Menstrual CycleNCT05697263
The Impact of the Menstrual Cycle on Physical Exercise and Performance
A study testing Periodization of training in people with Menstrual Cycle and Exercise, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Exercise, Women's Health
- What is being tested?
- Periodization of training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2023to Jul 2027
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women exercising at least 3-4 times a week on a high level
- Regular menstrual cycle with 26-32 cycle days.
- Fully healthy and be able to follow the training program.
Who cannot join
- Hormonal contraceptive users,
- Users of regular medication
- Chronic disease
- Past or present neurological disorder
- Recent musculoskeletal injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Angelica Lindén Hirschberg
Stockholm, 17176
Angelica L Hirschberg, Professor, angelica.linden-hirschberg@regionstockholm.se
Cecilia Fridén, Ass Prof, 0046707415122, cecilia.friden@ki.se
About this study
The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups.
The purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise.
Read more
Female athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks):
Group A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase.
Group C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase.
The exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.
- Conditions
- Menstrual Cycle, Exercise, Women's Health, Athletic Performance
- Being tested
- Periodization of training
- Keywords
- Menstrual Cycle, Exercise, Women's Health, Athletic 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.
Periodization of trainingOther
Participants in the three arms will exercise the same dose and number of sessions distributed in three different ways.
| Study group | Role | What they receive |
|---|---|---|
| Follicle phase based training | Experimental | Follicular phase-based training five times a week during the follicular phase (the first two weeks of the menstrual cycle) and thereafter once a week for the rest of the cycle. Receives: Other: Periodization of training |
| Luteal phase based training | Experimental | Luteal phase-based training five times a week during the luteal phase (from ovulation to next menstruation) and once a week in the follicular phase. Receives: Other: Periodization of training |
| Regular training | Experimental | Regular training three times a week throughout the menstrual cycle (control group). Receives: Other: Periodization of training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic performance
Cosmeds K5 Wearable Metabolic System will be used for breath-by-breath gas exchange measurements. Change in VO2peak from baseline to end of study will be evaluated.
Measured: Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)
Secondary outcomes (11)
Change in muscle strength
A standardized isokinetic device (Biodex®, Corp, Shirley, NY, USA) will be used for measurements of maximal muscle torque (Nm) in the leg extensor muscles at 90 and 120 gr/sec (11). Change in muscle strength from baseline to end of study will be compared between groups.
Measured: Change from baseline muscle strength at the end of Cycle 4 (each cycle is around 28 days)
Change in one-leg sit-to-stand test
Assessment of functional muscle strength in the lower extremities.
Measured: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
Change in one-leg hop test for distance
Assessment of functional muscle strength in the lower extremities.
Measured: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
Change in body composition
Differences in body fat (%) will be determined by DXA (Lunar equipment).
Measured: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
Change in body composition
Differences in muscle mass (g), will be determined by DXA (Lunar equipment).
Measured: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
Premenstrual symptoms
Prospective ratings of premenstrual symptoms will be performed with the Cyclicity Diagnoser
Measured: Every day during the study period
Change in metabolic serum markers
Blood samples for analysis of IGF-1.
Measured: Change from baseline metabolic serum markers at the end of Cycle 4 (each cycle is around 28 days)
Change in mucle morphology
Muscle biopsy in mm vastus lateralis
Measured: Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)
Change in muscle tissue steroid hormones
Muscle biopsy in mm vastus lateralis
Measured: Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days)
Change in muscle protein synthesis
Muscle biopsy in mm vastus lateralis
Measured: Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)
Dysmenorrhea
Questionnaire
Measured: Through study completion, an average of 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Aug 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelica Hirschberg Lindén, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697263
- Sponsor's protocol ID
- 2021-01650
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
von Rosen P, Ekenros L, Solli GS, Sandbakk O, Holmberg HC, Hirschberg AL, Friden C. Offered Support and Knowledge about the Menstrual Cycle in the Athletic Community: A Cross-Sectional Study of 1086 Female Athletes. Int J Environ Res Public Health. 2022 Sep 21;19(19):11932. doi: 10.3390/ijerph191911932.
PubMed 36231231Ekenros L, von Rosen P, Solli GS, Sandbakk O, Holmberg HC, Hirschberg AL, Friden C. Perceived impact of the menstrual cycle and hormonal contraceptives on physical exercise and performance in 1,086 athletes from 57 sports. Front Physiol. 2022 Aug 30;13:954760. doi: 10.3389/fphys.2022.954760. eCollection 2022.
PubMed 36111164Ekenros L, Backstrom T, Hirschberg AL, Friden C. Changes in premenstrual symptoms in women starting or discontinuing use of oral contraceptives. Gynecol Endocrinol. 2019 May;35(5):422-426. doi: 10.1080/09513590.2018.1534097. Epub 2019 Jan 22.
PubMed 30668208Von Rosen P, Kottorp A, Friden C, Frohm A, Heijne A. Young, talented and injured: Injury perceptions, experiences and consequences in adolescent elite athletes. Eur J Sport Sci. 2018 Jun;18(5):731-740. doi: 10.1080/17461391.2018.1440009. Epub 2018 Mar 3.
PubMed 29504456von Rosen P, Heijne A, Frohm A, Friden C. Menstrual irregularity and use of oral contraceptives in female adolescent athletes in Swedish National Sports High Schools. Int J Adolesc Med Health. 2017 Nov 23;32(2):/j/ijamh.2020.32.issue-2/ijamh-2017-0113/ijamh-2017-0113.xml. doi: 10.1515/ijamh-2017-0113.
PubMed 29168967Ekenros L, Papoutsi Z, Friden C, Dahlman Wright K, Linden Hirschberg A. Expression of sex steroid hormone receptors in human skeletal muscle during the menstrual cycle. Acta Physiol (Oxf). 2017 Feb;219(2):486-493. doi: 10.1111/apha.12757. Epub 2016 Aug 9.
PubMed 27438889Ekenros L, Hirschberg AL, Heijne A, Friden C. Oral contraceptives do not affect muscle strength and hop performance in active women. Clin J Sport Med. 2013 May;23(3):202-7. doi: 10.1097/JSM.0b013e3182625a51.
PubMed 22948447Ekenros L, Hirschberg AL, Backstrom T, Friden C. Postural control in women with premenstrual symptoms during oral contraceptive treatment. Acta Obstet Gynecol Scand. 2011 Jan;90(1):97-102. doi: 10.1111/j.1600-0412.2010.01021.x. Epub 2010 Nov 26.
PubMed 21275922Friden C, Ramsey DK, Backstrom T, Benoit DL, Saartok T, Linden Hirschberg A. Altered postural control during the luteal phase in women with premenstrual symptoms. Neuroendocrinology. 2005;81(3):150-7. doi: 10.1159/000086592. Epub 2005 Jun 28.
PubMed 15985762Friden C, Hirschberg AL, Saartok T, Renstrom P. Knee joint kinaesthesia and neuromuscular coordination during three phases of the menstrual cycle in moderately active women. Knee Surg Sports Traumatol Arthrosc. 2006 Apr;14(4):383-9. doi: 10.1007/s00167-005-0663-4. Epub 2005 Jun 8.
PubMed 15942744Friden C, Hirschberg AL, Saartok T, Backstrom T, Leanderson J, Renstrom P. The influence of premenstrual symptoms on postural balance and kinesthesia during the menstrual cycle. Gynecol Endocrinol. 2003 Dec;17(6):433-9. doi: 10.1080/09513590312331290358.
PubMed 14992161Friden C, Hirschberg AL, Saartok T. Muscle strength and endurance do not significantly vary across 3 phases of the menstrual cycle in moderately active premenopausal women. Clin J Sport Med. 2003 Jul;13(4):238-41. doi: 10.1097/00042752-200307000-00007.
PubMed 12855926Hirschberg AL. Challenging Aspects of Research on the Influence of the Menstrual Cycle and Oral Contraceptives on Physical Performance. Sports Med. 2022 Jul;52(7):1453-1456. doi: 10.1007/s40279-021-01616-5. Epub 2022 Jan 22. No abstract available.
