ChronotypeNCT06311539
The Effect of Circadian Rhythm on Physical Performance in Healthy Male Individuals
A study testing Theraband Strengthening Exercise Program in people with Chronotype and Exercise, run by Istanbul Bilgi University.
Trial summary
Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronotype, Exercise
- What is being tested?
- Theraband Strengthening Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Oct 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 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being male,
- Between the ages of 18-30
- Having a chronotype that was morning person or evening person in the Morningness-Eveningness Questionnaire
Who cannot join
- Being female
- Having an intermediate chronotype in the Morningness-Eveningness Questionnaire
- Having a history of surgery or limitation in the knee area
- Having a metabolic, neurological, or orthopedic disorder.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Chronotype and Circadian Rhythm on Physical Performance in Healthy Male Individuals
Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Circadian rhythms can be observed in behavior, physiology, and metabolism. Various studies show that exercise changes the rhythm of the clock machines in skeletal muscle. Studies examining the relationship between exercise, especially strength training, and circadian rhythm are quite limited in the literature. Although some studies have shown that force peaks in the afternoon/evening hours, regardless of muscle group and contraction speed, there are no studies on how much this time interval varies from person to person and chronotype.
The aim of this study is to investigate to what extent strength training given at appropriate times for morning, evening and intermediate chronotypes creates changes in performance in healthy adult male individuals.
Read the detailed description
After participants are informed about the research, evaluation and exercise protocol, their signed consent will be obtained.
The Morningness-Eveningness Questionnaire will be applied until 30 participants with morning type and 30 evening type chronotypes are reached. (Estimated for 100 students) After determining 30 morning type and 30 evening type participants, isokinetic evaluations will be made and vertical jump heights will be measured (T0).
Then, 15 morning type participants will be included in the morning exercise program (08:00) and 15 morning type participants will be included in the evening exercise program (18:00).
15 evening type participants will be included in the morning exercise program (08:00) and 15 evening type participants will be included in the evening exercise program (18:00).
Thus, some of the participants from both morning and evening groups will be included in strength training for 6 weeks, at a time appropriate to their chronotypes, and some at a time incompatible with their chronotypes. Isokinetic evaluations and vertical jump height measurements will be repeated at the end of the strengthening exercise program, which will last 3 days a week for 6 weeks, a total of 18 sessions.
- Conditions
- Chronotype, Exercise
- Being tested
- Theraband Strengthening Exercise Program
- Keywords
- circadian rhythm, chronotype, physical performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraband Strengthening Exercise ProgramOther
Resisted knee flexion in prone position and resisted knee extension in seated position (for dominant leg) and bilateral squats were practiced in 3 sets of 12 repetitions. Participants rested for 30 seconds between sets. The program, which lasted approximately 30 minutes in total, continued for a total of 6 weeks, the first 3 weeks with the red theraband and the last 3 weeks with the black theraband.
15 morning type participants will be included in the morning exercise program (08:00) and 15 morning type participants will be included in the evening exercise program (18:00).
15 evening type participants will be included in the morning exercise program (08:00) and 15 evening type participants will be included in the evening exercise program (18:00).
| Study group | Role | What they receive |
|---|---|---|
| Morning chronotype | Experimental | Participants who score between 59-70 in the Morningness Eveningness Questionnaire will be assigned to the morning chronotype group. Receives: Other: Theraband Strengthening Exercise Program |
| Evening chronotype | Experimental | Participants who score between 16-41 in the Morningness Eveningness Questionnaire will be assigned to the evening chronotype group. Receives: Other: Theraband Strengthening Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic strength test
Isokinetic evaluations will be made with the 'Biodex® System3 Isokinetic (Biodex Medical Systems, Inc, New York, New York, USA)' brand isokinetic dynamometer. The study will be performed on the dominant side lower extremity knee flexor and extensor muscle groups. Individuals' isokinetic quadriceps and hamstring muscle strengths will be evaluated at different angular velocities (60°/sec and 180°/sec). Quadriceps and hamstring muscle strengths will be evaluated with a protocol consisting of 5 repetitions of 60°/sec flexion-extension concentric-concentric movement, and 1 set of 10 repetitions of 180°/sec flexion-extension concentric-concentric movement. There will be 1-minute rest breaks between sets. Maximum voluntary contraction, peak torque and peak torque/body weight values will be recorded.
Measured: T0 and T1 (Baseline and after 6 week exercise program)
Vertical jump test
For vertical jump height measurement, participants were asked to stand next to the wall on the dominant foot to be evaluated (jumping leg). The participant touched the wall, which was graded in centimeters, with one hand. The participant was asked to jump with all his strength and touch the highest point he could touch. The height of the jump made by the participant with the dominant foot was measured by recording the height of the vertical tip of the hand in the starting position and the test height. This test was repeated three times, with a 60-second rest interval between each jump. The best value obtained was recorded in centimeters (cm).
Measured: T0 and T1 (Baseline and after 6 week exercise program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChronotypeStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Çakır, Istanbul Bilgi University
- Investigators
- Ilksan Demirbuken, PhD, Study director, Marmara University, Faculty of Health SciencesEnder Ersin Avci, PhD, Study director, Marmara University, Faculty of Health SciencesMine Gulden Polat, PhD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311539
- Sponsor's protocol ID
- IstanbulBUFC4
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronotype and Circadian Rhythm on Physical Performance in Healthy Male Individuals
- ClinicalTrials.gov ID
- NCT06311539
- Acronym / sponsor ID
- IstanbulBUFC4
- Conditions
- Chronotype, Exercise
- Keywords
- circadian rhythm, chronotype, physical performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 15 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.
Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Circadian rhythms can be observed in behavior, physiology, and metabolism. Various studies show that exercise changes the rhythm of the clock machines in skeletal muscle. Studies examining the relationship between exercise, especially strength training, and circadian rhythm are quite limited in the literature. Although some studies have shown that force peaks in the afternoon/evening hours, regardless of muscle group and contraction speed, there are no studies on how much this time interval varies from person to person and chronotype.
The aim of this study is to investigate to what extent strength training given at appropriate times for morning, evening and intermediate chronotypes creates changes in performance in healthy adult male individuals.
Detailed description
After participants are informed about the research, evaluation and exercise protocol, their signed consent will be obtained.
The Morningness-Eveningness Questionnaire will be applied until 30 participants with morning type and 30 evening type chronotypes are reached. (Estimated for 100 students) After determining 30 morning type and 30 evening type participants, isokinetic evaluations will be made and vertical jump heights will be measured (T0).
Then, 15 morning type participants will be included in the morning exercise program (08:00) and 15 morning type participants will be included in the evening exercise program (18:00).
15 evening type participants will be included in the morning exercise program (08:00) and 15 evening type participants will be included in the evening exercise program (18:00).
Thus, some of the participants from both morning and evening groups will be included in strength training for 6 weeks, at a time appropriate to their chronotypes, and some at a time incompatible with their chronotypes. Isokinetic evaluations and vertical jump height measurements will be repeated at the end of the strengthening exercise program, which will last 3 days a week for 6 weeks, a total of 18 sessions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Morning chronotype | Experimental | Other: Theraband Strengthening Exercise ProgramParticipants who score between 59-70 in the Morningness Eveningness Questionnaire will be assigned to the morning chronotype group. |
| Evening chronotype | Experimental | Other: Theraband Strengthening Exercise ProgramParticipants who score between 16-41 in the Morningness Eveningness Questionnaire will be assigned to the evening chronotype group. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being male,
- Between the ages of 18-30
- Having a chronotype that was morning person or evening person in the Morningness-Eveningness Questionnaire
Key exclusion criteria (4 listed)
- Being female
- Having an intermediate chronotype in the Morningness-Eveningness Questionnaire
- Having a history of surgery or limitation in the knee area
- Having a metabolic, neurological, or orthopedic disorder.
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 |
|---|---|---|
| Theraband Strengthening Exercise ProgramResisted knee flexion in prone position and resisted knee extension in seated position (for dominant leg) and bilateral squats were practiced in 3 sets of 12 repetitions. Participants rested for 30 seconds between sets. The program, which lasted approximately 30 minutes in total, continued for a total of 6 weeks, the first 3 weeks with the red theraband and the last 3 weeks with the black theraband. 15 morning type participants will be included in the morning exercise program (08:00) and 15 morning type participants will be included in the evening exercise program (18:00). 15 evening type participants will be included in the morning exercise program (08:00) and 15 evening type participants will be included in the evening exercise program (18:00). | Other | Evening chronotype, Morning chronotype |
Primary outcome
Isokinetic strength test
Time frame: T0 and T1 (Baseline and after 6 week exercise program)
Isokinetic evaluations will be made with the 'Biodex® System3 Isokinetic (Biodex Medical Systems, Inc, New York, New York, USA)' brand isokinetic dynamometer. The study will be performed on the dominant side lower extremity knee flexor and extensor muscle groups. Individuals' isokinetic quadriceps and hamstring muscle strengths will be evaluated at different angular velocities (60°/sec and 180°/sec). Quadriceps and hamstring muscle strengths will be evaluated with a protocol consisting of 5 repetitions of 60°/sec flexion-extension concentric-concentric movement, and 1 set of 10 repetitions of 180°/sec flexion-extension concentric-concentric movement. There will be 1-minute rest breaks between sets. Maximum voluntary contraction, peak torque and peak torque/body weight values will be recorded.
Vertical jump test
Time frame: T0 and T1 (Baseline and after 6 week exercise program)
For vertical jump height measurement, participants were asked to stand next to the wall on the dominant foot to be evaluated (jumping leg). The participant touched the wall, which was graded in centimeters, with one hand. The participant was asked to jump with all his strength and touch the highest point he could touch. The height of the jump made by the participant with the dominant foot was measured by recording the height of the vertical tip of the hand in the starting position and the test height. This test was repeated three times, with a 60-second rest interval between each jump. The best value obtained was recorded in centimeters (cm).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
Ilksan Demirbuken, PhD study director
Marmara University, Faculty of Health Sciences
Ender Ersin Avci, PhD study director
Marmara University, Faculty of Health Sciences
Mine Gulden Polat, PhD study director
Marmara University
Questions about this trial
What is this clinical trial studying?
A study testing Theraband Strengthening Exercise Program in people with Chronotype and Exercise, run by Istanbul Bilgi University.
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 3 inclusion and 4 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Furkan Cakir, MSc (5426033944 ext. +90, fztfurkancakir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic strength test (time frame: T0 and T1 (Baseline and after 6 week exercise program)). 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 15 Mar 2024.