Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492577
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-04
Brief Title:
Combined Pulmonary Rehabilitation and PMR for Long-Term COVID-19 Symptoms A RCT
Sponsor:
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr Victor Babeș Timișoara
Organization:
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr Victor Babeș Timișoara
Study Overview
Official Title:
Effectiveness of Combined Pulmonary Rehabilitation and Progressive Muscle Relaxation on Long-term COVID-19 Symptoms a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None