Physical TherapyTRE-SLEEPNCT07234812
Resistance Exercise and Sleep Quality by Chronotype
A study testing Moderate-Intensity Resistance Exercise Program in people with Physical Therapy and Resistance Exercise, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study examines whether doing moderate resistance exercises in the morning can improve sleep quality and well-being in young adults. Participants with different daily activity patterns (morning or evening types) will take part in an 8-week online exercise program. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Therapy, Resistance Exercise, Sleep Disturbances
- What is being tested?
- Moderate-Intensity Resistance Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years
- Generally healthy, with mild to moderate sleep disturbance as categorized by the Pittsburgh Sleep Quality Index (PSQI)
- Body Mass Index (BMI) < 35 kg/m²
- No physical or organic limitations or diseases that would prevent participation in physical activity
- Non-smoker and non-alcoholic
- Caffeine consumption ≤ 2 cups per day (including coffee and energy drinks)
Show all 10Show fewer
- Have not participated in more than 60 minutes/week of usual moderate-to-vigorous physical activity in the past 6 months, categorized as "moderate" on the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
- No clinically diagnosed sleep apnea or other medical/psychiatric disorders responsible for sleep complaints
- Regular sleep schedule (no night shifts or transmeridian travel) in the 30 days prior to study enrollment
- Able to speak and write English
Who cannot join
- Current use of medications or psychotherapeutic drugs for insomnia or other psychiatric disorders
- Use of melatonin or other sleep aids in the past month
- Currently performing any aerobic or mind-body exercise classes (e.g., yoga, Pilates)
- Habitual daytime napping
- History of epilepsy or other convulsive disorders
- Pregnant individuals
- Habitual or recent use (within the past 30 days) of illegal drugs, psychotropic drugs, hypnotics, stimulants, or analgesics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Medipol University
Istanbul, Beykoz/İstanbul, 34810
Aliaa Salem Menshawi, PT, MSc, +905527304660, aliaamenshawi@gmail.com
About this study
Official title: The Effects of Tailored Resistance Exercise on Sleep Quality in Relation to Chronotype
This study examines whether doing moderate resistance exercises in the morning can improve sleep quality and well-being in young adults. Participants with different daily activity patterns (morning or evening types) will take part in an 8-week online exercise program. The study will compare how exercise affects sleep, mood, and daily rhythm across these groups.
Read the detailed description
Disturbed sleep is a widespread issue that affects health, mood, and daily function. Chronotype-the natural tendency to be active earlier or later in the day-may influence how people respond to exercise as a tool for improving sleep.
This trial investigates the effects of an 8-week, moderate-intensity resistance exercise program performed in the morning, delivered through telerehabilitation.
Participants include healthy young adults with self-identified morning or evening chronotypes. The study will measure changes in sleep quality, psychological well-being, alignment of daily rhythms, and will explore whether men and women respond differently to the program..
By comparing outcomes between chronotypes, this research aims to clarify whether exercise benefits are shaped by biological preference for morning or evening activity, or whether improvements occur regardless of chronotype.
The central question is whether improvements occur equally across chronotypes, or if biological preference shapes the response to exercise.
Null Hypothesis (H0): Moderate-intensity morning resistance exercise will have no differential effect on sleep quality, mood, or circadian alignment between participants with morning and evening chronotypes.
Alternative Hypothesis (H1):Moderate-intensity morning resistance exercise will have a differential effect on sleep quality, mood, or circadian alignment between participants with morning and evening chronotypes.
