Breast Cancer SurvivorsMUSCLE-CLIMNCT05690295
Resistance-type Exercise Training in Postmenopausal Women Survivors of Breast Cancer
A study testing Prolonged resistance-type exercise training in people with Breast Cancer Survivors and Postmenopause, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
Background: In postmenopausal women, an alteration in body composition occurs as a consequence of the secretion of low levels of serum estrogens by the ovaries. Observing an increase in abdominal and mammary fat mass and a decrease in skeletal muscle mass, which is also accompanied by loss of muscle strength and… Read more about this study
- Who is it for?
- Ages 45 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors, Postmenopause, Resistance Training
- What is being tested?
- Prolonged resistance-type exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChile
- Study dates
- 22 Mar 2023to 15 May 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 45 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy postmenopausal women and postmenopausal women survivors of breast cancer with and without Hormonal Therapy (Aromatase Inhibitors and Tamoxifen) between 45 to 59 years.
- Women survivors of breast cancer with active Hormone Therapy in the last 12 months.
- Women breast cancer survivors with luminal molecular profile and positive estrogen receptors.
- Body mass index 18.5 < BMI < 30 kg/m2.
- Volunteers without cognitive impairment (abbreviated Minimental >13 points).
Who cannot join
- Active antineoplastic treatment in the last 12 months.
- >200 mL of volume difference between upper limbs and/or stage IV breast cancer.
- Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
- Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
- All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise training (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).
Trial locations and contacts
1 site in 1 country.
Chile1 site
Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile
Temuco
About this study
Official title: Comparison of the Effects of Prolonged Resistance-type Exercise Training Between Healthy Postmenopausal Women Versus Postmenopausal Women Survivors of Breast Cancer
Background: In postmenopausal women, an alteration in body composition occurs as a consequence of the secretion of low levels of serum estrogens by the ovaries. Observing an increase in abdominal and mammary fat mass and a decrease in skeletal muscle mass, which is also accompanied by loss of muscle strength and physical function, which leads early to a sarcopenia.
On the other hand, the increase in estrogen production by adipose tissue has been associated with an increased risk of breast cancer during menopause because the mammary parenchyma is particularly sensitive to this type of estrogen. For this reason, Hormone Therapy (Aromatase Inhibitors and Tamoxifen) is prescribed in women with estrogen receptor-positive breast cancer. Antineoplastic treatments (Chemotherapy and Hormonal Therapy) have contributed to non-metastatic breast cancer currently presenting a high survival rate, not without adverse effects associated with the course of the disease, age and antineoplastic treatment, affecting various systems, but particularly skeletal muscle mass.
Therefore, resistance exercise training has been proposed as an effective intervention strategy to increase muscle mass and strength in different populations. However, the level of muscle response to this type of training in postmenopausal women survivors of breast cancer with and without hormone treatment (Aromatase Inhibitors and Tamoxifen) is unknown.
Read the detailed description
Hypothesis: The increase in skeletal muscle mass after 12 weeks of progressive resistance-type exercise training is less in postmenopausal breast cancer survivors compared to healthy women of the same age range.
Postmenopausal breast cancer survivors without hormonal therapy will have greater gains in skeletal muscle mass compared to breast cancer survivors with Hormone Therapy (Aromatase Inhibitors or Tamoxifen) of the same age range after 12 weeks of progressive resistance-type exercise training.
Goals: The primary aim of this study is to compare the effects of a 12-week progressive resistance-type exercise training on muscle mass (whole body muscle mass) in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen).
Specific goals Determine whether resistance-type exercise training can increase muscle strength and quality of life in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen).
Identify whether circulating biochemical markers are up- or down-regulated in in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen) after resistance-type exercise training
Methodology:
Study design Twenty-six postmenopausal women between 45 to 59 years will be divided into two groups: participants without cancer (CLIMHEALTHY, n=13) and participants survivors of breast cancer without or with Hormone Therapy (CLIMCANCER, n=13). All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 12 weeks of training, whole-body dual energy x-ray absorptiometry (DEXA) scan will be performed for measured skeletal muscle mass and fasting blood samples will be obtained. Maximal strength will be determined by 1-repetition maximum (1RM), physical functioning by the short physical performance battery (SPPB) and quality of life by QLQ-BR23 at the same time points.
Study parameters/endpoints:
The main study endpoint is the increase in the skeletal muscle mass of whole-body assessed vial dual energy x-ray absorptiometry (DEXA).
Secondary endpoints include: Maximal strength assessment (1RM); Hand grip strength; Short physical performance battery (SPPB); quality of life (QLQ-BR23), Inflammatory and molecular markers (blood samples analysis).
Other study parameters include: Age, body weight, body height, body mass index (BMI), lipid profile, glucose, and insulin.
