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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, 34083

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05115162
Study groupRoleWhat they receive
elerehablitation home exercise groupExperimentalTelerehabilitation 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 GroupNo interventionThis 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.

  1. Pittsburgh Sleep Quality Index (PSQI):

    Measurement of the sleep quality

    Measured: At the baseline

  2. Pittsburgh Sleep Quality Index

    Measurement of the sleep quality

    Measured: At the end of the 6th week

Secondary outcomes (7)
  1. Beck Depression Inventory

    Measurement of the depression level

    Measured: At the baseline

  2. Beck Depression Inventory

    Measurement of the depression level

    Measured: At the end of the 6th week

  3. Short Form-12

    Measurement of the quality of life

    Measured: At the baseline

  4. Short Form-12

    Measurement of the quality of life

    Measured: At the end of the 6th week

  5. International Physical Activity Questionnaire-Short Form

    Measurement of the physical activity

    Measured: At the baseline

  6. International Physical Activity Questionnaire-Short Form

    Measurement of the physical activity

    Measured: At the end of the 6th week

  7. 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.

  1. First posted10 Nov 2021
  2. Study start1 Dec 2020
  3. Primary completion17 Jan 2021
  4. Study completion30 Apr 2021

Resources

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)
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

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.

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