Clinical trial NCT06492577: Combined Pulmonary Rehabilitation and PMR for Long-Term COVID-19 Symptoms: A RCT
Official title: Effectiveness of Combined Pulmonary Rehabilitation and Progressive Muscle Relaxation on Long-term COVID-19 Symptoms: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Covid19
Pulmonary Rehabilitation
Progressive Muscle Relaxation
Keywords: Long-COVID-19
Progressive Muscle Relaxation
Pulmonary Rehabilitation
Exercise Capacity
Anxiety Reduction
Lead sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Sponsor class: OTHER_GOV
First posted: 2024-07-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study aims to evaluate the effectiveness of a 21-day combined pulmonary rehabilitation (PR) and progressive muscle relaxation (PMR) program on improving physical and psychological outcomes in patients with long-term COVID-19 symptoms.

This is a parallel, randomized controlled trial (RCT) with two intervention groups: a pulmonary rehabilitation (PR) group and a PR combined with progressive muscle relaxation (PR + PMR) group.

The study will enroll adults aged 18-75 with persistent moderate to severe long-term COVID-19 symptoms, specifically dyspnea and fatigue, lasting at least three months post-infection. Inclusion criteria include confirmed COVID-19 diagnosis via PCR or antibody tests, stable medical condition, and mental readiness to participate. Exclusion criteria include severe comorbid conditions, recent major surgery, severe cognitive or psychiatric disorders, active respiratory infections, severe mobility impairments, and high alcohol or substance abuse.

Participants in the PR group will undergo a 21-day pulmonary rehabilitation program designed to improve lung function, exercise capacity, and overall physical health, following American Thoracic Society (ATS) guidelines. The program includes aerobic exercises performed five days per week at moderate intensity (4-6 on the Borg RPE scale) for 30-45 minutes per session, including warm-up and cool-down periods. Strength training is conducted three days per week on non-consecutive days, starting at 50% of the one-repetition maximum (1RM) and progressively increasing to 70% as tolerated, with each session lasting 20-30 minutes and including 2-3 sets of 8-12 repetitions for major muscle groups. Daily breathing exercises focusing on controlled techniques such as diaphragmatic and pursed-lip breathing for 10-15 minutes per session.

In addition to the PR program, participants in the PR + PMR group will perform daily PMR sessions designed to reduce anxiety and improve sleep quality. Each PMR session will last 20 minutes, involving systematic muscle tensing and relaxation starting from the feet and progressing to the head, combined with slow, deep breathing.

The primary outcomes include lung function, exercise capacity, anxiety, depression, sleep quality, and psychological well-being.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of COVID-19 through documented positive PCR or antibody tests.
* Persistent long-COVID-19 symptoms, specifically moderate or severe dyspnea and fatigue, lasting for at least three months post-infection.
* Adults aged between 18 and 75 years.
* Stable medical condition with no recent exacerbations or hospital admissions for other conditions in the past three months.

Exclusion Criteria:

* Severe comorbid conditions such as moderate to severe heart disease, severe ischemic or hemorrhagic stroke, neurodegenerative diseases, or severe acute illnesses.
* Major surgery or hospitalization for severe conditions within the past six months.
* Severe cognitive or psychiatric disorders, determined through comprehensive cognitive and psychiatric evaluations.
* Active respiratory infections or immunocompromised status.
* Severe mobility impairments or chronic pain that could limit participation in rehabilitation exercises.
* High alcohol intake or substance abuse.

Primary outcomes:
measure: Lung function
timeFrame: 20 minutes
measure: Exercise capacity
timeFrame: 20 minutes
measure: Anxiety
timeFrame: At inclusion and at the end of the study
measure: Depression
timeFrame: 20 minutes
measure: Sleep Quality
timeFrame: 20 minutes
measure: Psychological Well-being
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
state: Timis
Study officials:
affiliation: University of Medicine and Pharmacy "Victor Babes" Timisoara
name: Alexandru Crisan, PhD
role: PRINCIPAL_INVESTIGATOR
References: