Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001538730
Ethics application status
Approved
Date submitted
5/12/2022
Date registered
13/12/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
13/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of exercise and physical activity in post-COVID-19 individuals.
Scientific title
Effectiveness of breathing exercises and physical activity counseling in individuals who have had COVID-19.
Secondary ID [1] 308547 0
Nil known
Universal Trial Number (UTN)
U1111-1285-7334
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low step count 328398 0
Dyspnea perception 328399 0
pain perception 328400 0
fatigue perception 328401 0
anxiety 328402 0
depression 328403 0
poor quality of life 328404 0
Condition category
Condition code
Infection 325426 325426 0 0
Other infectious diseases
Respiratory 325427 325427 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurements:
Before and after the exercise program applied for 4 weeks in total, all evaluations (including step count, dyspnea, pain, fatigue, anxiety, depression, and quality of life) are being made as a one-to-one face-to-face interview by a specialist physiotherapist. After the initial evaluation, all individuals are being divided into training and control groups.

The program for training group includes as below:
*Thoracic Expansion Exercises: It will be applied to individuals in an upright sitting position by the physiotherapist via one-to-one face-to-face session. In this position, individuals will place their hands on their lower ribs and then perform the cycle of "deep breathing + holding the deep breath for 3 seconds + slowly emptying all the breath" 3 times in a row. After this cycle, individuals will be asked to rest by taking 3-4 calm breaths. Immediately after, the individual will be asked to repeat the same cycle and repeat the cycle with calm breaths and rest until it reaches 10 repetitions. The individual will do this session 4 times a day. Individuals will do the first session of breathing exercises under supervision. In this way, incorrect exercise will be prevented. Other breathing exercise sessions will be done by individuals as a home program every day, 4 sessions a day and totally 4-week. Moreover, a home program is being applied to the individuals in the training group which is totally continuing during 30-60 minutes per a day. Verbal confirmation after phone interview is used to monitor adherence to the home program in the training group.

*Physical activity counseling: These individuals will be counseled by explaining physical activities immediately after the first evaluation. Physical activities; will consist of regularly walking outdoors, stepping inside the house, doing leisure activities, and/or doing housework.
Individuals will also be informed about the types of vigorous/moderate physical activity (basketball, volleyball, fitness, pilates, yoga, gardening, doing sports, etc.). Individuals will then be gradually accustomed to regular walking in order to increase their daily step count through weekly group phone messaging and, if necessary, direct phone calls. In the first week, individuals will be asked to walk for a total of 30-45 minutes a day, at least 4-5 days a week, and to increase the number of steps measured at the beginning by approximately 1000-2000 steps/day and reach at least 6500 steps/day. In the second week, individuals will be asked to add 2000-3000 steps to the number of daily steps taken in the previous week and reach at least 7500 steps/day. In the third week, individuals will be asked to reach at least 10000 steps/day by adding 3000-4000 steps to the daily steps they took in the previous week. In the last week, individuals will be asked to walk every day, reaching at least 10000 steps per day. General recommendations for safe physical activity such as not walking when hungry, walking 1-2 hours after meals, drinking water after walking will be explained to individuals. Individuals will record their daily step counts in their diaries every day.

*The home program for training group includes thoracic expansion exercises and physical activity recommendations.
Intervention code [1] 324994 0
Treatment: Other
Intervention code [2] 324995 0
Lifestyle
Comparator / control treatment
Individuals in this group will be asked to continue their normal daily living activities and will be followed up only with follow-up. At the end of four weeks, thoracic expansion exercises and physical activity counseling will be given to the individuals in the control group who volunteer to do exercise and physical activity, as it was done in the exercise group.
Control group
Active