PubMed 35064914Ekenros L, von Rosen P, Norrbom J, Holmberg HC, Sundberg CJ, Friden C, Hirschberg AL. Impact of Menstrual cycle-based Periodized training on Aerobic performance, a Clinical Trial study protocol-the IMPACT study. Trials. 2024 Jan 29;25(1):93. doi: 10.1186/s13063-024-07921-4.
PubMed 38287424
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Menstrual Cycle on Physical Exercise and Performance
- ClinicalTrials.gov ID
- NCT05697263
- Acronym / sponsor ID
- 2021-01650
- Conditions
- Menstrual Cycle, Exercise, Women's Health, Athletic Performance
- Keywords
- Menstrual Cycle, Exercise, Women's Health, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Jan 2023 (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.
The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups.
The purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise.
Female athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks):
Group A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase.
Group C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase.
The exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Follicle phase based training | Experimental | Other: Periodization of trainingFollicular phase-based training five times a week during the follicular phase (the first two weeks of the menstrual cycle) and thereafter once a week for the rest of the cycle. |
| Luteal phase based training | Experimental | Other: Periodization of trainingLuteal phase-based training five times a week during the luteal phase (from ovulation to next menstruation) and once a week in the follicular phase. |
| Regular training | Experimental | Other: Periodization of trainingRegular training three times a week throughout the menstrual cycle (control group). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women exercising at least 3-4 times a week on a high level
- Regular menstrual cycle with 26-32 cycle days.
- Fully healthy and be able to follow the training program.
Key exclusion criteria (5 listed)
- Hormonal contraceptive users,
- Users of regular medication
- Chronic disease
- Past or present neurological disorder
- Recent musculoskeletal injury
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 |
|---|---|---|
| Periodization of trainingParticipants in the three arms will exercise the same dose and number of sessions distributed in three different ways. | Other | Follicle phase based training, Luteal phase based training, Regular training |
Primary outcome
Change in aerobic performance
Time frame: Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)
Cosmeds K5 Wearable Metabolic System will be used for breath-by-breath gas exchange measurements. Change in VO2peak from baseline to end of study will be evaluated.
11 secondary outcomes
Change in muscle strength
Time frame: Change from baseline muscle strength at the end of Cycle 4 (each cycle is around 28 days)
Change in one-leg sit-to-stand test
Time frame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
Change in one-leg hop test for distance
Time frame: Change from baseline test at the end of Cycle 4 (each cycle is around 28 days)
Change in body composition
Time frame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
Change in body composition
Time frame: Change from baseline body composition at the end of Cycle 4 (each cycle is around 28 days)
Premenstrual symptoms
Time frame: Every day during the study period
Change in metabolic serum markers
Time frame: Change from baseline metabolic serum markers at the end of Cycle 4 (each cycle is around 28 days)
Change in mucle morphology
Time frame: Change from baseline muscle morphology at the end of Cycle 4 (each cycle is around 28 days)
Change in muscle tissue steroid hormones
Time frame: Change from baseline muscle tissue steroid hormones at the end of Cycle 4 (each cycle is around 28 days)
Change in muscle protein synthesis
Time frame: Change from baseline muscle protein synthesis at the end of Cycle 4 (each cycle is around 28 days)
Dysmenorrhea
Time frame: Through study completion, an average of 4 month
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 13 Aug 2026.
- Background: PubMed 36231231von Rosen P, Ekenros L, Solli GS, Sandbakk O, Holmberg HC, Hirschberg AL, Friden C. Offered Support and Knowledge about the Menstrual Cycle in the Athletic Community: A Cross-Sectional Study of 1086 Female Athletes. Int J Environ Res Public Health. 2022 Sep 21;19(19):11932. doi: 10.3390/ijerph191911932.
- Background: PubMed 36111164Ekenros L, von Rosen P, Solli GS, Sandbakk O, Holmberg HC, Hirschberg AL, Friden C. Perceived impact of the menstrual cycle and hormonal contraceptives on physical exercise and performance in 1,086 athletes from 57 sports. Front Physiol. 2022 Aug 30;13:954760. doi: 10.3389/fphys.2022.954760. eCollection 2022.
