An interventional study of Multi-systemic Rehabilitation in Long COVID, sponsored by Padua University General Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Padua University General Hospital · Not applicable, Interventional, and Treatment
Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.
Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.
Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction.
At the outpatient clinics of the Neurorehabilitation Unit of the University Hospital of Padua, 103 patients were initially assessed. Out of these patients, 72 subjects of both genders with medium-to-long-term outcomes following previous infection with the SARS-CoV-2 virus were recruited for this study. Eight patients were excluded from the study due to initial assessments revealing conditions falling under exclusion criteria (1 patient lacked a prior diagnosis with a COVID-19 infection swab, 2 had concurrent tumor pathologies, 3 exhibited systemic inflammation, and 2 had skin infections), and 23 patients chose to undergo a rehabilitation program at a rehabilitative gym instead. Participants were randomly assigned to one of two rehabilitation treatment groups: the group treated at a health resort facility (Group A, n=36) and the group performing the exercise program at home (Group B, n=36). However, 6 patients did not complete follow-up assessments at different time points, resulting in the final evaluation of data collected from 66 patients, with 33 allocated to Group A and 33 to Group B (Fig. 1).
The patient enrollment was conducted between January 2023 and April 2023. Patients in group A underwent a 5-week rehabilitation cycle with two weekly sessions, totaling 10 sessions, in a health resort setting. The patients underwent treatments at two health resort facilities located in the Euganean Basin, Veneto, Italy, equipped with pools of the same depth, size, and water type. Patients in group B underwent a 5-week rehabilitation cycle at home with two weekly sessions, totaling 10 sessions.
At the beginning (T0) and at the end (T1) of the treatment, and during two subsequent follow-up times at 3 months (T2) and 6 months (T3), after the end of the treatment, patients in both groups were evaluated.
536 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 187 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 369 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →This is the only study on the registry with Padua University General Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria for the study included the following requirements: age between 18 and 75 years; a previous COVID-19 infection occurring between 6 and 18 months before our initial assessment; negative results in tests for the nucleic acid of the SARS-CoV-2 virus conducted on respiratory samples, such as oropharyngeal swabs; body temperature ≤ 37°C; presence of reduced cardio-respiratory capacity and/or motor deficits caused by the SARS-CoV-2 virus infection; manifestation of possible cognitive symptoms that could not be attributed to other conditions; no participation in cycles of thermal mineral-rich therapy in the six months preceding the study.
Exclusion criteria from the study included: inability to understand and sign the informed consent form; absence of a previous positive detection of nucleic acid of the SARS-CoV-2 virus in tests on respiratory samples; current positivity for the nucleic acid of the SARS-CoV-2 virus in respiratory samples; epilepsy, severe psychiatric disorders, neoplasms, or pregnancy. Moreover, commonly recognized contraindications for health resort treatments, such as skin infections or open wounds, systemic inflammation, heart, liver, respiratory, or kidney failure, and urinary or fecal incontinence, were considered additional exclusion criteria.
Perform home-based rehabilitation
Behavioral: Multi-systemic Rehabilitation
Perform Health resort medicine rehabilitation
Behavioral: Multi-systemic Rehabilitation
Patients in group A underwent a 5-week rehabilitation cycle with two weekly sessions, totaling 10 sessions, in a health resort setting. The patients underwent treatments at two health resort facilities located in the Euganean Basin, Veneto, Italy, equipped with pools of the same depth, size, and water type. Each session was structured into four components: 1. thermal mineral-rich aerosol therapy (10 minutes); 2. dryland motor, respiratory, and proprioceptive rehabilitation in the gym (30 minutes); 3. mineral-rich aquatic aerobic, strengthening, and balance exercises (30 minutes); 4. cognitive enhancement interventions (30 minutes). Inhalation treatments and aquatic exercises utilized thermal mineral-rich water, specifically salsobromoiodic water, naturally springing at approximately 80°C and used in pools at a temperature of around 36°C. The chemical-physical properties of the thermal mineral-rich water employed are reported in Table I. Patients in group B underwent a 5-week rehabilit
Numerical Rating Scale (NRS)
a commonly used pain assessment tool that involves asking patients to rate their pain verbally or visually on a scale from 0 to 10, with 0 indicating no pain and 10 representing the worst possible pain
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
Hand grip strength
the strength of the dominant hand was assessed using a digital handheld dynamometer
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
Barthel Dyspnea Scale
The Barthel Dyspnea Scale is a validated tool used to measure the severity of dyspnea. It evaluates various activities and tasks that may provoke dyspnea, allowing to assess and monitor the impact of dyspnea on a patient's daily life
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
Fatigue Assessment Scale
a self-report questionnaire designed to assess the severity and impact of fatigue. It consists of 10 items, describing different aspects of fatigue.
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
Beck's Depression Inventory (BDI
the BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
Beck Anxiety Inventory (BAI)
the BAI is a self-report questionnaire designed to assess the severity of anxiety symptoms and consists of 21 items that measure various aspects of anxiety
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
12-Item Short Form Health Survey (SF-12)
The SF-12 is employed for assessing health-related quality of life (HRQoL). It is a shortened version of the SF-36, consisting of 12 items that measure eight health domains, including physical functioning, limitations due to physical health problems, bodily pain, general health perception, vitality, social functioning, limitations due to emotional problems, and mental health
Time frame: immediately before and after intervention and 3 and 6 months follow-ups
Patients satisfaction
Specifically designed questionnaire (Likert scale)
Time frame: immediately after intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Dec 2023, 11 months.
Of 198 non-industry interventional studies with no phase under Post-Acute COVID-19 Syndrome, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 11 months is below that.
Counting every sponsor, half of 207 studies reached it within 19 months; a quarter within 10 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Post-Acute COVID-19 Syndrome →