Clinical trial NCT05793736: Prevention of Long Covid Syndrome
Official title: A Feasibility Study of an HVR Protocol Biofeedback Training to Manage Long Covid Syndrome Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Biofeedback, Psychology
Quality of Life
Depressive Symptoms
Fatigue
Anxiety
Pain
Cognitive Symptom
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a controlled clinical feasibility trial with three evaluation times (T0 pre-treatment; T1 post treatment five weeks after T0; T2 nine weeks after T1) aimed at verifying the feasibility and tolerability of an intervention performed with biofeedback training (already extensively tested on other clinical populations and free of side effects) and aimed to obtain a preliminary measure of its effectiveness on patients with Long Covid syndrome
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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

Detailed description: 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).

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 (evidence were shown as regards stress menagement).

The greatest benefits from using biofeedback are: improvement of sleep quality, improvement of self- efficacy, improvement of pain threshold, and improvement of emotional adjustment. In particular, a study conducted with HRV biofeedback, in which the sample learned resonance frequency breathing, showed dicreases in depression and pain and improved the person's system functioning.

Study objectives

The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with Long Covid syndrome, and also to produce a preliminary measurement of the possible improvement induced by the technique in relation to:cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms. This measure will be useful to estimate the expected improvement in future case-control studies. Study design

This is a controlled clinical trial between usual care and biofeedback training plus usual care.

Eligibility criteria: Inclusion Criteria:

* People who have contracted Covid-19 and have symptoms attributable to Long syndrome

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change in Checklist on tolerability, possible side effects after the biofeedback session
timeFrame: At the end of each biofeedback session
measure: Intervention satisfaction questionnaire
timeFrame: T1 (5weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
measure: Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score
timeFrame: T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: P.O. San Giovanni di Dio, AOU Cagliari
Study officials:
References: