Regular Physical ActivityNCT06329115
Investigation of the Effectiveness of Regular Physical Activity in University Students
A study testing Exercise training in people with Regular Physical Activity and Exercise, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Regular Physical Activity, Exercise
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2024to 30 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students who choose the course offered within the scope of university-wide elective courses
- No obstacle to aerobic exercise
- No chronic disease
- Individuals who have no history of surgery on the lower extremity in the last 6 months
Who cannot join
- Individuals who do not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Şahinbey, 27100
About this study
Official title: Investigation of the Effectiveness of Regular Physical Activity in University Students Within the Scope of a Course
In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices.
Read the detailed description
Physical activity; They are body movements made using skeletal muscles in daily life and resulting in energy expenditure. In addition to daily living activities such as playing games, doing housework, walking, eating, and bathing, exercise and sports are also included in this definition. Physical activity is very important for a healthy life. Studies have reported that continuing physical activity, especially during growth and young adulthood, has positive effects on aerobic capacity, blood pressure, body composition, glucose metabolism, skeletal health and psychological health. Studies have reported that physical activity affects social and personal success in healthy adult individuals and is associated with sleep quality and depression. In this context, our work; After regular physical activity, university students who code the course from various faculties and departments within the scope of the university-wide free elective course; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices.
Hypotheses of the study;
- Regular physical activity improves lifelong learning tendencies in university students.
- Regular physical activity increases the level of physical activity in university students.
- Regular physical activity reduces fatigue levels in university students.
- Regular physical activity reduces daytime sleepiness in university students.
- Regular physical activity improves depression, anxiety and stress levels in university students.
- Regular physical activity improves the quality of life in university students.
- Regular physical activity improves functional capacity and increases walking distance in university students.
- Regular physical activity reduces the physiological expenditure index in university students.
- Conditions
- Regular Physical Activity, Exercise
- Being tested
- Exercise training
- Keywords
- Physical acitivity, Depression, Anxiety, Sleep quality, Health life learning, Quality of life, Functional capasity, physiological expenditure
- Medical subject headings
- Motor Activity, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Within the physical activity program, an aerobic training program will be applied to students for a total of 150 minutes per week for 8 weeks. Aerobic training includes moderate-intensity walking exercise. The concept of moderate walking will be explained to individuals at the beginning of the study. Maximal and submaximal heart rate calculations will be made with the formulas (220-age) / (220-age X 0.6) and this heart rate will be maintained throughout the training. Students will have a pedometer application installed on their phones and their step counts and exercise minute data will be recorded. At the same time, in order for students to use their respiratory functions properly during regular walking, diaphragmatic breathing and alternating nose breathing breathing exercises will be taught and they will be instructed to do them once a day with 5 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | This group will get aerobic exercise programme and respiratory exercise Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifelong learning
Lifelong learning processes will be evaluated with the "Lifelong Learning Tendencies Scale" developed by Coşkun in 2009. The 6-point Likert scale (1 = fits a lot, 6 = doesn't fit at all) consists of 27 items and 4 sub-dimensions. It consists of subheadings: Motivation in Lifelong Learning (6 items), Persistence (6 items), Lack of Regulating Learning (6 items), Lack of Curiosity (9 items). The lowest score that can be obtained from the first three dimensions of the scale is 6 (6x1), the middle score (6x3.5) is 21, and the highest score (6x6) is 36. The last dimension, lack of curiosity, was determined as the lowest score (9x1) 9, the middle score (9x3.5) 31.5 and the highest score (9x9) 81 points. In the overall average of the scale, the minimum score that can be obtained from the scale (27x1) is 27, the median score (27x3.5) is 94.5, and the maximum score (27x6) is 162.
Measured: through of the study, average 8 week
Physical activity
International Physical Activity Questionnaire-Short Form (IPAQ) will be used to evaluate physical activity. International Physical Activity Survey Short form (7 questions); It provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. The energy required for activities is calculated with the MET-minute score. Standard MET values have been established for these activities. Using these values, daily and weekly physical activity levels are calculated.
Measured: through of the study, average 8 week
Fatique
Fatigue levels Gencay et al. It will be evaluated with the "Fatigue Severity Scale", the validity and reliability of which was established in 2012. The scale consists of 9 items. The lowest score that can be achieved among the scale items is 0 and the highest score is 7. As the score increases, the severity of fatigue increases.
Measured: through of the study, average 8 week
Daytime sleepiness
Daytime sleepiness levels of students were developed by John in 1992 and Izci et al. in 2008. It will be evaluated with the "Epworth Sleepiness Scale", whose validity and reliability has been established by. The scale consists of 8 items, the lowest score to be obtained from the scale is 0 and the highest score is 24. As the score increases, the level of daytime sleepiness increases.
