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Prevention of Long Covid Syndrome

Primary Purpose

Post-Acute COVID-19 Syndrome, Biofeedback, Psychology, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biofeedback training
Treatment as usual
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Post-Acute COVID-19 Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • P.O. San Giovanni di Dio, AOU CagliariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

biofeedback + treatment as usual

treatment as usual

Arm Description

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)

The control sample (n 10) will be treated only with standard therapies (treatment as usual) without the use of biofeedback training

Outcomes

Primary Outcome Measures

Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score
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 Brief Fatigue Inventory (BFI) score
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 Short Form Health Survey (SF-12) score
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 Matrix test (Spinnler H, Tognoni G., 1987) score
Evaluates the indicators of selective attention
Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score
Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention
Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score
Evaluate verbal short-term memory and working memory
Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score
Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility
Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score
It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests
Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score
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
Checklist on tolerability, possible side effects after the biofeedback session
Intervention satisfaction questionnaire
Intervention satisfaction questionnaire
Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score
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 Self-Rating Anxiety Scale (SAS) score
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.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2023
Last Updated
March 28, 2023
Sponsor
University of Cagliari
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1. Study Identification

Unique Protocol Identification Number
NCT05793736
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
February 2, 2024 (Anticipated)
Study Completion Date
June 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome, Biofeedback, Psychology, Quality of Life, Depressive Symptoms, Fatigue, Anxiety, Pain, Cognitive Symptom

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 T0) 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
Masking
Investigator
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
biofeedback + treatment as usual
Arm Type
Experimental
Arm Description
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)
Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Description
The control sample (n 10) will be treated only with standard therapies (treatment as usual) without the use of biofeedback training
Intervention Type
Device
Intervention Name(s)
Biofeedback training
Intervention Description
The intervention lasts 5 weeks, twice a week, each session lasts 45 minutes in which HRV (Heart Rate Variability) is detected, through plethysmographic sensors placed on the finger or earlobe during assigned tasks. During tasks that involve progressively more complex phases, they allow the person to receive immediate feedback on the video screen.
Intervention Type
Drug
Intervention Name(s)
Treatment as usual
Intervention Description
The sample will be treated only with standard therapies (treatment as usual) without the use of biofeedback training
Primary Outcome Measure Information:
Title
Change from Baseline to 5 weeks and to 9 weeks in Patient Health Questionnaire-9 (PHQ-9) score
Description
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
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Brief Fatigue Inventory (BFI) score
Description
The Brief Fatigue Inventory (BFI) is a brief screening tool designed to assess the severity and impact of fatigue on daily functioning.
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Short Form Health Survey (SF-12) score
Description
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.
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Matrix test (Spinnler H, Tognoni G., 1987) score
Description
Evaluates the indicators of selective attention
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Trail Making Test (Giovagnoli et al.,1996) score
Description
Evaluates cognitive functions such as cognitive flexibility and inhibitory control and attention
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Digit Span (Orsini et al., 1987; Mondini et al., 2003) score
Description
Evaluate verbal short-term memory and working memory
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Stroop Test (Caffarra et al.; 2002) score
Description
Evaluates selective attention, the processes of inhibition of irrelevant information and cognitive flexibility
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Frontal Assessment Battery - FAB (Dubois et al.; 2000) score
Description
It is a functionality screening battery global executive performance by means of a series of cognitive and behavioral tests
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Rey's Word Test (Caltagirone et al. 1995) score
Description
Evaluates long-term memory, semantic memory, specifies in which phase of the mnemonic process the deficit is
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change in Checklist on tolerability, possible side effects after the biofeedback session
Description
Checklist on tolerability, possible side effects after the biofeedback session
Time Frame
At the end of each biofeedback session
Title
Intervention satisfaction questionnaire
Description
Intervention satisfaction questionnaire
Time Frame
T1 (5weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Visual Analog Scale VAS (Scott Huskisson, 1976) score
Description
Allows you to have a visual representation of the amplitude of the pain perceived by the person ache
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)
Title
Change from Baseline to 5 weeks and to 9 weeks in Self-Rating Anxiety Scale (SAS) score
Description
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.
Time Frame
T0 (0 weeks); T1 (5weeks); T2 (9 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro Carta, Professor
Phone
3924944509
Ext
0039
Email
maurogcarta@gmail.com
Facility Information:
Facility Name
P.O. San Giovanni di Dio, AOU Cagliari
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Carta, MD
Phone
070 6093498
Ext
0039
Email
maurogcarta@gmail.com
First Name & Middle Initial & Last Name & Degree
Federica Sancassiani
First Name & Middle Initial & Last Name & Degree
Mauro Carta
First Name & Middle Initial & Last Name & Degree
Alessandra Perra

12. IPD Sharing Statement

Learn more about this trial

Prevention of Long Covid Syndrome

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