Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000121763
Ethics application status
Approved
Date submitted
29/11/2021
Date registered
25/01/2022
Date last updated
25/07/2022
Date data sharing statement initially provided
25/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of remote online exercise training in individuals with COVID-19 disease.
Scientific title
Investigation of the effects of remote online exercise training in individuals who isolate themselves at home due to COVID-19 disease.
Secondary ID [1] 305905 0
Nil known
Universal Trial Number (UTN)
U1111-1272-0432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyspnea 324469 0
Fatigue 324470 0
Anxiety 324471 0
Depression 324472 0
balance problem 324473 0
decrease in functional mobility 324474 0
COVID-19 324475 0
Condition category
Condition code
Respiratory 321960 321960 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurements:
Before and after the exercise training applied for 4 weeks in total, all evaluations (including dyspnea, fatigue, anxiety, depression, balance and functional mobility) are being made as a one-to-one online interview by a specialist physiotherapist.
Physical exercise program:
Afterwards, all patients are being divided into training and control groups in which patients are performing different exercise programs via online video-conferencing.
*The following exercise program is being applied to the patients in the training group by another physiotherapist via one-to-one online video phone call, phone voice call and/or online video-conferencing with Microsoft Teams, depending on individuals' opportunities and availability, during 30-45 minutes per a day, 3 days per a week and totally 4-week:
-Thoracic Expansion Exercises
-Non-specific general body exercises with body weight
Moreover, a home program is being applied to the patients in the training group which is totally continuing during 30-45 minutes per a day. Verbal confirmation at end of online sessions is used to monitor adherence to the home program in the training group.
The home program for training group includes;
1) thoracic expansion exercises: 4 times a day and other days of week
2) same non-specific general body exercises with body weight (including squat, lunge, bridge,
extensions of hip, knee, elbow and upper body, shoulder flexion, shuttle pull and stretching exercises): on other days of the week, once a day
3) physical activity recommendation including walking in the room and/or home is being given to the patients.
Intervention code [1] 322302 0
Rehabilitation
Intervention code [2] 322450 0
Treatment: Other
Comparator / control treatment
*Patients in the control group are being given a single session by phone video call and/or online video-conferencing with Microsoft Teams in total 30-45 minutes, and thoracic expansion exercises are being taught as a home program in this session. The patients are being asked to do this exercise every day and 4 times per a day during 4 weeks. Moreover physical activity recommendation including walking in the room and/or home is also being given to these patients. Verbal confirmation via SMS text reminders at end of every week is used to monitor adherence to the home program in the control group. After 4 weeks of follow-up, it continues to be applied to these patients who want non-specific general body exercises with body weight.
Control group
Active

Outcomes
Primary outcome [1] 329717 0
Anxiety score evaluated using Hospital anxiety and Depression Scale (0-21)
Timepoint [1] 329717 0
Baseline, at 4 weeks after baseline evaluation
Primary outcome [2] 329718 0
Depression score evaluated using Hospital anxiety and Depression Scale (0-21)
Timepoint [2] 329718 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [1] 403578 0
Dyspnea perception evaluated using Medical Research Council Dyspnea Scale (0-4)
Timepoint [1] 403578 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [2] 403579 0
Fatigue score evaluated using Modified Borg scale (0-10)
Timepoint [2] 403579 0
Baseline, at every session, at 4 weeks after baseline evaluation
Secondary outcome [3] 403580 0
Effort intensity evaluated using Modified Borg Scale (0-10)
Timepoint [3] 403580 0
Baseline, at every session, at 4 weeks after baseline evaluation
Secondary outcome [4] 403581 0
Chronic fatigue level evaluated using Checklist Individual Strength Questionnaire
Timepoint [4] 403581 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [5] 403582 0
Balance score evaluated using Berg Balance Scale (0-56)
Timepoint [5] 403582 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [6] 403583 0
Functional mobility score evaluated using Chair Stand Test
Timepoint [6] 403583 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 have technology such as smart phone or computer, ipad, laptop etc. where surveys and exercises can be applied.
• Individuals with a positive Polymerase Chain Reaction (PCR) test result
• Individuals who are compatible with COVID-19 infection as a result of chest X-ray or lung tomography, although the PCR test result is negative.
• Individuals diagnosed with COVID-19 and self-isolating at home and following up for recovery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals with unstable angina pectoris, uncompensated heart failure, myocardial infarction in the past month, uncontrolled diabetes, hypertension above 180/110 mmHg, and/or severe neuropathy which may pose a risk during exercise practices
• Individuals diagnosed with COVID-19 and recovered by self-isolation at home
• 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
• Individuals with severe muscle spasm, involuntary weight loss, symptom inconsistency
• Individuals with severe dyspnea at rest and/or minimal effort, cyanosis, and/or hemoptysis