Outcomes
Primary outcome [1] 333287 0
Daily step counts: Daily average step counts were recorded via a pedometer. All individuals were asked to carry their pedometers with them during the day and record to their diaries.
Timepoint [1] 333287 0
Baseline, at the end of everyday during 4-week and at 4 weeks after baseline evaluation (primary timepoint)
Primary outcome [2] 333294 0
Anxiety score obtained from Hospital Anxiety and Depression Scale (0-21)
Timepoint [2] 333294 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [1] 416523 0
Depression score obtained from Hospital Anxiety and Depression Scale (0-21)
Timepoint [1] 416523 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [2] 416524 0
Dyspnea perception evaluated using Medical Research Council Dyspnea Scale (0-4)
Timepoint [2] 416524 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [3] 416525 0
Pain score evaluated using Numarical Rating Scale (0-10)
Timepoint [3] 416525 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [4] 416526 0
Fatigue score evaluated using Numeraical Rating Scale (0-10)
Timepoint [4] 416526 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [5] 416527 0
Quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [5] 416527 0
Baseline, at 4 weeks after baseline evaluation

Eligibility
Key inclusion criteria
• Adult individuals aged 18 and over who volunteered to participate in the research
• Individuals who can understand and answer surveys
• Compatible individuals who can perform exercises and have good cooperation.
• Individuals who were diagnosed with COVID-19 (individuals with a positive Polymerase Chain Reaction (PCR) test result, compatible with COVID-19 infection as a result of lung X-ray or lung tomography despite negative PCR test results) and discharged after recovery/home quarantine completed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals newly diagnosed with COVID-19, therefore in quarantine at home or receiving treatment in hospital
• Individuals with suspected COVID-19
• Pregnant women
• Individuals with serious psychiatric illness and therefore unable to adapt to exercise sessions
• Individuals with severe cognitive impairment
• Individuals with ongoing orthopedic, neurological, cardiovascular disorders and/or problems which are independent of COVID-19

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients are being randomly grouped as either training group or control group using central randomisation by website.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation numbers created by a website.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2023
Actual
16/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
41
Final
Recruitment outside Australia
Country [1] 25168 0
Turkey
State/province [1] 25168 0
Izmir

Funding & Sponsors
Funding source category [1] 312795 0
Government body
Name [1] 312795 0
Scientific and Technological Research Council of Turkey (TUBITAK)
Country [1] 312795 0
Turkey
Primary sponsor type
Individual
Name
GÜLSAH BARGI
Address
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country
Turkey
Secondary sponsor category [1] 314431 0
Individual
Name [1] 314431 0
SENA UYGUNLAR
Address [1] 314431 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [1] 314431 0
Turkey
Secondary sponsor category [2] 314447 0
Individual
Name [2] 314447 0
GÜLCAN POLAT
Address [2] 314447 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [2] 314447 0
Turkey
Secondary sponsor category [3] 314448 0
Individual
Name [3] 314448 0
DILAN SU AKTAS
Address [3] 314448 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [3] 314448 0
Turkey
Secondary sponsor category [4] 314449 0
Individual
Name [4] 314449 0
UGUR CANBULAT
Address [4] 314449 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [4] 314449 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312082 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 312082 0
Ethics committee country [1] 312082 0
Turkey
Date submitted for ethics approval [1] 312082 0
09/06/2022
Approval date [1] 312082 0
24/06/2022
Ethics approval number [1] 312082 0
2022/07-05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123406 0
Dr GÜLSAH BARGI
Address 123406 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 123406 0
Turkey
Phone 123406 0
+905317938766
Fax 123406 0
+90 232 260 1004
Email 123406 0
[email protected]
Contact person for public queries
Name 123407 0
GÜLSAH BARGI
Address 123407 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 123407 0
Turkey
Phone 123407 0
+902322601001
Fax 123407 0
+90 232 260 1004
Email 123407 0
[email protected]
Contact person for scientific queries
Name 123408 0
GÜLSAH BARGI
Address 123408 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 123408 0
Turkey
Phone 123408 0
+902322601001
Fax 123408 0
+90 232 260 1004
Email 123408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I can not share the data of individuals included in the study in our country within the scope of the personal data protection law.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.