The effect of pulmonary rehabilitation on depression, anxiety, fatigue and quality of life in COVID-19 patients with one-month follow-up
Design
Clinical trial with parallel control group, randomized, on 40 patients
Settings and conduct
The COVID-19 wards of Imam Khomeini Hospital in Sari were selected as the sampling site. 40 patients were admitted to the study with satisfaction and based on random allocation will be divided into two groups of intervention and control. For each group, questionnaires were completed at regular intervals and 60 interventions, one minute daily will be done at home for 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with COVID-19 and under 75 years of age. No history for other chronic diseases such as heart, orthopedic and motor disorders, diabetes, multiple sclerosis and cancer that interfere with the rehabilitation program. Exclusion criteria: asthma and any underlying lung disease are neuromuscular diseases that affect lung function.
Intervention groups
1-Pulmonary rehabilitation group; 2- Control group. In the pulmonary rehabilitation group, the patient will be asked to perform 3 sessions per week, 60 minutes per session including (warm-up, aerobic exercise, strength training, balance training and cooling) for 6 weeks after discharge from the hospital according to the program protocol. Control group: this group will perform their usual treatments according to the doctor's instructions. Pulmonary rehabilitation will not be performed in these people for 6 weeks.
Main outcome variables
Assess the severity of shortness of breath during daily activities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191125045496N3
Registration date:2021-01-25, 1399/11/06
Registration timing:retrospective
Last update:2021-01-25, 1399/11/06
Update count:0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
Mostafa Behzad Khamslo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 9230
Email address
mostafabehzadkh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
2020-04-29, 1399/02/10
Actual recruitment end date
2020-09-15, 1399/06/25
Trial completion date
2020-10-01, 1399/07/10
Scientific title
The Effect of Pulmonary Rehabilitation on Depression, Anxiety, Fatigue and Quality of Life in COVID-19 Patients with one-month Follow-up
Public title
Evaluation of the Effect of Pulmonary Rehabilitation in COVID-19 Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
COVID-19 Patients aged 35 to 75 years old
No history of chronic diseases such as heart, orthopedic and motor disorders, diabetes, multiple sclerosis and cancer that interfere with the rehabilitation program
The ability to use the technology or caregiver that made it possible for him to be quarantined
Exclusion criteria:
Asthma and any underlying lung disease are neuromuscular diseases that affect lung function.
Lack of patient cooperation and lack of motivation
Taking antidepressants and anti-anxiety drugs two months before the intervention
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method was performed based on random permutation blocks with 4 samples in each block and a random list of data was obtained using Random Allocation software.
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Province
Mazandaran
Postal code
4817875816
Approval date
2020-05-13, 1399/02/24
Ethics committee reference number
IR.MAZUMS..REC.1399.7588
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Quality of Life
Timepoint
At baseline (before intervention) and 6 weeks after intervention
Method of measurement
Short Form Quality of Life Questionnaire (SF-36)
2
Description
Anxiety and Depression scale
Timepoint
At baseline (before intervention) and 6 weeks after intervention
Method of measurement
Hospital Anxiety Depression scale (HADS)
3
Description
Fatigue scale
Timepoint
At baseline (before intervention) and 6 weeks after intervention
Intervention group: Pulmonary Rehabilitation Group:For this group, 3 training sessions and each session for 60 minutes of pulmonary rehabilitation program will be given face to face and individually. At the end of the third session, an educational illustrated booklet containing the educational content will be provided to patients and the patient After discharge from the hospital, they will be required to perform 3 sessions per week, each session lasting 60 minutes (warm-up, aerobic exercise, strength training, balance training, and cooling) for 6 weeks.
Category
Rehabilitation
2
Description
Control group: This group will perform their usual treatments according to the doctor's instructions. Pulmonary rehabilitation will not be performed in these people for 6 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Sari
Full name of responsible person
Mostafa Behzad Khamslo
Street address
Imam Khomeini Hospital., Amir Boulevard., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9231
Email
mostafabehzadkh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saiedi
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4854
Fax
Email
pajoheshi@mazums.ac.ir
Web page address
https://pajooheshi.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Proportion provided by this source
20
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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Hosseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Hospital., Amir Mazandaran St., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9231
Email
hosseinish20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Behzad Khamslo
Position
Teaching
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Email
mostafabehzadkh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Behzad Khamslo
Position
Teaching
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
7 km of sea road, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Email
mostafabehzadkh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available