Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial

NCT ID: NCT06379737

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-20

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.

Conditions

Long COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home-based rehabilitation

Perform home-based rehabilitation

Group Type: ACTIVE_COMPARATOR

Multi-systemic Rehabilitation

Intervention Type: BEHAVIORAL

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

Health resort medicine rehabilitation

Perform Health resort medicine rehabilitation

Group Type: EXPERIMENTAL

Multi-systemic Rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Padua University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stefano Masiero

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universityof Padua

Padua, , Italy

Countries

Italy

Other Identifiers

MASI_CARIVARI21_01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

359n/AO/23

Identifier Type: -

Identifier Source: org_study_id