Long Covid19NCT06492577
Combined Pulmonary Rehabilitation and PMR for Long-Term COVID-19 Symptoms: A RCT
A study testing Pulmonary rehabilitation protocol and Progressive muscle relaxation protocol in people with Long Covid19 and Pulmonary Rehabilitation, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Long Covid19, Pulmonary Rehabilitation, Progressive Muscle Relaxation
- What is being tested?
- Pulmonary rehabilitation protocol and Progressive muscle relaxation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteRomania
- Study dates
- 15 Jul 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
Timișoara, Timiș County, 300301
About this study
Official title: Effectiveness of Combined Pulmonary Rehabilitation and Progressive Muscle Relaxation on Long-term COVID-19 Symptoms: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Pulmonary rehabilitation protocol, Progressive muscle relaxation protocol
- Keywords
- Long-COVID-19, Progressive Muscle Relaxation, Pulmonary Rehabilitation, Exercise Capacity, Anxiety Reduction
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation protocolOther
In the initial phase (days 1-7), aerobic exercise sessions will be 20-30 minutes, strength training will include 1-2 sets at 50% of 1RM, and breathing exercises will last 10 minutes daily. In the progressive phase (days 8-14), aerobic exercise sessions will increase to 30-40 minutes, strength training to 2-3 sets at 60% of 1RM, and breathing exercises to 10-15 minutes daily. In the advanced phase (days 15-21), aerobic exercise sessions will be 40-45 minutes, strength training will be 2-3 sets at 70% of 1RM, and breathing exercises will continue for 10-15 minutes daily.
Progressive muscle relaxation protocolOther
Participants in this arm will undergo a 21-day progressive muscle relaxation (PMR) program aimed at reducing anxiety and improving sleep quality in patients with long-term COVID-19 symptoms. Each daily session lasts 20 minutes and involves systematic muscle tensing and relaxation, starting from the feet and progressing to the head, combined with slow, deep breathing. During the initial phase (days 1-7), the focus is on introducing PMR techniques and targeting different muscle groups. In the progressive phase (days 8-14), full-body PMR sessions enhance relaxation and breathing techniques. The advanced phase (days 15-21) maximizes relaxation and incorporates visualization techniques.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation group | Active comparator | Participants in this arm will undergo a structured 21-day pulmonary rehabilitation (PR) program designed to improve lung function, exercise capacity, and overall physical health, conducted according to the 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 will be 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 will be performed for 10-15 minutes per session. Receives: Other: Pulmonary rehabilitation protocol |
| Progressive muscle relaxation group | Experimental | Participants in this group will receive additional progressive muscle relaxation techniques designed to reduce anxiety and improve sleep quality in patients with long-term COVID-19 symptoms. Each PMR session will last for 20 minutes and will involve systematic muscle tensing and relaxation, starting from the feet and progressing to the head, combined with slow, deep breathing. Receives: Other: Pulmonary rehabilitation protocol; Other: Progressive muscle relaxation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start15 Jul 2024
- Primary completion6 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexandru Crisan, PhD, Principal investigator, University of Medicine and Pharmacy "Victor Babes" Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492577
- Sponsor's protocol ID
- 4990
- Status last verified
- Dec 2024
- First submitted
- 4 Jul 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Pulmonary Rehabilitation and Progressive Muscle Relaxation on Long-term COVID-19 Symptoms: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06492577
- Acronym / sponsor ID
- 4990
- Keywords
- Long-COVID-19, Progressive Muscle Relaxation, Pulmonary Rehabilitation, Exercise Capacity, Anxiety Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș TimișoaraOther government
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation group | Active comparator | Other: Pulmonary rehabilitation protocolParticipants in this arm will undergo a structured 21-day pulmonary rehabilitation (PR) program designed to improve lung function, exercise capacity, and overall physical health, conducted according to the 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 will be 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 will be performed for 10-15 minutes per session. |
| Progressive muscle relaxation group | Experimental | Other: Pulmonary rehabilitation protocol, Other: Progressive muscle relaxation protocolParticipants in this group will receive additional progressive muscle relaxation techniques designed to reduce anxiety and improve sleep quality in patients with long-term COVID-19 symptoms. Each PMR session will last for 20 minutes and will involve systematic muscle tensing and relaxation, starting from the feet and progressing to the head, combined with slow, deep breathing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation protocolIn the initial phase (days 1-7), aerobic exercise sessions will be 20-30 minutes, strength training will include 1-2 sets at 50% of 1RM, and breathing exercises will last 10 minutes daily. In the progressive phase (days 8-14), aerobic exercise sessions will increase to 30-40 minutes, strength training to 2-3 sets at 60% of 1RM, and breathing exercises to 10-15 minutes daily. In the advanced phase (days 15-21), aerobic exercise sessions will be 40-45 minutes, strength training will be 2-3 sets at 70% of 1RM, and breathing exercises will continue for 10-15 minutes daily. | Other | Progressive muscle relaxation group, Pulmonary rehabilitation group |
| Progressive muscle relaxation protocolParticipants in this arm will undergo a 21-day progressive muscle relaxation (PMR) program aimed at reducing anxiety and improving sleep quality in patients with long-term COVID-19 symptoms. Each daily session lasts 20 minutes and involves systematic muscle tensing and relaxation, starting from the feet and progressing to the head, combined with slow, deep breathing. During the initial phase (days 1-7), the focus is on introducing PMR techniques and targeting different muscle groups. In the progressive phase (days 8-14), full-body PMR sessions enhance relaxation and breathing techniques. The advanced phase (days 15-21) maximizes relaxation and incorporates visualization techniques. | Other | Progressive muscle relaxation group |
Primary outcome
Lung function
Time frame: 20 minutes
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.
Exercise capacity
Time frame: 20 minutes
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.
Anxiety
Time frame: At inclusion and at the end of the study
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.
Depression
Time frame: 20 minutes
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.
Sleep Quality
Time frame: 20 minutes
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.
Psychological Well-being
Time frame: 20 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandru Crisan, PhD principal investigator
University of Medicine and Pharmacy "Victor Babes" Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation protocol and Progressive muscle relaxation protocol in people with Long Covid19 and Pulmonary Rehabilitation, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: 20 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.