- Conditions
- Physical Therapy, Resistance Exercise, Sleep Disturbances, Sleep Quality, Chronotype, Circadian Rhythm
- Being tested
- Moderate-Intensity Resistance Exercise Program
- Keywords
- sleep disturbance, Sleep quality, Chronotype, Morningness-eveningness, Circadian rhythm, Resistance exercise, Home-based exercise, Sleep and exercise, Physical activity and sleep, Physical Therapy, Exercise, Telerehabilitation, Munich Chronotype Questionnaire (MCTQ), Pittsburgh Sleep Quality Index (PSQI), Mood (BRUMS, DASS-21), Randomized controlled trial, Physical therapy and rehabilitation
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Resistance Exercise ProgramBehavioural
Also called Telerehabilitation Exercise, Resistance Training, Exercise Intervention, Strength Training
An 8-week, moderate-intensity resistance exercise program performed in the morning, 3 sessions/week on nonconsecutive days. Each 45-min session includes: 5-min warm-up (jumping jacks, high knees, running in place, hip hinge with reach, standing twists); 35-min progressive resistance training (Chest Press (Modified Push-Ups), Leg Press (Wall Sits with Squats), Squats, Shoulder Press (Resistance Band Overhead Press), Lat Pulldown (Resistance Band Pull-Downs), Rowing (Resistance Band Rows), Lower Back (Superman Holds), and Abdominals (Plank with Crunches)); and 5-min cool-down (Chest and Shoulder Stretch, Kneeling Hip Flexor Stretch, Standing Hamstring Stretch, Child's Pose with Side Stretch, and Cat-Cow Stretch ). Muscle soreness tracked after each session using 7-point Likert scale. Standardized videos, adherence checklists, resistance bands provided. Both chronotype groups complete identical sessions, outcomes compared.
| Study group | Role | What they receive |
|---|---|---|
| Morning Chronotype - Moderate-Intensity Resistance Exercise | Experimental | Participants identified as morning chronotypes (Munich Chronotype Questionnaire) will complete an 8-week, moderate-intensity resistance exercise program delivered online. Sessions are held in the morning, three times per week, lasting ~45 minutes (5-min warm-up, 35-min resistance training, 5-min cool-down). Exercises include push-ups, wall sits, squats, resistance band presses and pulls, rows, superman holds, and planks. Intensity is guided by 1RM testing, perceived exertion scales, and 7 point Likert scale of muscle soreness. Receives: Behavioral: Moderate-Intensity Resistance Exercise Program |
| Evening Chronotype - Moderate-Intensity Resistance Exercise | Experimental | Participants identified as evening chronotypes (Munich Chronotype Questionnaire) will complete an 8-week, moderate-intensity resistance exercise program delivered online. Sessions are held in the morning, three times per week, lasting ~45 minutes (5-min warm-up, 35-min resistance training, 5-min cool-down). Exercises include push-ups, wall sits, squats, resistance band presses and pulls, rows, superman holds, and planks. Intensity is guided by 1RM testing, perceived exertion scales, and 7 point Likert scale of muscle soreness. Receives: Behavioral: Moderate-Intensity Resistance Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire that evaluates sleep patterns over the past month. The PSQI generates seven component scores (subjective sleep quality, latency, duration, efficiency, disturbances, use of medication, daytime dysfunction), which are summed into a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. Assessments will be conducted at baseline (week 0), midpoint (week 4), and end of study (week 8). The primary endpoint is the change in global PSQI score from baseline to week 8, comparing differences between morning and evening chronotype groups following the resistance exercise program.
Measured: Baseline, Week 4, and Week 8; primary comparison is change from baseline to Week 8
Secondary outcomes (7)
Change in Circadian Alignment Assessed by Munich Chronotype Questionnaire (MCTQ)
Chronotype and social jetlag will be evaluated using the MCTQ. The endpoint is change in chronotype alignment from baseline to week 8 and its relationship to exercise outcomes.
Measured: Baseline and Week 8
Change in Mood Assessed by Brunel Mood Scale (BRUMS)
The Brunel Mood Scale (BRUMS) measures six mood states: anger, confusion, depression, fatigue, tension, and vigor. Higher scores reflect greater mood disturbance. Outcomes will track changes in mood from baseline to follow-up. It is a five-point Likert scale ranging from 0 (not at all) to 4 (extremely) according to their current feelings. The mood score is computed as the sum of all 24 items, with higher scores reflecting a greater intensity of that particular mood
Measured: Baseline, Week 4, and Week 8
Perceived Effort Assessed by OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES)
The OMNI-RES is a 0-10 rating scale used to assess perceived exertion during resistance training. Higher scores reflect greater perceived effort. Participants will rate their exertion after each exercise session.
Measured: Throughout Weeks 1-8
Muscle Soreness Assessed by 7-Point Likert Scale
Participants will rate post-exercise soreness from 0 (no soreness) to 6 (severe soreness limiting movement) after each session to monitor tolerance.
Measured: After each exercise session, Weeks 1-8
Change in Physical Activity Level Assessed by International Physical Activity Questionnaire-Short Form (IPAQ-SF)
The IPAQ-SF will measure weekly physical activity (MET-min/week and sedentary time). Outcomes include classification into low, moderate, or high activity.
