Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000033741
Ethics application status
Approved
Date submitted
8/09/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Date results information initially provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical activity counseling in students during COVID-19
Scientific title
Effectiveness of physical activity counseling in university students educated by distance learning during COVID-19 pandemic: a randomized-controlled trial.
Secondary ID [1] 305262 0
Nil known
Universal Trial Number (UTN)
U1111-1271-0761
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low step count 323541 0
Physical inactivity 323542 0
Anxiety 323543 0
Depression 323544 0
Poor quality of Life 323545 0
Condition category
Condition code
Mental Health 321103 321103 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical activity counseling (PAC):
A 4-week PAC based on increasing daily step counts was performed by an experienced (>5 years) physiotherapist in university students. The PAC consisted of regular outdoor walking, stepping inside the home, doing leisure activities and/or doing housework. While students in training group were informed about types of physical activities including vigorous/moderate physical activities (basketball, volleyball, fitness, pilates, yoga, gardening, doing sports, etc.), outdoor walking, stepping inside the home, doing leisure activities and/or doing housework, students in control group were asked to continue their normal daily living activities. During 4-week, students in each group were remotely followed up via mailing for the diaries and daily step counts, telephone texting for the weekly connection about physical activities and direct 5-10 min telephone call when a student could not be reached by mail and/or telephone texting. At the end of 4-week, students in control group were similarly informed about types of physical activities and directed to increase daily step counts like training group.
Students in training group were gradually gotten accustomed to regular walking with the aim of increasing daily step counts through weekly group telephone texting and direct 5-10 min telephone call if necessary. However, both online course hours during the day and curfew for under 20 ages related with COVID-19 pandemic restrictions were considered. Therefore, students were not forced to walk outside. While eligible students took a walk outside, ineligible students took short walks to reach 10000 steps/d at home for at least 10 min at a time and 3-8 times/day. In the first week, the students were asked to walk for totally 30 min in a day, minimum 3 days per non-consecutive weekdays and increase their baseline daily step count by approximately 500-1000 steps/d. In the second week, students were asked to add 500-1000 steps on daily step counts taken in previous week and reach 7500 steps/d. In the third week, students were asked to add 2000 steps on daily step counts taken in previous week and reach 10000 steps/d. In last week, students were asked to walk over 10000 steps for everyday. The students were instructed about general recommendations for safe physical activity such as not walking when hungry, taking a walk 1-2 hours after meals, drinking water after walking and walking using a mask. The students recorded their daily step counts in their diaries every day.
Intervention code [1] 321655 0
Treatment: Other
Intervention code [2] 321657 0
Lifestyle
Comparator / control treatment
Students in control group keeped on their normal daily living activities during 4-week. At the end of 4-week, students in control group were similarly informed about types of physical activities and directed to increase daily step counts like treatment group. Students in control group were gradually gotten accustomed to regular walking with the aim of increasing daily step counts through weekly group telephone texting and direct 5-10 min telephone call if necessary.
Control group
Active

Outcomes
Primary outcome [1] 328880 0
Weekly step counts: Weekly average step counts were recorded via pedometer applications installed on smartphones. All students were asked to carry their smartphones with them during the day and they recorded their number of steps in diaries.
Timepoint [1] 328880 0
Baseline, at the end of 1. week, 2. week, 3. week, and at 4 weeks after baseline evaluation (primary timepoint)
Primary outcome [2] 329453 0
Daily step counts: Daily average step counts were recorded via pedometer applications installed on smartphones. All students were asked to carry their smartphones with them during the day and record to their diaries.
Timepoint [2] 329453 0
Baseline, at the end of everyday during 4-week and at 4 weeks after baseline evaluation (primary timepoint)
Secondary outcome [1] 400769 0
Time spent for walking during last 7-day (MET-min/week) evaluated using Short form of International Physical Activity Questionnaire
Timepoint [1] 400769 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [2] 400770 0
Time spent for moderate physical activities during last 7-day (MET-min/week) evaluated using Short form of International Physical Activity Questionnaire
Timepoint [2] 400770 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [3] 400771 0
Time spent for vigorous physical activities during last 7-day (MET-min/week) evaluated using Short form of International Physical Activity Questionnaire
Timepoint [3] 400771 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [4] 400772 0
Time spent for sitting during a day (hours/day) evaluated using Short form of International Physical Activity Questionnaire
Timepoint [4] 400772 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [5] 400773 0
Time spent for total physical activities during last 7-day (MET-min/week) evaluated using Short form of International Physical Activity Questionnaire
Timepoint [5] 400773 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [6] 400774 0
Beck Anxiety Inventory score (0-63)
Timepoint [6] 400774 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [7] 400775 0
Beck Depression Inventory score (0-63)
Timepoint [7] 400775 0
Baseline, at 4 weeks after baseline evaluation
Secondary outcome [8] 400776 0
Quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [8] 400776 0
Baseline, at 4 weeks after baseline evaluation

Eligibility
Key inclusion criteria
Inclusion criteria were
*volunteering to participate in the study,
*being a university student actively educated by distance learning
*being greater than or equal to 18 years
*having a smartphone or pedometer providing knowledge about daily step counts.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria were
*having any physical disability, infection, cooperation problem, severe asthma, an orthopedic or a neurological disease which would prevent doing regular physical activity
*being in a quarantine situation.