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
Sample size analysis prior to study (G*Power 3.0.10 system, Franz Faul, Universität Kiel, Germany) was performed to detect difference between two independent means/groups for an a value of 0.05, effect size of 1.09, 80% power, and at least 15 participants were calculated for each group.
All analyses will be conducted by using windows-based SPSS 15.0 statistical analysis program. Descriptive data will be stated as mean±standard deviation (X±SD), mean difference between groups (MD), 95% confidence interval (95%CI), median, interquartile range, frequency (n) and percentage (%). Tests of Student t, Mann Whitney U test and Chi-square will be employed to compare normally distributed, non-normally distributed and nominal data between groups, respectively. To investigate the impact of 4-week exercise training, ANCOVA which met the assumptions will be performed on outcomes whose baseline values will be used as covariates. Intention-to-treat analyses will be performed if there are dropouts. Post-hoc statistical power values for outcomes will be also presented. Bonferroni test will be used for manually adjusted post-hoc comparisons. Moreover, Cohen’s d, an effect size, will be calculated to represent the practical significance. The effect sizes of 0.20, 0.50 and greater than or equal to 0.80 will be considered as small, moderate, and large, respectively. A p-value below 0.05 will be considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2021
Date of last participant enrolment
Anticipated
28/02/2023
Actual
1/02/2022
Date of last data collection
Anticipated
28/03/2023
Actual
28/02/2022
Sample size
Target
30
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 24354 0
Turkey
State/province [1] 24354 0
Izmir

Funding & Sponsors
Funding source category [1] 310256 0
Self funded/Unfunded
Name [1] 310256 0
None
Country [1] 310256 0
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] 311352 0
Individual
Name [1] 311352 0
AYSE SEZGI KIZILIRMAK
Address [1] 311352 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] 311352 0
Turkey
Secondary sponsor category [2] 311358 0
Individual
Name [2] 311358 0
ELIF SAHIN
Address [2] 311358 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] 311358 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309928 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 309928 0
Ethics committee country [1] 309928 0
Turkey
Date submitted for ethics approval [1] 309928 0
Approval date [1] 309928 0
23/03/2021
Ethics approval number [1] 309928 0
2021/03-10

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

Contacts
Principal investigator
Name 115870 0
Dr GÜLSAH BARGI
Address 115870 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 115870 0
Turkey
Phone 115870 0
+905317938766
Fax 115870 0
+90 232 260 1004
Email 115870 0
[email protected]
Contact person for public queries
Name 115871 0
GÜLSAH BARGI
Address 115871 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 115871 0
Turkey
Phone 115871 0
+905317938766
Fax 115871 0
+90 232 260 1004
Email 115871 0
[email protected]
Contact person for scientific queries
Name 115872 0
GÜLSAH BARGI
Address 115872 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 115872 0
Turkey
Phone 115872 0
+905317938766
Fax 115872 0
+90 232 260 1004
Email 115872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant anonymized data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, ending 2 years following main results publication.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor and only interested parties or official institutions/organizations who want to access this, provide a sound methodologically justification.
Available for what types of analyses?
any purpose, only to achieve the aims in the approved proposal, for IPD meta-analyses, etc.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.