Measured: Baseline and Week 8
Change in Mood Assessed by Depression Anxiety Stress Scales-21 (DASS-21)
The DASS-21 is a 21-item questionnaire that evaluates symptoms of depression, anxiety, and stress. Higher scores indicate more severe symptoms. Outcomes will capture changes in psychological well-being across the intervention period. it is using a 4-point (0-3) Likert-type scale (ranging from "did not apply to me at all" 0, to "applied to me very much or most of the time" 3). Higher scores indicate greater severity of depression, anxiety, and stress symptoms, with subscale scores ranging from 0 to 42 and total scores from 0 to 126.
Measured: Baseline, Week 4, and Week 8
Change in Muscle Strength Assessed by One-Repetition Maximum (1RM)
Muscle strength will be measured using the one-repetition maximum (1RM) test for selected resistance exercises. The primary outcome is change in maximal strength over the intervention period.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Physical TherapyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups based on chronotype classification (morning type or evening type). Both groups will complete the same 8-week, moderate-intensity resistance exercise program delivered via online sessions three times per week in the morning. Outcomes will be compared between the two chronotype groups to evaluate whether the effects of exercise on sleep quality and mood differ by chronotype.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Salem Mohamed Mohamed Menshawi, Medipol University
- Investigators
- Gizem Ergezen Şahin, Dr. Assistant Professor, Study director, Department of Physiotherapy and Rehabilitation/Istanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234812
- Sponsor's protocol ID
- E-10840098-202.3.02-1592
- Acronym
- TRE-SLEEP
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheville AL, Kollasch J, Vandenberg J, Shen T, Grothey A, Gamble G, Basford JR. A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):811-21. doi: 10.1016/j.jpainsymman.2012.05.006. Epub 2012 Sep 24.
PubMed 23017624Karandikar-Agashe G, Agrawal R. Comparative Study of the Effect of Resistance Exercises versus Aerobic Exercises in Postmenopausal Women Suffering from Insomnia. J Midlife Health. 2020 Jan-Mar;11(1):2-5. doi: 10.4103/jmh.JMH_35_19. Epub 2020 May 4.
PubMed 32684719Passos GS, Poyares D, Santana MG, Garbuio SA, Tufik S, Mello MT. Effect of acute physical exercise on patients with chronic primary insomnia. J Clin Sleep Med. 2010 Jun 15;6(3):270-5.
PubMed 20572421de Sa Souza H, de Melo CM, Piovezan RD, Miranda REEPC, Carneiro-Junior MA, Silva BM, Thomatieli-Santos RV, Tufik S, Poyares D, D'Almeida V. Resistance Training Improves Sleep and Anti-Inflammatory Parameters in Sarcopenic Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Dec 6;19(23):16322. doi: 10.3390/ijerph192316322.
PubMed 36498393Maric D, Ficarra S, Di Bartolo L, Rossi C, Asimakopoulou Z, Vantarakis A, Carbonell-Baeza A, Jimenez-Pavon D, Gomes B, Tavares P, Baxter R, Pusa S, Thaller P, Papakonstantinou S, Kirkar M, Glorioso F, Galioto M, Gentile A, Thomas E, Bianco A. Effects of resistance training on sleep quality and disorders among individuals diagnosed with cancer: A systematic review and meta-analysis of randomized controlled trials. Cancer Med. 2024 Apr;13(8):e7179. doi: 10.1002/cam4.7179.
PubMed 38650577Vickers AJ. Time course of muscle soreness following different types of exercise. BMC Musculoskelet Disord. 2001;2:5. doi: 10.1186/1471-2474-2-5. Epub 2001 Oct 23.
PubMed 11701094Morishita S, Tsubaki A, Takabayashi T, Fu JB. Relationship between the rating of perceived exertion scale and the load intensity of resistance training. Strength Cond J. 2018 Apr;40(2):94-109. doi: 10.1519/SSC.0000000000000373.
PubMed 29674945Robertson RJ, Goss FL, Rutkowski J, Lenz B, Dixon C, Timmer J, Frazee K, Dube J, Andreacci J. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sports Exerc. 2003 Feb;35(2):333-41. doi: 10.1249/01.MSS.0000048831.15016.2A.
PubMed 12569225Terry PC, Lane AM, Lane HJ, Keohane L. Development and validation of a mood measure for adolescents. J Sports Sci. 1999 Nov;17(11):861-72. doi: 10.1080/026404199365425.