Expected results:
The impact of resistance-type exercise training to increase muscle mass in postmenopausal women survivors of breast cancer with or without hormonal therapy remains unclear. With the proposed project, the investigators expect that resistance-type exercise training will increase skeletal muscle mass, although the impact will be relatively lower in the participants survivors of breast cancer when compared with a group of healthy postmenopausal woman. The potential findings will define the efficacy of resistance-type exercise training to increase muscle mass in individuals with postmenopausal woman survivors of breast cancer. Better maintenance, or even an increase in muscle mass and strength increases independence, prolonging good health, recovery from disease and illness, and ultimately decreases burden on healthcare systems. These results will allow the creation of local, regional, national and international strategies to combat the adverse effects of breast cancer and its antineoplastic treatment, especially in postmenopausal women.
- Conditions
- Breast Cancer Survivors, Postmenopause, Resistance Training
- Being tested
- Prolonged resistance-type exercise training
- Keywords
- breast cancer, hormone therapy, exercise, muscle mass, strength
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged resistance-type exercise trainingOther
All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk).
| Study group | Role | What they receive |
|---|---|---|
| CLIMHEALTHY | Experimental | All postmenopausal women without breast cancer will be subjected to 12 weeks of full body resistance exercise training (3 times per week) Receives: Other: Prolonged resistance-type exercise training |
| CLIMCANCER | Experimental | All postmenopausal women survivors of breast cancer without or with Hormone Therapy (pecifically Aromatase Inhibitor or Tamoxifen) will be subjected to 12 weeks of full body resistance exercise training (3 times per week) Receives: Other: Prolonged resistance-type exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in skeletal muscle thickness, including measurements for the biceps, triceps brachii, rectus femoris, vastus intermedius, and the total quadriceps, will be assessed using muscular ultrasound after prolonged resistance-type exercise training
Measurements will be in centimeters.
Measured: Before, and after 12 weeks of training
Secondary outcomes (8)
Change in kilograms of the arms strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Maximal strength assessment via 1RM testing of horizontal row, lat pull down and chest press exercises
Measured: Before, and after 12 weeks of training
Change in kilograms of the legs strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Maximal strength assessment via 1RM testing of leg press, and leg extension exercises
Measured: Before, and after 12 weeks of training
Change in kilograms of the hand grip strength measured via JAMAR handheld dynamometer after prolonged resistance-type exercise training
Maximal strength assessment via 1RM testing of JAMAR handheld dynamometer
Measured: Before, and after 12 weeks of training
Change in points of the physical performance measured via Short physical performance battery (SPPB) after prolonged resistance-type exercise training
Measurement of physical performance via SPPB, the minimum value is 0 point and the maximum value is 12 points. Higher score in the Physical Performance mean a better outcome and lower score mean a worse outcome
Measured: Before, and after 12 weeks of training
Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) after prolonged resistance-type exercise training
Measurement of quality of life via EORTC QLQ-30, this questionnaire has 30 question covering functional state and cancer related symptoms. Besides, there are two specific question covering the "overall health" and "overall quality of life". The scores obtained are standardized and a score between 0 and 100 is obtained. High values on the global health and functional status scales indicate a better quality of life. However, high values on the symptom scale indicate a lower quality of life
Measured: Before, and after 12 weeks of training
Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA after prolonged resistance-type exercise training
Measurement in blood samples, the insulin will evaluate by ELISA using the Human Insulin ELISA Kit, following the manufacturer's recommendations
Measured: Before, and after 12 weeks of training
Change in milligrams per deciliter (mg/dL) of glucose via methods enzymatic-colorimetric
Measurement in blood samples, the glucose will determined by enzymatic-colorimetric methods using an automatic photometer.
Measured: Before, and after 12 weeks of training
Change in milligrams per deciliter (mg/dL) of lipid profile via methods enzymatic-colorimetric
Measurement in blood samples, the lipid profile will determined by enzymatic-colorimetric methods using an automatic photometer
Measured: Before, and after 12 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start22 Mar 2023
- Primary completion29 Mar 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Nasri Marzuca-Nassr, Universidad de La Frontera
- Investigators
- Gabriel N Marzuca-Nassr, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690295
- Sponsor's protocol ID
- DFP22-0020
- Acronym
- MUSCLE-CLIM
- Status last verified
- May 2024
- First submitted
- 22 Dec 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Artigas-Arias M, Munoz-Cofre R, Vidal-Seguel N, Alegria-Molina A, Sapunar J, Curi R, Marzuca-Nassr GN. Resistance exercise training similarly improves work efficiency and measured submaximal oxygen consumption during the 6-min walk test in healthy postmenopausal women and breast cancer survivors. Eur J Appl Physiol. 2026 Feb;126(2):965-977. doi: 10.1007/s00421-025-05966-0. Epub 2025 Sep 16.
