Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial
- Conditions
- Long COVID
- Interventions
- Behavioral: Multi-systemic Rehabilitation
- Registration Number
- NCT06379737
- Lead Sponsor
- Padua University General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Home-based rehabilitation Multi-systemic Rehabilitation Perform home-based rehabilitation Health resort medicine rehabilitation Multi-systemic Rehabilitation Perform Health resort medicine rehabilitation
- Primary Outcome Measures
Name Time Method Fatigue Assessment Scale immediately before and after intervention and 3 and 6 months follow-ups a self-report questionnaire designed to assess the severity and impact of fatigue. It consists of 10 items, describing different aspects of fatigue.
Barthel Dyspnea Scale immediately before and after intervention and 3 and 6 months follow-ups 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
Hand grip strength immediately before and after intervention and 3 and 6 months follow-ups the strength of the dominant hand was assessed using a digital handheld dynamometer
Numerical Rating Scale (NRS) immediately before and after intervention and 3 and 6 months follow-ups 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
12-Item Short Form Health Survey (SF-12) immediately before and after intervention and 3 and 6 months follow-ups 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
Beck's Depression Inventory (BDI immediately before and after intervention and 3 and 6 months follow-ups the BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Beck Anxiety Inventory (BAI) immediately before and after intervention and 3 and 6 months follow-ups 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
- Secondary Outcome Measures
Name Time Method Patients satisfaction immediately after intervention Specifically designed questionnaire (Likert scale)
Trial Locations
- Locations (1)
Universityof Padua
🇮🇹Padova, Italy