PubMed 10585166Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
PubMed 22294820Seo DI, Kim E, Fahs CA, Rossow L, Young K, Ferguson SL, Thiebaud R, Sherk VD, Loenneke JP, Kim D, Lee MK, Choi KH, Bemben DA, Bemben MG, So WY. Reliability of the one-repetition maximum test based on muscle group and gender. J Sports Sci Med. 2012 Jun 1;11(2):221-5. eCollection 2012.
PubMed 24149193Sjostrom, M., Ainsworth, B.E., Bauman, A., Bull, F.C., Hamilton-Craig, C.R., & Sallis, J.F. (2005). Guidelines for data processing analysis of the International Physical Activity Questionnaire (IPAQ) - Short and long forms.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Zavada A, Gordijn MC, Beersma DG, Daan S, Roenneberg T. Comparison of the Munich Chronotype Questionnaire with the Horne-Ostberg's Morningness-Eveningness Score. Chronobiol Int. 2005;22(2):267-78. doi: 10.1081/cbi-200053536.
PubMed 16021843Kantermann T, Sung H, Burgess HJ. Comparing the Morningness-Eveningness Questionnaire and Munich ChronoType Questionnaire to the Dim Light Melatonin Onset. J Biol Rhythms. 2015 Oct;30(5):449-53. doi: 10.1177/0748730415597520. Epub 2015 Aug 4.
PubMed 26243627
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tailored Resistance Exercise on Sleep Quality in Relation to Chronotype
- ClinicalTrials.gov ID
- NCT07234812
- Acronym / sponsor ID
- TRE-SLEEP / E-10840098-202.3.02-1592
- Conditions
- Physical Therapy, Resistance Exercise, Sleep Disturbances, Sleep Quality, Chronotype, Circadian Rhythm
- Keywords
- sleep disturbance, Sleep quality, Chronotype, Morningness-eveningness, Circadian rhythm, Resistance exercise, Home-based exercise, Sleep and exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Nov 2025 (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.
This study examines whether doing moderate resistance exercises in the morning can improve sleep quality and well-being in young adults. Participants with different daily activity patterns (morning or evening types) will take part in an 8-week online exercise program. The study will compare how exercise affects sleep, mood, and daily rhythm across these groups.
Detailed description
Disturbed sleep is a widespread issue that affects health, mood, and daily function. Chronotype-the natural tendency to be active earlier or later in the day-may influence how people respond to exercise as a tool for improving sleep.
This trial investigates the effects of an 8-week, moderate-intensity resistance exercise program performed in the morning, delivered through telerehabilitation.
Participants include healthy young adults with self-identified morning or evening chronotypes. The study will measure changes in sleep quality, psychological well-being, alignment of daily rhythms, and will explore whether men and women respond differently to the program..
By comparing outcomes between chronotypes, this research aims to clarify whether exercise benefits are shaped by biological preference for morning or evening activity, or whether improvements occur regardless of chronotype.
The central question is whether improvements occur equally across chronotypes, or if biological preference shapes the response to exercise.
Null Hypothesis (H0): Moderate-intensity morning resistance exercise will have no differential effect on sleep quality, mood, or circadian alignment between participants with morning and evening chronotypes.
Alternative Hypothesis (H1):Moderate-intensity morning resistance exercise will have a differential effect on sleep quality, mood, or circadian alignment between participants with morning and evening chronotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups based on chronotype classification (morning type or evening type). Both groups will complete the same 8-week, moderate-intensity resistance exercise program delivered via online sessions three times per week in the morning. Outcomes will be compared between the two chronotype groups to evaluate whether the effects of exercise on sleep quality and mood differ by chronotype.