- Background: PubMed 30668208Ekenros L, Backstrom T, Hirschberg AL, Friden C. Changes in premenstrual symptoms in women starting or discontinuing use of oral contraceptives. Gynecol Endocrinol. 2019 May;35(5):422-426. doi: 10.1080/09513590.2018.1534097. Epub 2019 Jan 22.
- Background: PubMed 29504456Von Rosen P, Kottorp A, Friden C, Frohm A, Heijne A. Young, talented and injured: Injury perceptions, experiences and consequences in adolescent elite athletes. Eur J Sport Sci. 2018 Jun;18(5):731-740. doi: 10.1080/17461391.2018.1440009. Epub 2018 Mar 3.
- Background: PubMed 29168967von Rosen P, Heijne A, Frohm A, Friden C. Menstrual irregularity and use of oral contraceptives in female adolescent athletes in Swedish National Sports High Schools. Int J Adolesc Med Health. 2017 Nov 23;32(2):/j/ijamh.2020.32.issue-2/ijamh-2017-0113/ijamh-2017-0113.xml. doi: 10.1515/ijamh-2017-0113.
- Background: PubMed 27438889Ekenros L, Papoutsi Z, Friden C, Dahlman Wright K, Linden Hirschberg A. Expression of sex steroid hormone receptors in human skeletal muscle during the menstrual cycle. Acta Physiol (Oxf). 2017 Feb;219(2):486-493. doi: 10.1111/apha.12757. Epub 2016 Aug 9.
- Background: PubMed 22948447Ekenros L, Hirschberg AL, Heijne A, Friden C. Oral contraceptives do not affect muscle strength and hop performance in active women. Clin J Sport Med. 2013 May;23(3):202-7. doi: 10.1097/JSM.0b013e3182625a51.
- Background: PubMed 21275922Ekenros L, Hirschberg AL, Backstrom T, Friden C. Postural control in women with premenstrual symptoms during oral contraceptive treatment. Acta Obstet Gynecol Scand. 2011 Jan;90(1):97-102. doi: 10.1111/j.1600-0412.2010.01021.x. Epub 2010 Nov 26.
- Background: PubMed 15985762Friden C, Ramsey DK, Backstrom T, Benoit DL, Saartok T, Linden Hirschberg A. Altered postural control during the luteal phase in women with premenstrual symptoms. Neuroendocrinology. 2005;81(3):150-7. doi: 10.1159/000086592. Epub 2005 Jun 28.
- Background: PubMed 15942744Friden C, Hirschberg AL, Saartok T, Renstrom P. Knee joint kinaesthesia and neuromuscular coordination during three phases of the menstrual cycle in moderately active women. Knee Surg Sports Traumatol Arthrosc. 2006 Apr;14(4):383-9. doi: 10.1007/s00167-005-0663-4. Epub 2005 Jun 8.
- Background: PubMed 14992161Friden C, Hirschberg AL, Saartok T, Backstrom T, Leanderson J, Renstrom P. The influence of premenstrual symptoms on postural balance and kinesthesia during the menstrual cycle. Gynecol Endocrinol. 2003 Dec;17(6):433-9. doi: 10.1080/09513590312331290358.
- Background: PubMed 12855926Friden C, Hirschberg AL, Saartok T. Muscle strength and endurance do not significantly vary across 3 phases of the menstrual cycle in moderately active premenopausal women. Clin J Sport Med. 2003 Jul;13(4):238-41. doi: 10.1097/00042752-200307000-00007.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodization of training in people with Menstrual Cycle and Exercise, run by Karolinska Institutet at 1 site in Sweden.
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 5 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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 Sweden. 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 Angelica L Hirschberg, Med dr (+46702559924, angelica.hirschberg.linden@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aerobic performance (time frame: Change from baseline aerobic performance at the end of Cycle 4 (each cycle is around 28 days)). 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 NCT05697263, which also lists 14 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 13 Aug 2026.