Combined Pulmonary Rehabilitation and PMR for Long-Term COVID-19 Symptoms: A RCT
NCT Number: NCT06492577
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long Covid19|Pulmonary Rehabilitation|Progressive Muscle Relaxation
Interventions: OTHER: Pulmonary rehabilitation protocol|OTHER: Progressive muscle relaxation protocol
Sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-11-30
Locations: Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes, Timisoara, Timis, 300301, Romania

Summary:
Our study aimed to evaluate the effectiveness of a 21-day program combining pulmonary rehabilitation (PR) with progressive muscle relaxation (PMR) in patients experiencing long-term symptoms of COVID-19. Participants with persistent symptoms will be randomly assigned to either a PR group or a PR combined with PMR group. The PR program includes aerobic exercises, strength training, and breathing exercises, while the PMR sessions involve systematic muscle tensing and relaxation techniques. We will measure outcomes such as lung function, exercise capacity, anxiety, depression, and sleep quality using validated questionnaires and clinical tests.

Primary Outcome Measures: Lung function, Spirometry is a pulmonary function test used to assess lung function by measuring the volume and speed of air that can be inhaled and exhaled. During the procedure, the patient sits upright, uses a nose clip, and takes a deep breath in. They then exhale as forcefully and quickly as possible into a spirometer through a disposable mouthpiece. This process measures the maximum volume of air expelled (Forced Vital Capacity, FVC) and the volume expelled in the first second (Forced Expiratory Volume in One Second, FEV1). The test is repeated at least three times to ensure accuracy, and the best effort is recorded., 20 minutes|Exercise capacity, The exercise capacity evaluation will be conducted using the 6-minute walk test (6MWT). During the test, the patient is instructed to walk back and forth along a flat, straight 30-meter course for six minutes, aiming to cover as much distance as possible. The total distance walked in six minutes is measured in meters. Rest periods are allowed if necessary, but the clock continues to run., 20 minutes|Anxiety, Anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7). This self-administered questionnaire consists of seven items, each scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety., At inclusion and at the end of the study|Depression, Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). This self-administered questionnaire includes nine items, each scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Higher scores indicate more severe depression., 20 minutes|Sleep Quality, Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). This self-rated questionnaire assesses sleep quality and disturbances over a one-month period. It consists of 19 items, generating seven component scores that are summed to produce a global score ranging from 0 to 21, with higher scores indicating worse sleep quality., 20 minutes|Psychological Well-being, Psychological well-being will be assessed using the General Health Questionnaire-12 (GHQ-12). This self-administered questionnaire includes 12 items, each scored on a 4-point scale (less than usual, no more than usual, rather more than usual, or much more than usual), with a total score ranging from 0 to 36. Higher scores indicate greater levels of psychological distress., 20 minutes