NCT06311539

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 7, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

circadian rhythmchronotypephysical performance

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    T0 and T1 (Baseline and after 6 week exercise program)

Study Arms (2)

Morning chronotype

EXPERIMENTAL

Participants who score between 59-70 in the Morningness Eveningness Questionnaire will be assigned to the morning chronotype group.

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.

Other: Theraband Strengthening Exercise Program

Interventions

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).

Evening chronotypeMorning chronotype

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale participants will be included in the research.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being male,
  • Between the ages of 18-30
  • Having a chronotype that was morning person or evening person in the Morningness-Eveningness Questionnaire

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ilksan Demirbuken, PhD

    Marmara University, Faculty of Health Sciences

    STUDY DIRECTOR
  • Ender Ersin Avci, PhD

    Marmara University, Faculty of Health Sciences

    STUDY DIRECTOR
  • Mine Gulden Polat, PhD

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

Furkan Cakir, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluator who will perform isokinetic assessments and vertical jump measurements will be blinded to the participants' chronotype.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 15, 2024

Study Start

April 1, 2024

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share