| Arm | Type | Receives |
|---|---|---|
| Morning Chronotype - Moderate-Intensity Resistance Exercise | Experimental | Behavioral: Moderate-Intensity Resistance Exercise ProgramParticipants identified as morning chronotypes (Munich Chronotype Questionnaire) will complete an 8-week, moderate-intensity resistance exercise program delivered online. Sessions are held in the morning, three times per week, lasting ~45 minutes (5-min warm-up, 35-min resistance training, 5-min cool-down). Exercises include push-ups, wall sits, squats, resistance band presses and pulls, rows, superman holds, and planks. Intensity is guided by 1RM testing, perceived exertion scales, and 7 point Likert scale of muscle soreness. |
| Evening Chronotype - Moderate-Intensity Resistance Exercise | Experimental | Behavioral: Moderate-Intensity Resistance Exercise ProgramParticipants identified as evening chronotypes (Munich Chronotype Questionnaire) will complete an 8-week, moderate-intensity resistance exercise program delivered online. Sessions are held in the morning, three times per week, lasting ~45 minutes (5-min warm-up, 35-min resistance training, 5-min cool-down). Exercises include push-ups, wall sits, squats, resistance band presses and pulls, rows, superman holds, and planks. Intensity is guided by 1RM testing, perceived exertion scales, and 7 point Likert scale of muscle soreness. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18 and 35 years
- Generally healthy, with mild to moderate sleep disturbance as categorized by the Pittsburgh Sleep Quality Index (PSQI)
- Body Mass Index (BMI) < 35 kg/m²
- No physical or organic limitations or diseases that would prevent participation in physical activity
- Non-smoker and non-alcoholic
Key exclusion criteria (7 listed)
- Current use of medications or psychotherapeutic drugs for insomnia or other psychiatric disorders
- Use of melatonin or other sleep aids in the past month
- Currently performing any aerobic or mind-body exercise classes (e.g., yoga, Pilates)
- Habitual daytime napping
- History of epilepsy or other convulsive disorders
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 |
|---|---|---|
| Moderate-Intensity Resistance Exercise ProgramAlso: Telerehabilitation Exercise, Resistance Training, Exercise Intervention, Strength TrainingAn 8-week, moderate-intensity resistance exercise program performed in the morning, 3 sessions/week on nonconsecutive days. Each 45-min session includes: 5-min warm-up (jumping jacks, high knees, running in place, hip hinge with reach, standing twists); 35-min progressive resistance training (Chest Press (Modified Push-Ups), Leg Press (Wall Sits with Squats), Squats, Shoulder Press (Resistance Band Overhead Press), Lat Pulldown (Resistance Band Pull-Downs), Rowing (Resistance Band Rows), Lower Back (Superman Holds), and Abdominals (Plank with Crunches)); and 5-min cool-down (Chest and Shoulder Stretch, Kneeling Hip Flexor Stretch, Standing Hamstring Stretch, Child's Pose with Side Stretch, and Cat-Cow Stretch ). Muscle soreness tracked after each session using 7-point Likert scale. Standardized videos, adherence checklists, resistance bands provided. Both chronotype groups complete identical sessions, outcomes compared. | Behavioural | Evening Chronotype - Moderate-Intensity Resistance Exercise, Morning Chronotype - Moderate-Intensity Resistance Exercise |
Primary outcome
Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 4, and Week 8; primary comparison is change from baseline to Week 8
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire that evaluates sleep patterns over the past month. The PSQI generates seven component scores (subjective sleep quality, latency, duration, efficiency, disturbances, use of medication, daytime dysfunction), which are summed into a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. Assessments will be conducted at baseline (week 0), midpoint (week 4), and end of study (week 8). The primary endpoint is the change in global PSQI score from baseline to week 8, comparing differences between morning and evening chronotype groups following the resistance exercise program.
7 secondary outcomes
Change in Circadian Alignment Assessed by Munich Chronotype Questionnaire (MCTQ)
Time frame: Baseline and Week 8
Change in Mood Assessed by Brunel Mood Scale (BRUMS)
Time frame: Baseline, Week 4, and Week 8
Perceived Effort Assessed by OMNI Perceived Exertion Scale for Resistance Exercise (OMNI-RES)
Time frame: Throughout Weeks 1-8
Muscle Soreness Assessed by 7-Point Likert Scale
Time frame: After each exercise session, Weeks 1-8
Change in Physical Activity Level Assessed by International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: Baseline and Week 8
Change in Mood Assessed by Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Baseline, Week 4, and Week 8
Change in Muscle Strength Assessed by One-Repetition Maximum (1RM)
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 23017624Cheville AL, Kollasch J, Vandenberg J, Shen T, Grothey A, Gamble G, Basford JR. A home-based exercise program to improve function, fatigue, and sleep quality in patients with Stage IV lung and colorectal cancer: a randomized controlled trial. J Pain Symptom Manage. 2013 May;45(5):811-21. doi: 10.1016/j.jpainsymman.2012.05.006. Epub 2012 Sep 24.