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 students were 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 2.17, 95% power, and at least 7 participants were calculated for each group.
All analyses were conducted by using windows-based SPSS 15.0 statistical analysis program. Descriptive data were stated as mean±standard deviation (X±SD), mean difference between groups (MD), 95% confidence interval (95%CI), frequency (n) and percentage (%). Tests of Student t and Chi-square were employed to compare normally distributed and nominal data between groups, respectively. Wilcoxon test was also used for the comparison of final and the first physical activity, anxiety, and depression levels for each group. To investigate the impact of 4-week PAC, ANCOVA which met the assumptions was performed on outcomes whose baseline values were used as covariates. Intention-to-treat analyses was not performed since there were no dropouts. Post-hoc statistical power values for outcomes were also presented. Bonferroni test was used for manually adjusted post-hoc comparisons. Moreover, Cohen’s d, an effect size, was calculated to represent the practical significance. The effect sizes of 0.20, 0.50 and greater than or equal to 0.80 were considered as small, moderate, and large, respectively. A p-value below 0.05 was considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/12/2020
Date of last participant enrolment
Anticipated
Actual
6/01/2021
Date of last data collection
Anticipated
Actual
11/03/2021
Sample size
Target
14
Accrual to date
Final
31
Recruitment outside Australia
Country [1] 24105 0
Turkey
State/province [1] 24105 0
Izmir

Funding & Sponsors
Funding source category [1] 309631 0
Self funded/Unfunded
Name [1] 309631 0
None
Country [1] 309631 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] 310652 0
None
Name [1] 310652 0
Address [1] 310652 0
Country [1] 310652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309406 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 309406 0
Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Ethics committee country [1] 309406 0
Turkey
Date submitted for ethics approval [1] 309406 0
Approval date [1] 309406 0
16/12/2020
Ethics approval number [1] 309406 0
2020/24-4

Summary
Brief summary
At the process of COVID-19 pandemic, daily step counts dramatically decreased approximately 67.7% from 8525 steps/d in pre-COVID-19 quarantine to 2754 steps/d during COVID-19 quarantine in young adults. That is, physical inactivity became another pandemic accompanying COVID-19 pandemic. Therefore, since the beginning of COVID-19, there have been some efforts to help individuals be physically active during COVID-19. Numerous fitness centers and trainers have been giving free online physical fitness programs via social media, video-conference and other channels and reviews related physical inactivity and recommendations about appropriate physical activities for healthy life have been presented. On the other hand, a study resulted in positive improvements in depression and stress scores after 4-week online mindfulness yoga practice in university students during COVID-19 pandemic. Moreover, doing regular exercise at moderate intensity and being physically active provide both potential behavior change and many benefits to human health in healthy individuals and patients with chronic diseases. These are decreased adipose tissue, increased cardio-respiratory fitness level, and metabolic homeostasis, interaction with immunoregulatory hormones that affects immune response and suppression of active inflammation. Furthermore, exercise can modify white cells distribution, phenotype and cytokine production. It therefore plays an important role to affect susceptibility to infection and prevent cardiovascular diseases and viral respiratory diseases like COVID-19. However, there is no prospective randomized controlled study investigating effectiveness of physical activity counseling (PAC) in university students, to our knowledge. Therefore, in current study, it was planned to investigate the effects of online PAC based on increasing daily step counts on daily average step counts, physical activity level, anxiety, depression and/or QOL in university students.
Trial website
Trial related presentations / publications
The abstract of this study was presented as an oral presentation in the II. INTERNATIONAL "BASKENT" CONGRESS ON PHYSICAL, SOCIAL AND HEALTH SCIENCES on 24.09.2021, in Turkey.
Public notes

Contacts
Principal investigator
Name 114046 0
Dr GÜLSAH BARGI
Address 114046 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 114046 0
Turkey
Phone 114046 0
+90 5317938766
Fax 114046 0
+90 232 260 1004
Email 114046 0
gulsah.bargi@idu.edu.tr
Contact person for public queries
Name 114047 0
Dr GÜLSAH BARGI
Address 114047 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 114047 0
Turkey
Phone 114047 0
+90 5317938766
Fax 114047 0
+90 232 260 1004
Email 114047 0
gulsah.bargi@idu.edu.tr
Contact person for scientific queries
Name 114048 0
Dr GÜLSAH BARGI
Address 114048 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 114048 0
Turkey
Phone 114048 0
+90 232 260 1001
Fax 114048 0
+90 232 260 1004
Email 114048 0
gulsah.bargi@idu.edu.tr

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.