "Quality of daily living" of self reported well being in relation to commotio(Change in perception of quality of daily life)
  • Change of brain lactate from baseline to week 12(Change of brain lactate at week 12)
  • Case-control comparison; Brain diffusion coefficient(Comparison measurements at baseline)
  • Case-control comparison; Brain oxygen consumption(Comparison measurements at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henrik Bo Wiberg Larsson

Consultant, professor

Rigshospitalet, Denmark

研究点 (2)

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