1. Home
  2. Approved trials
  3. » فارسی

Enhancing Symptom Management in Long-COVID 19 Patients: A Comparative Study of Pulmonary Rehabilitation and Progressive Muscle Relaxation Techniques

Protocol summary

Study aim
The objective of this study was to investigate the effects of pulmonary rehabilitation and additional progressive muscle relaxation techniques in patients with long-COVID 19 symptoms.
Design
We included 61 post-COVID-19 patients who came for pulmonary rehabilitation. The pulmonary rehabilitation program lasted for 21 days. In the order in which they came to admission, patients were randomly allocated into two groups: one group followed the PR program, while the other group underwent the PR program along with a PMR. The intervention group engaged in additional daily 20-minute PMR sessions.
Settings and conduct
The study was performed at a single pulmonary rehabilitation center in Timisoara, Romania. All the included patients received pulmonary rehabilitation. The intervention group received additional PMR.
Participants/Inclusion and exclusion criteria
The inclusion criteria were: previous infection with COVID-19, age over 18 years, primary symptom of dyspnea and fatigability lasting for over one month, motivation, and willingness to participate in the program. Exclusion criteria: severe heart disease, severe acute illness, other lung diseases, patient refusal, severe cognitive impairment.
Intervention groups
The intervention group engaged in additional daily 20-minute PMR sessions focusing on progressively tensing and then relaxing major muscle groups, starting from the hands and moving up through the body, while maintaining slow, deep breathing.
Main outcome variables
GAD-7 will improve, PSQI will improve

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231115060065N3
Registration date: 2023-12-06, 1402/09/15
Registration timing: retrospective

Last update: 2023-12-06, 1402/09/15
Update count: 0
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Alexandru Florian Crișan
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Country
Romania
Phone
+40 765 525 688
Email address
crisan@umft.ro
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-01, 1402/03/11
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
2023-06-01, 1402/03/11
Actual recruitment end date
2023-06-01, 1402/03/11
Trial completion date
2023-11-01, 1402/08/10
Scientific title
Enhancing Symptom Management in Long-COVID 19 Patients: A Comparative Study of Pulmonary Rehabilitation and Progressive Muscle Relaxation Techniques
Public title
Progressive muscle relaxation techniques in patients with COVID-19 symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Previous infection with COVID-19 Age over 18 years Primary symptom of dyspnea and fatigability lasting for over one month
Exclusion criteria:
Severe heart disease Severe ischemic or hemorrhagic stroke Severe cognitive impairment Medication that could potentially affect their exercise responses
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 65
Actual sample size reached: 61
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomized to either an interventional group or a control group according to their moment of admission. The patients who were admitted to the study at the same time were assigned to different treatment groups. This method of randomization was used to ensure that the patients in the two groups were similar in terms of their time of admission, which could affect the outcome of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Comisia de Etică a Spitalului de Boli Infectioase si Pneumoftiziologie Victor Babes Timisoara
Street address
Gheorghe Adam nr. 13
City
Timisoara
Postal code
300310
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
4990

Health conditions studied

1

Description of health condition studied
Post COVID-19 condition
ICD-10 code
U09.9
ICD-10 code description
Post COVID-19 condition, unspecified

Primary outcomes

1

Description
Reduced general anxiety level
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
GAD-7 questionnaire

Secondary outcomes

1

Description
Improved sleep quality
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
PSQI questionnaire

2

Description
Improved overall health
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
GHQ-12 questionnaire

Intervention groups

1

Description
Intervention group: pulmonary rehabilitation and additional progressive muscle relaxation techniques. The patients performed the pulmonary rehabilitation program for 21 days, twice a day. The pulmonary rehabilitation program included: gradual aerobic conditioning, strength training focusing on the major muscle groups, and breathing exercises with an emphasis on pursed lip breathing, double inhale breathing, and chest expansion exercises. The intervention group engaged in additional daily 20-minute PMR sessions focusing on progressively tensing and then relaxing major muscle groups, starting from the hands and moving up through the body, while maintaining slow, deep breathing. The program involved tensing the muscle group for 5 seconds and then releasing and relaxing for 20 seconds.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinical Hospital of Infectious Diseases and Pulmonology, Victor Babes Timisoara, Romania
Full name of responsible person
Crisan Alexandru Florian
Street address
Eftimie Murgu
City
Timisoara
Postal code
300041
Phone
+40 765 525 688
Email
crisan@umft.ro

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Crisan Alexandru
Street address
Eftimie Murgu
City
Timisoara
Postal code
300041
Phone
+40 765 525 688
Email
crisan@umft.ro
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medicine and Pharmacy Victor Babes Timisoara
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Crisan Alexandru Florian
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Eftimie Murgu
City
Timisoara
Province
Timis
Postal code
300041
Phone
+40 765 525 688
Email
crisan@umft.ro

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Crisan Alexandru Florian
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Eftimie Murgu
City
Timisoara
Province
Timis
Postal code
300041
Phone
+40 765 525 688
Email
crisan@umft.ro

Person responsible for updating data

Contact
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Crisan Alexandru Florian
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Eftimie Murgu
City
Timisoara
Province
Timis
Postal code
300041
Phone
+40 765 525 688
Email
crisan@umft.ro

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...