NCT06329115

Brief 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 levels, quality of life and walking distances and physiological expenditure indices.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 18, 2024

Last Update Submit

March 18, 2024

Conditions

Keywords

Physical acitivityDepressionAnxietySleep qualityHealth life learningQuality of lifeFunctional capasityphysiological expenditure

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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).

    through of the study, average 8 week

Study Arms (1)

Exercise Group

EXPERIMENTAL

This group will get aerobic exercise programme and respiratory exercise

Other: Exercise training

Interventions

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.

Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Individuals who do not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 10795788BACKGROUND
  • Warburton 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.

    PMID: 16534088BACKGROUND
  • Lee 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.

    PMID: 22818936BACKGROUND
  • Danaei 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.

    PMID: 19399161BACKGROUND
  • Booth 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.

    PMID: 25680021BACKGROUND

MeSH Terms

Conditions

Motor ActivityDepressionAnxiety DisordersSleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tuğba GÖNEN, Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants will be included in an 8-week regular exercise program. Evaluations will be made before and after exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

March 25, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations