Clinical trial NCT05115162: The Effects of the Hybrid Telerehabilitation Exercise in Inactive Students
Official title: The Effects of the Hybrid Telerehabilitation Exercise Program in Inactive University Students During Covid-19 Pandemic - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Exercise
Keywords: Hybrid Telerehabilitation
Sleep Quality
Depression
Physical Inactivity
Exercise
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to examine the effects of a 6-week hybrid telerehabilitation exercise program on sleep quality, depression and quality of life of university students with physical inactivity.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI):
timeFrame: At the baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: At the end of the 6th week
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: At the baseline
measure: Beck Depression Inventory
timeFrame: At the end of the 6th week
measure: Short Form-12
timeFrame: At the baseline
measure: Short Form-12
timeFrame: At the end of the 6th week
measure: International Physical Activity Questionnaire-Short Form
timeFrame: At the baseline
measure: International Physical Activity Questionnaire-Short Form
timeFrame: At the end of the 6th week
measure: Adherence the exercise program
timeFrame: At the end of the 6th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: