- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115162
The Effects of the Hybrid Telerehabilitation Exercise in Inactive Students
The Effects of the Hybrid Telerehabilitation Exercise Program in Inactive University Students During Covid-19 Pandemic - A Randomized Controlled Study
Study Overview
Detailed Description
COVID-19 pandemic have caused multidimensional effects on people of all ages. Technology-based applications are widely using especially in education and health systems. The use of telerehabilitation services scope expanded throughout the pandemic. Precautions such as curfews and closing sports halls due to the pandemic have increased the time that being physically inactive in individuals. Since higher education continues with online systems and continuing stay home politics, positive or negative changes occurred in the lifestyles of students. It was shown activity, sleep, and psychological problems in young population. This problems are important because of their serious effects and comorbities, on pain, posture, and muscles. Exercise, sleep quality and quality of life are associated with each other a major proportion. Since inactivity and pandemic precautions, university students' quality of life and social life was disturbed negatively. On the other hand attendance the physical activity and exercise are important protective method for these negative situations. Therefore, this study planned to investigate the effects of home exercise program performed with the telerehabilitation method on sleep, depression, and quality of life on undergraduate students in the Covid-19 outbreak.
The population sample of the study consists of healthy sedentary individuals in the 18-65 age group. Gpower 3.1.9.7 software was used while calculating the sample size to be included in the study. The alpha error was 5%, the power of the study was 80%, and the effect size was 0.8. As a result of this calculation, taking into account the possibility of participants leaving the program, a total of 86 participants were included in the study and the study was completed with 63 people. Participants were randomly divided into 2 groups as 32 exercise group and 31 control group. Internet-based software (www.randomizer.org) was used for randomization. Both groups were evaluated at the beginning of the study and after 6 weeks. The exercise program was applied for 6 weeks. The exercises were repeated 3 days a week, 2 sets and each set with 10 repetitions. Two synchronized sessions were performed with the exercise group. In the first of these sessions, the content of the exercise program was explained. In the second, it was checked whether the exercises were done correctly. There were 3 days between synchronized sessions. No program was applied to the control group for 6 weeks, but at the end of the study, the same exercises given to the exercise group were also shown to the control group.
Exercise program consisted of indoor walking (30-minutes), flexibility, strengthening the shoulder and trunk muscles, bridge exercises, lying on the back, cycling and squatting.
Statistical Analysis: Independent Sample T Test was used to compare data with normal distribution between groups. To inter-group analysis, Paired Sample T Test was used and significance level was accepted as <0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34083
- Marmara University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ....>18 years old
- Pittsburg Sleep Quality Index total score >5 points
- No history of orthopedic, neurological, or cardiovascular disease
- Physical activity level < 600 MET-min-week according to International Physical Activity Questionnaire-Short From.
- Cooperative
- Not exposed to any telerehabilitation application
Exclusion Criteria:
- Having cancer, diabetes mellitus, pregnancy, infection, rheumatic pain
- Less than 85% attendance to the program
- Participating in any other physical activity program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: elerehablitation home exercise group
Telerehabilitation home exercise group received indoor walking and general exercise program for 6 weeks. Indoor walking was performed 3 days a week, for 30 minutes. General exercise program was consisted of flexibility, strengthening the shoulder and trunk muscles, bridge exercises, lying on the back, cycling and squatting exercises. All of the general exercises were repeated 3 days a week, 2 sets and each set with 10 repetitions. Two synchronized exercise education sessions were performed with the exercise group. In the first of these sessions, the content of the exercise program was explained. In the second, it was checked whether the exercises were done correctly. After synchronous education sessions, an asynchronous home exercise program, consisting walking and general exercise program continued for 6 weeks. |
The exercises consist of flexibility, strengthening exercises for the trunk and extremities, and walking indoors.The walking program was applied for at least 30 minutes.
Eight different exercises were given for the trunk and extremities and these exercises were applied 3 times a week, 2 sets, each set with 10 repetitions.
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NO_INTERVENTION: Control Group
This group did not participate in any exercise program for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI):
Time Frame: At the baseline
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Measurement of the sleep quality
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At the baseline
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Pittsburgh Sleep Quality Index
Time Frame: At the end of the 6th week
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Measurement of the sleep quality
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At the end of the 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Beck Depression Inventory
Time Frame: At the baseline
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Measurement of the depression level
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At the baseline
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Beck Depression Inventory
Time Frame: At the end of the 6th week
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Measurement of the depression level
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At the end of the 6th week
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Short Form-12
Time Frame: At the baseline
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Measurement of the quality of life
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At the baseline
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Short Form-12
Time Frame: At the end of the 6th week
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Measurement of the quality of life
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At the end of the 6th week
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International Physical Activity Questionnaire-Short Form
Time Frame: At the baseline
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Measurement of the physical activity
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At the baseline
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International Physical Activity Questionnaire-Short Form
Time Frame: At the end of the 6th week
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Measurement of the physical activity
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At the end of the 6th week
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Adherence the exercise program
Time Frame: At the end of the 6th week
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Attendance to the exercise program (for exercise group).
It was calculated at the end of the 6th week according to the percentage of completing the exercise sessions.
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At the end of the 6th week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09.2021.170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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