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

NCT06379737 | Completed

• 2 other identifiers: 359n/AO/23MASI_CARIVARI21_01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Keywords

rehabilitation; recovery; COVID-19; health resort medicine; balneotherapy

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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.

  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

  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

  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

  immediately before and after intervention and 3 and 6 months follow-ups

Secondary Outcomes (1)

• Patients satisfaction

  immediately after intervention

Study Arms (2)

Home-based rehabilitation

ACTIVE COMPARATOR

Perform home-based rehabilitation

Behavioral: Multi-systemic Rehabilitation

Health resort medicine rehabilitation

EXPERIMENTAL

Perform Health resort medicine rehabilitation

Behavioral: Multi-systemic Rehabilitation

Interventions

Multi-systemic Rehabilitation 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; Home-based rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Padua University General Hospital: lead

Study Sites (1)

Universityof Padua

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: January 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)