- Background: PubMed 32684719Karandikar-Agashe G, Agrawal R. Comparative Study of the Effect of Resistance Exercises versus Aerobic Exercises in Postmenopausal Women Suffering from Insomnia. J Midlife Health. 2020 Jan-Mar;11(1):2-5. doi: 10.4103/jmh.JMH_35_19. Epub 2020 May 4.
- Background: PubMed 20572421Passos GS, Poyares D, Santana MG, Garbuio SA, Tufik S, Mello MT. Effect of acute physical exercise on patients with chronic primary insomnia. J Clin Sleep Med. 2010 Jun 15;6(3):270-5.
- Background: PubMed 36498393de Sa Souza H, de Melo CM, Piovezan RD, Miranda REEPC, Carneiro-Junior MA, Silva BM, Thomatieli-Santos RV, Tufik S, Poyares D, D'Almeida V. Resistance Training Improves Sleep and Anti-Inflammatory Parameters in Sarcopenic Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Dec 6;19(23):16322. doi: 10.3390/ijerph192316322.
- Background: PubMed 38650577Maric D, Ficarra S, Di Bartolo L, Rossi C, Asimakopoulou Z, Vantarakis A, Carbonell-Baeza A, Jimenez-Pavon D, Gomes B, Tavares P, Baxter R, Pusa S, Thaller P, Papakonstantinou S, Kirkar M, Glorioso F, Galioto M, Gentile A, Thomas E, Bianco A. Effects of resistance training on sleep quality and disorders among individuals diagnosed with cancer: A systematic review and meta-analysis of randomized controlled trials. Cancer Med. 2024 Apr;13(8):e7179. doi: 10.1002/cam4.7179.
- Background: PubMed 11701094Vickers AJ. Time course of muscle soreness following different types of exercise. BMC Musculoskelet Disord. 2001;2:5. doi: 10.1186/1471-2474-2-5. Epub 2001 Oct 23.
- Background: PubMed 29674945Morishita S, Tsubaki A, Takabayashi T, Fu JB. Relationship between the rating of perceived exertion scale and the load intensity of resistance training. Strength Cond J. 2018 Apr;40(2):94-109. doi: 10.1519/SSC.0000000000000373.
- Background: PubMed 12569225Robertson RJ, Goss FL, Rutkowski J, Lenz B, Dixon C, Timmer J, Frazee K, Dube J, Andreacci J. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sports Exerc. 2003 Feb;35(2):333-41. doi: 10.1249/01.MSS.0000048831.15016.2A.
- Background: PubMed 10585166Terry PC, Lane AM, Lane HJ, Keohane L. Development and validation of a mood measure for adolescents. J Sports Sci. 1999 Nov;17(11):861-72. doi: 10.1080/026404199365425.
- Background: PubMed 22294820Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
- Background: PubMed 24149193Seo DI, Kim E, Fahs CA, Rossow L, Young K, Ferguson SL, Thiebaud R, Sherk VD, Loenneke JP, Kim D, Lee MK, Choi KH, Bemben DA, Bemben MG, So WY. Reliability of the one-repetition maximum test based on muscle group and gender. J Sports Sci Med. 2012 Jun 1;11(2):221-5. eCollection 2012.
- BackgroundSjostrom, M., Ainsworth, B.E., Bauman, A., Bull, F.C., Hamilton-Craig, C.R., & Sallis, J.F. (2005). Guidelines for data processing analysis of the International Physical Activity Questionnaire (IPAQ) - Short and long forms.
- National Sleep Foundation's sleep time duration recommendations: methodology and results summaryLink provided by the sponsor.
- Effects of resistance exercise training and stretching on chronic insomniaLink provided by the sponsor.
- Resistance training improves sleep quality, redox balance and inflammatory profile in maintenance hemodialysis patients: a randomized controlled trial.Link provided by the sponsor.
- 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.
Gizem Ergezen Şahin, Dr. Assistant Professor study director
Department of Physiotherapy and Rehabilitation/Istanbul Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Resistance Exercise Program in people with Physical Therapy and Resistance Exercise, run by Medipol 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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliaa Salem Menshawi, PT, MSc (Cand.) (+905527304660 ext. +96550268508, aliaamenshawi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline, Week 4, and Week 8; primary comparison is change from baseline to Week 8). 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 NCT07234812, which also lists 20 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 20 Nov 2025.