Physical ActivityNCT05115162
The Effects of the Hybrid Telerehabilitation Exercise in Inactive Students
A study testing Exercise in people with Physical Activity and Exercise, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Exercise
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ....>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
Who cannot join
- Having cancer, diabetes mellitus, pregnancy, infection, rheumatic pain
- Less than 85% attendance to the program
- Participating in any other physical activity program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of the Hybrid Telerehabilitation Exercise Program in Inactive University Students During Covid-19 Pandemic - A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Physical Activity, Exercise
- Being tested
- Exercise
- Keywords
- Hybrid Telerehabilitation, Sleep Quality, Depression, Physical Inactivity, Exercise
- Medical subject headings
- Motor Activity, Sleep Initiation and Maintenance Disorders, Depression, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| elerehablitation home exercise group | Experimental | 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. Receives: Other: Exercise |
| Control Group | No intervention | This group did not participate in any exercise program for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI):
Measurement of the sleep quality
Measured: At the baseline
Pittsburgh Sleep Quality Index
Measurement of the sleep quality
Measured: At the end of the 6th week
Secondary outcomes (7)
Beck Depression Inventory
Measurement of the depression level
Measured: At the baseline
Beck Depression Inventory
Measurement of the depression level
Measured: At the end of the 6th week
Short Form-12
Measurement of the quality of life
Measured: At the baseline
Short Form-12
Measurement of the quality of life
Measured: At the end of the 6th week
International Physical Activity Questionnaire-Short Form
Measurement of the physical activity
Measured: At the baseline
International Physical Activity Questionnaire-Short Form
Measurement of the physical activity
Measured: At the end of the 6th week
Adherence the exercise program
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.
Measured: At the end of the 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Dec 2020
- Primary completion17 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115162
- Sponsor's protocol ID
- 09.2021.170
- Status last verified
- Oct 2021
- First submitted
- 1 Nov 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Hybrid Telerehabilitation Exercise Program in Inactive University Students During Covid-19 Pandemic - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05115162
- Acronym / sponsor ID
- 09.2021.170
- Conditions
- Physical Activity, Exercise
- Keywords
- Hybrid Telerehabilitation, Sleep Quality, Depression, Physical Inactivity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elerehablitation home exercise group | Experimental | Other: ExerciseTelerehabilitation 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. |
| Control Group | No intervention | –This group did not participate in any exercise program for 6 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ....>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
Key exclusion criteria (3 listed)
- Having cancer, diabetes mellitus, pregnancy, infection, rheumatic pain
- Less than 85% attendance to the program
- Participating in any other physical activity program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | elerehablitation home exercise group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI):
Time frame: At the baseline
Measurement of the sleep quality
Pittsburgh Sleep Quality Index
Time frame: At the end of the 6th week
Measurement of the sleep quality
7 secondary outcomes
Beck Depression Inventory
Time frame: At the baseline
Beck Depression Inventory
Time frame: At the end of the 6th week
Short Form-12
Time frame: At the baseline
Short Form-12
Time frame: At the end of the 6th week
International Physical Activity Questionnaire-Short Form
Time frame: At the baseline
International Physical Activity Questionnaire-Short Form
Time frame: At the end of the 6th week
Adherence the exercise program
Time frame: At the end of the 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Physical Activity and Exercise, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI): (time frame: At the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.