PubMed 40954340Artigas-Arias M, Alegria-Molina A, Vidal-Seguel N, Munoz-Cofre R, Carranza-Leiva J, Sepulveda-Lara A, Vitzel KF, Huard N, Sapunar J, Salazar LA, Curi R, Marzuca-Nassr GN. Skeletal muscle mass, strength, and physical performance gains are similar between healthy postmenopausal women and postmenopausal breast cancer survivors after 12 weeks of resistance exercise training. Support Care Cancer. 2024 Nov 23;32(12):818. doi: 10.1007/s00520-024-08973-7.
PubMed 39579274
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Prolonged Resistance-type Exercise Training Between Healthy Postmenopausal Women Versus Postmenopausal Women Survivors of Breast Cancer
- ClinicalTrials.gov ID
- NCT05690295
- Acronym / sponsor ID
- MUSCLE-CLIM / DFP22-0020
- Conditions
- Breast Cancer Survivors, Postmenopause, Resistance Training
- Keywords
- breast cancer, hormone therapy, exercise, muscle mass, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 19 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.
Background: In postmenopausal women, an alteration in body composition occurs as a consequence of the secretion of low levels of serum estrogens by the ovaries. Observing an increase in abdominal and mammary fat mass and a decrease in skeletal muscle mass, which is also accompanied by loss of muscle strength and physical function, which leads early to a sarcopenia.
On the other hand, the increase in estrogen production by adipose tissue has been associated with an increased risk of breast cancer during menopause because the mammary parenchyma is particularly sensitive to this type of estrogen. For this reason, Hormone Therapy (Aromatase Inhibitors and Tamoxifen) is prescribed in women with estrogen receptor-positive breast cancer. Antineoplastic treatments (Chemotherapy and Hormonal Therapy) have contributed to non-metastatic breast cancer currently presenting a high survival rate, not without adverse effects associated with the course of the disease, age and antineoplastic treatment, affecting various systems, but particularly skeletal muscle mass.
Therefore, resistance exercise training has been proposed as an effective intervention strategy to increase muscle mass and strength in different populations. However, the level of muscle response to this type of training in postmenopausal women survivors of breast cancer with and without hormone treatment (Aromatase Inhibitors and Tamoxifen) is unknown.
Detailed description
Hypothesis: The increase in skeletal muscle mass after 12 weeks of progressive resistance-type exercise training is less in postmenopausal breast cancer survivors compared to healthy women of the same age range.
Postmenopausal breast cancer survivors without hormonal therapy will have greater gains in skeletal muscle mass compared to breast cancer survivors with Hormone Therapy (Aromatase Inhibitors or Tamoxifen) of the same age range after 12 weeks of progressive resistance-type exercise training.
Goals: The primary aim of this study is to compare the effects of a 12-week progressive resistance-type exercise training on muscle mass (whole body muscle mass) in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen).
Specific goals Determine whether resistance-type exercise training can increase muscle strength and quality of life in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen).
Identify whether circulating biochemical markers are up- or down-regulated in in healthy postmenopausal women versus postmenopausal women survivors of breast cancer with and without Hormone Therapy (Aromatase Inhibitors and Tamoxifen) after resistance-type exercise training
Methodology:
Study design Twenty-six postmenopausal women between 45 to 59 years will be divided into two groups: participants without cancer (CLIMHEALTHY, n=13) and participants survivors of breast cancer without or with Hormone Therapy (CLIMCANCER, n=13). All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). Before, and after 12 weeks of training, whole-body dual energy x-ray absorptiometry (DEXA) scan will be performed for measured skeletal muscle mass and fasting blood samples will be obtained. Maximal strength will be determined by 1-repetition maximum (1RM), physical functioning by the short physical performance battery (SPPB) and quality of life by QLQ-BR23 at the same time points.
Study parameters/endpoints:
The main study endpoint is the increase in the skeletal muscle mass of whole-body assessed vial dual energy x-ray absorptiometry (DEXA).
Secondary endpoints include: Maximal strength assessment (1RM); Hand grip strength; Short physical performance battery (SPPB); quality of life (QLQ-BR23), Inflammatory and molecular markers (blood samples analysis).
Other study parameters include: Age, body weight, body height, body mass index (BMI), lipid profile, glucose, and insulin.