Measured: through of the study, average 8 week
Depression, anxiety and stress
Depression, anxiety and stress levels will be evaluated with the "Depression, anxiety and stress scale". The validity and reliability study of the scale was conducted by Sarıçam in 2018. The scale, consisting of 21 items, is scored between 0-3. As the score increases, depression, anxiety and stress levels increase.
Measured: through of the study, average 8 week
Quality of life measurement
The quality of life of students was evaluated by Demiral et al. in 2006. It will be evaluated with the "SF-36 Short Form", whose validity and reliability studies have been conducted by. The survey, which consists of 36 items, includes 8 sub-parameters.Scoring is evaluated separately for each sub-dimension. The total score of the scale is not calculated. In the scale, questions 1, 2 and 11 are about general health, questions 3 are about physical functions, question 4 is about physical role limitation, questions 5 are about emotional role limitation, questions 6 and 10 are about social functions, questions 7 and 8 are about pain, questions 9 are about pain. Statements a, e, g and i of the question question vitality, expressions b, c, d, f and h question mental health. Each subscale is scored between 0 and 100. An increase in the dimension mean score indicates that the quality of life is high in that parameter.
Measured: through of the study, average 8 week
Physiological expenditure indices
The students' resting heart rates and walking heart rates were measured with a pulse oximeter. Physiological expenditure indices will be calculated with the formula = (Heart rate during walking - Resting heart rate) / Walking speed (m/min).
Measured: through of the study, average 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start25 Mar 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Regular Physical ActivityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be included in an 8-week regular exercise program. Evaluations will be made before and after exercise.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba GÖNEN, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329115
- Sponsor's protocol ID
- 2024/23
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sallis JF, Prochaska JJ, Taylor WC. A review of correlates of physical activity of children and adolescents. Med Sci Sports Exerc. 2000 May;32(5):963-75. doi: 10.1097/00005768-200005000-00014.
PubMed 10795788Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
PubMed 16534088Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
PubMed 22818936Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJ, Ezzati M. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009 Apr 28;6(4):e1000058. doi: 10.1371/journal.pmed.1000058. Epub 2009 Apr 28.
PubMed 19399161Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71 Suppl 2:114-20. doi: 10.1080/02701367.2000.11082794. No abstract available.
PubMed 25680021
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Regular Physical Activity in University Students Within the Scope of a Course
- ClinicalTrials.gov ID
- NCT06329115
- Acronym / sponsor ID
- 2024/23
- Conditions
- Regular Physical Activity, Exercise
- Keywords
- Physical acitivity, Depression, Anxiety, Sleep quality, Health life learning, Quality of life, Functional capasity, physiological expenditure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Mar 2024 (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.
In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices.
Detailed description
Physical activity; They are body movements made using skeletal muscles in daily life and resulting in energy expenditure. In addition to daily living activities such as playing games, doing housework, walking, eating, and bathing, exercise and sports are also included in this definition. Physical activity is very important for a healthy life. Studies have reported that continuing physical activity, especially during growth and young adulthood, has positive effects on aerobic capacity, blood pressure, body composition, glucose metabolism, skeletal health and psychological health. Studies have reported that physical activity affects social and personal success in healthy adult individuals and is associated with sleep quality and depression. In this context, our work; After regular physical activity, university students who code the course from various faculties and departments within the scope of the university-wide free elective course; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices.
Hypotheses of the study;
- Regular physical activity improves lifelong learning tendencies in university students.
- Regular physical activity increases the level of physical activity in university students.
- Regular physical activity reduces fatigue levels in university students.
- Regular physical activity reduces daytime sleepiness in university students.
- Regular physical activity improves depression, anxiety and stress levels in university students.
- Regular physical activity improves the quality of life in university students.
- Regular physical activity improves functional capacity and increases walking distance in university students.
