ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

U1111-1272-0432

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dyspnea

Fatigue

Anxiety

Depression

balance problem

decrease in functional mobility

COVID-19

Condition category

Condition code

Respiratory

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]

Rehabilitation

Intervention code [2]

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]

Anxiety score evaluated using Hospital anxiety and Depression Scale (0-21)

Timepoint [1]

Baseline, at 4 weeks after baseline evaluation

Primary outcome [2]

Depression score evaluated using Hospital anxiety and Depression Scale (0-21)

Timepoint [2]

Baseline, at 4 weeks after baseline evaluation

Secondary outcome [1]

Dyspnea perception evaluated using Medical Research Council Dyspnea Scale (0-4)

Timepoint [1]

Baseline, at 4 weeks after baseline evaluation

Secondary outcome [2]

Fatigue score evaluated using Modified Borg scale (0-10)

Timepoint [2]

Baseline, at every session, at 4 weeks after baseline evaluation

Secondary outcome [3]

Effort intensity evaluated using Modified Borg Scale (0-10)

Timepoint [3]

Baseline, at every session, at 4 weeks after baseline evaluation

Secondary outcome [4]

Chronic fatigue level evaluated using Checklist Individual Strength Questionnaire

Timepoint [4]

Baseline, at 4 weeks after baseline evaluation

Secondary outcome [5]

Balance score evaluated using Berg Balance Scale (0-56)

Timepoint [5]

Baseline, at 4 weeks after baseline evaluation

Secondary outcome [6]

Functional mobility score evaluated using Chair Stand Test

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Izmir

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

None

Address [1]

None

Country [1]

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]

Individual

Name [1]

AYSE SEZGI KIZILIRMAK

Address [1]

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]

Turkey

Secondary sponsor category [2]

Individual

Name [2]

ELIF SAHIN

Address [2]

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]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee

Ethics committee address [1]

Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

23/03/2021

Ethics approval number [1]

2021/03-10

Summary

Brief summary

Studies in the literature agree on the necessity of rehabilitation practices and exercises for individuals with COVID-19. However, studies on this subject mostly remained at the level of compilation. The rapid spread and serious mortality and morbidity rates of COVID-19 are cited as the justified reasons for this. Since life changes very rapidly in this rapidly developing process, there are still a very limited number of prospective studies on these patients. Liu et al. applied respiratory muscle training, coughing exercises, diaphragmatic training, stretching exercises and home exercise programs for a total of 6 weeks in the form of 2 sessions/week within the scope of respiratory rehabilitation to elderly patients with COVID-19. Ultimately, respiratory function, quality of life, and anxiety improved in elderly patients with COVID-19 undergoing respiratory rehabilitation; however, no statistically significant change was observed in depression and activities of daily living. In another study planned by Gonzalez-Gerez et al., but whose results have not yet been published, it was planned to investigate the effects of home breathing exercises, non-specific exercises, and mental exercises in patients diagnosed with COVID-19. No other prospective studies have been found in the literature on the application and results of home exercise protocols in the acute period in individuals with mild COVID-19. For this reason, the aim of this study is to determine the dyspnea, fatigue, anxiety, depression, balance and lower extremity muscle functions of these individuals with an exercise training program consisting of respiratory and non-specific general body exercises applied remotely for four weeks to individuals who are self-isolating at home due to COVID-19 disease. to investigate its effects.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr 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

Phone

+905317938766

Fax

+90 232 260 1004

gulsah.bargi@idu.edu.tr

Contact person for public queries

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

Phone

+905317938766

Fax

+90 232 260 1004

gulsah.bargi@idu.edu.tr

Contact person for scientific queries

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

Phone

+905317938766

Fax

+90 232 260 1004

gulsah.bargi@idu.edu.tr

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 (gulsahbargi@gmail.com)

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.

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