Expected results:
The impact of resistance-type exercise training to increase muscle mass in postmenopausal women survivors of breast cancer with or without hormonal therapy remains unclear. With the proposed project, the investigators expect that resistance-type exercise training will increase skeletal muscle mass, although the impact will be relatively lower in the participants survivors of breast cancer when compared with a group of healthy postmenopausal woman. The potential findings will define the efficacy of resistance-type exercise training to increase muscle mass in individuals with postmenopausal woman survivors of breast cancer. Better maintenance, or even an increase in muscle mass and strength increases independence, prolonging good health, recovery from disease and illness, and ultimately decreases burden on healthcare systems. These results will allow the creation of local, regional, national and international strategies to combat the adverse effects of breast cancer and its antineoplastic treatment, especially in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLIMHEALTHY | Experimental | Other: Prolonged resistance-type exercise trainingAll postmenopausal women without breast cancer will be subjected to 12 weeks of full body resistance exercise training (3 times per week) |
| CLIMCANCER | Experimental | Other: Prolonged resistance-type exercise trainingAll postmenopausal women survivors of breast cancer without or with Hormone Therapy (pecifically Aromatase Inhibitor or Tamoxifen) will be subjected to 12 weeks of full body resistance exercise training (3 times per week) |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy postmenopausal women and postmenopausal women survivors of breast cancer with and without Hormonal Therapy (Aromatase Inhibitors and Tamoxifen) between 45 to 59 years.
- Women survivors of breast cancer with active Hormone Therapy in the last 12 months.
- Women breast cancer survivors with luminal molecular profile and positive estrogen receptors.
- Body mass index 18.5 < BMI < 30 kg/m2.
- Volunteers without cognitive impairment (abbreviated Minimental >13 points).
Key exclusion criteria (5 listed)
- Active antineoplastic treatment in the last 12 months.
- >200 mL of volume difference between upper limbs and/or stage IV breast cancer.
- Performing regular resistance training (2 or more times per week, carrying out progressive training) in the previous 6 months.
- Cardiovascular diseases that are contradictory for physical activity (not included controlled Hypertension).
- All co-morbidities interacting with mobility and muscle metabolism of the body and that do not allow to (safely) perform the resistance-type exercise training (e.g. debilitating arthritis, spasticity/rigidity, all neurological disorders and paralysis).
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 |
|---|---|---|
| Prolonged resistance-type exercise trainingAll volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk). | Other | CLIMCANCER, CLIMHEALTHY |
Primary outcome
The changes in skeletal muscle thickness, including measurements for the biceps, triceps brachii, rectus femoris, vastus intermedius, and the total quadriceps, will be assessed using muscular ultrasound after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Measurements will be in centimeters.
8 secondary outcomes
Change in kilograms of the arms strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Change in kilograms of the legs strength measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Change in kilograms of the hand grip strength measured via JAMAR handheld dynamometer after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Change in points of the physical performance measured via Short physical performance battery (SPPB) after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA after prolonged resistance-type exercise training
Time frame: Before, and after 12 weeks of training
Change in milligrams per deciliter (mg/dL) of glucose via methods enzymatic-colorimetric
Time frame: Before, and after 12 weeks of training
Change in milligrams per deciliter (mg/dL) of lipid profile via methods enzymatic-colorimetric
Time frame: Before, and after 12 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 40954340Artigas-Arias M, Munoz-Cofre R, Vidal-Seguel N, Alegria-Molina A, Sapunar J, Curi R, Marzuca-Nassr GN. Resistance exercise training similarly improves work efficiency and measured submaximal oxygen consumption during the 6-min walk test in healthy postmenopausal women and breast cancer survivors. Eur J Appl Physiol. 2026 Feb;126(2):965-977. doi: 10.1007/s00421-025-05966-0. Epub 2025 Sep 16.
- Derived from this study: PubMed 39579274Artigas-Arias M, Alegria-Molina A, Vidal-Seguel N, Munoz-Cofre R, Carranza-Leiva J, Sepulveda-Lara A, Vitzel KF, Huard N, Sapunar J, Salazar LA, Curi R, Marzuca-Nassr GN. Skeletal muscle mass, strength, and physical performance gains are similar between healthy postmenopausal women and postmenopausal breast cancer survivors after 12 weeks of resistance exercise training. Support Care Cancer. 2024 Nov 23;32(12):818. doi: 10.1007/s00520-024-08973-7.
- 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.
Gabriel N Marzuca-Nassr principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged resistance-type exercise training in people with Breast Cancer Survivors and Postmenopause, run by Universidad de La Frontera at 1 site in Chile.
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 5 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: finished, as of the sponsor's last update on 17 May 2024. 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in skeletal muscle thickness, including measurements for the biceps, triceps brachii, rectus femoris, vastus intermedius, and the total quadriceps, will be assessed using muscular ultrasound after prolonged resistance-type exercise training (time frame: Before, and after 12 weeks of training). 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 NCT05690295, which also lists 2 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 17 May 2024.