- Regular physical activity reduces the physiological expenditure index in university students.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be included in an 8-week regular exercise program. Evaluations will be made before and after exercise.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Exercise trainingThis group will get aerobic exercise programme and respiratory exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Students who choose the course offered within the scope of university-wide elective courses
- No obstacle to aerobic exercise
- No chronic disease
- Individuals who have no history of surgery on the lower extremity in the last 6 months
Key exclusion criteria (1 listed)
- Individuals who do not volunteer to participate in the study
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 |
|---|---|---|
| Exercise trainingWithin the physical activity program, an aerobic training program will be applied to students for a total of 150 minutes per week for 8 weeks. Aerobic training includes moderate-intensity walking exercise. The concept of moderate walking will be explained to individuals at the beginning of the study. Maximal and submaximal heart rate calculations will be made with the formulas (220-age) / (220-age X 0.6) and this heart rate will be maintained throughout the training. Students will have a pedometer application installed on their phones and their step counts and exercise minute data will be recorded. At the same time, in order for students to use their respiratory functions properly during regular walking, diaphragmatic breathing and alternating nose breathing breathing exercises will be taught and they will be instructed to do them once a day with 5 repetitions. | Other | Exercise Group |
Primary outcome
Lifelong learning
Time frame: through of the study, average 8 week
Lifelong learning processes will be evaluated with the "Lifelong Learning Tendencies Scale" developed by Coşkun in 2009. The 6-point Likert scale (1 = fits a lot, 6 = doesn't fit at all) consists of 27 items and 4 sub-dimensions. It consists of subheadings: Motivation in Lifelong Learning (6 items), Persistence (6 items), Lack of Regulating Learning (6 items), Lack of Curiosity (9 items). The lowest score that can be obtained from the first three dimensions of the scale is 6 (6x1), the middle score (6x3.5) is 21, and the highest score (6x6) is 36. The last dimension, lack of curiosity, was determined as the lowest score (9x1) 9, the middle score (9x3.5) 31.5 and the highest score (9x9) 81 points. In the overall average of the scale, the minimum score that can be obtained from the scale (27x1) is 27, the median score (27x3.5) is 94.5, and the maximum score (27x6) is 162.
Physical activity
Time frame: through of the study, average 8 week
International Physical Activity Questionnaire-Short Form (IPAQ) will be used to evaluate physical activity. International Physical Activity Survey Short form (7 questions); It provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. The energy required for activities is calculated with the MET-minute score. Standard MET values have been established for these activities. Using these values, daily and weekly physical activity levels are calculated.
Fatique
Time frame: through of the study, average 8 week
Fatigue levels Gencay et al. It will be evaluated with the "Fatigue Severity Scale", the validity and reliability of which was established in 2012. The scale consists of 9 items. The lowest score that can be achieved among the scale items is 0 and the highest score is 7. As the score increases, the severity of fatigue increases.
Daytime sleepiness
Time frame: through of the study, average 8 week
Daytime sleepiness levels of students were developed by John in 1992 and Izci et al. in 2008. It will be evaluated with the "Epworth Sleepiness Scale", whose validity and reliability has been established by. The scale consists of 8 items, the lowest score to be obtained from the scale is 0 and the highest score is 24. As the score increases, the level of daytime sleepiness increases.
Depression, anxiety and stress
Time frame: through of the study, average 8 week
Depression, anxiety and stress levels will be evaluated with the "Depression, anxiety and stress scale". The validity and reliability study of the scale was conducted by Sarıçam in 2018. The scale, consisting of 21 items, is scored between 0-3. As the score increases, depression, anxiety and stress levels increase.
Quality of life measurement
Time frame: through of the study, average 8 week
The quality of life of students was evaluated by Demiral et al. in 2006. It will be evaluated with the "SF-36 Short Form", whose validity and reliability studies have been conducted by. The survey, which consists of 36 items, includes 8 sub-parameters.Scoring is evaluated separately for each sub-dimension. The total score of the scale is not calculated. In the scale, questions 1, 2 and 11 are about general health, questions 3 are about physical functions, question 4 is about physical role limitation, questions 5 are about emotional role limitation, questions 6 and 10 are about social functions, questions 7 and 8 are about pain, questions 9 are about pain. Statements a, e, g and i of the question question vitality, expressions b, c, d, f and h question mental health. Each subscale is scored between 0 and 100. An increase in the dimension mean score indicates that the quality of life is high in that parameter.
Physiological expenditure indices
Time frame: through of the study, average 8 week
The students' resting heart rates and walking heart rates were measured with a pulse oximeter. Physiological expenditure indices will be calculated with the formula = (Heart rate during walking - Resting heart rate) / Walking speed (m/min).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 10795788Sallis JF, Prochaska JJ, Taylor WC. A review of correlates of physical activity of children and adolescents. Med Sci Sports Exerc. 2000 May;32(5):963-75. doi: 10.1097/00005768-200005000-00014.
- Background: PubMed 16534088Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.
- Background: PubMed 22818936Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
- Background: PubMed 19399161Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJ, Ezzati M. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009 Apr 28;6(4):e1000058. doi: 10.1371/journal.pmed.1000058. Epub 2009 Apr 28.
- Background: PubMed 25680021Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71 Suppl 2:114-20. doi: 10.1080/02701367.2000.11082794. No abstract available.
- 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.
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 training in people with Regular Physical Activity and Exercise, run by Hasan Kalyoncu 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuğba GÖNEN, Asst. Prof. (05050905846, tugba.badat@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifelong learning (time frame: through of the study, average 8 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06329115, which also lists 5 linked publications.
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 25 Mar 2024.