A Feasibility Study of an HVR Protocol Biofeedback Training to Manage Long Covid Syndrome Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score
研究概览
简要总结
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome.
The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with long covid, and also to verify improvement induced by the technique in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms
详细描述
Long COVID is known by different names, and include a wide range of persistent symptoms that develop after SARS-CoV-2 infection and last for usually more than 12 weeks to months and up to 2 years, so far. The most common symptoms categorizable as neurological are fatigue, brain fog, and headache, among respiratory symptoms chest pain and shortness of breath, other less easily classifiable symptoms are heart palpitations and muscle pain. These symptoms are often debilitating enough to leave patients unable to work.
According to the WHO (2023), an estimated 17 million people were thought to be living with the long-term effects of COVID-19. Still now in less active pandemic phases, the risk of developing long COVID symptoms, at 10-20% of those infected, remains just as strong.
Trying to find a solution to manage symptoms through evidence-based practices is considered a current necessity to help health patients and professionals.
Biofeedback allows to learn self-regulation of some physiological processes through feedback of recorded parameters and the goal is improving health and its performances.
Biofeedback measures muscle activity, skin temperature, electrodermal activity (sudoriparous glands activity), respiration, heart rate, blood pressure, electrical brain activity and bloodstream, it also gives a quick feedback of those personal measurements to the patient, in this way biofeedback teaches people to have a more active role in maintaining a good personal, mental and physical health (quickly and thoroughly it give person feedback of activity and biofeedback teaches people to take a more active role in maintaining personal health and mental health and physical health).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People who have contracted Covid-19 and have symptoms attributable to Long syndrome
排除标准
- •patients with cognitive difficulties and/or diagnosis of mental retardation
- •patients with severe comorbidities with the exception of anxious/depression symptoms arising in conjunction with the viral infection or long covid syndrome.
研究组 & 干预措施
biofeedback + treatment as usual
The selected sample (n 10) will undergo 10 total Biofeedback Training sessions, twice a week. Each session will last 45 minutes. The total duration of the treatment will be 5 weeks, plus standard therapies (treatment as usual)
干预措施: Biofeedback training (Device)
treatment as usual
The control sample (n 10) will be treated only with standard therapies (treatment as usual) without the use of biofeedback training
干预措施: Treatment as usual (Drug)
结局指标
主要结局
Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
The Brief Fatigue Inventory (BFI) is a brief screening tool designed to assess the severity and impact of fatigue on daily functioning.
Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Allows you to have a visual representation of the amplitude of the pain perceived by the person ache
Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluate verbal short-term memory and working memory
Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests
Intervention satisfaction questionnaire
时间窗: T1 (5weeks)
Intervention satisfaction questionnaire
Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
short self-administered tool used for screening, diagnosis, monitoring and measuring the severity of depression. It's composed of 9 items that correspond to the symptoms of major depression according to DSM-IV. The score has a range between 0 and 27. Scores between 0 and 9 indicate the presence of a sub-threshold depression. The score of 10 is indicated as the point at which the sensitivity and specificity of the instrument are recognized as optimal for highlighting depressions of clinical relevance
Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
SAS is a 20-item self-report assessment device built to measure anxiety levels, based on scoring in 4 groups of manifestations: cognitive, autonomic, motor and central nervous system symptoms.
Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
The Short Form Health Survey (SF-12), brief version of SF-36 questionnaire, made up of twelve questions, includes the following dimensions: physical activity, disturbance in physical health, physical condition, self-assessment of health status, vitality, social activity and mental health. Higher SF-12 scores recorded a greeting and QoL performance.
Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention
Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates the indicators of selective attention
Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility
Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score
时间窗: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Evaluates long-term memory, semantic memory, specifies in which phase of the mnemonic process the deficit is
Change in Checklist on tolerability, possible side effects after the biofeedback session
时间窗: At the end of each biofeedback session
Checklist on tolerability, possible side effects after the biofeedback session
次要结局
未报告次要终点
研究者
Giulia Cossu
Principal Investigator
University of Cagliari