Breast Cancer SurvivorsNCT03644329
Effect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors.
A study testing Lower-load resistance training (LL), Higher-load resistance training (HL) and Higher-volume resistance training (HV) in people with Breast Cancer Survivors and Postmenopause, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
Trial summary
This study intends to evaluate the impact of resistance training variable manipulation (intensity and volume) on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer Survivors, Postmenopause
- What is being tested?
- Lower-load resistance training (LL), Higher-load resistance training (HL) and Higher-volume resistance training (HV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 13 May 2018to 20 Dec 2019
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal breast cancer survivors;
- No supervised or unsupervised exercise at least for six months prior to the study.
Who cannot join
- Alcoholics;
- No controlled blood pressure and glucose;
- Presence of myopathies, arthropathies, and neuropathies;
- Presence of muscle, thromboembolic and gastrointestinal disorders, infection diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Post-degree program in physical education
Uberaba, MG - Minas Gerais, 38061-500
Fabio L Orsatti, PhD, +55 34 3700-6634, fabiorsatti@gmail.com
About this study
Official title: Effect of Resistance Training Variable Manipulation (Intensity and Volume) on Body Composition, Fatigability and Functional Capacity in Postmenopausal Breast Cancer Survivors.
This study intends to evaluate the impact of resistance training variable manipulation (intensity and volume) on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.
Read the detailed description
The treatment for breast cancer (chemotherapy, radiotherapy and hormone therapy) provokes collateral effects,such as muscle mass and strength losses, increase of fat mass, fatigue and disability and reduced quality of life in postmenopausal breast cancer survivors. The resistance training is assumed as a non-pharmacologic interventions in postmenopausal breast cancer survivors. However, it is unclear whether the manipulation of training variables (intensity and volume) maximize the effects of resistance training on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.
- Conditions
- Breast Cancer Survivors, Postmenopause
- Being tested
- Control group, Lower-load resistance training (LL), Higher-load resistance training (HL), Higher-volume resistance training (HV)
- Keywords
- Breast Cancer Survivors, resistance Training, fatigability, Body Composition, Functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
The volunteers will not performed the interventions.
Lower-load resistance training (LL)Other
The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 30% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
Higher-load resistance training (HL)Other
The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
Higher-volume resistance training (HV)Other
The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, six sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control group, CT | Other | In the CT, the postmenopausal breast cancer survivers does not perform exercise. Receives: Other: Control group |
| Lower-load resistance training (LL) | Experimental | In the LL, the postmenopausal breast cancer survivers will be submitted to 12 weeks of resistance training with low loads ( i.e. three sets with 30% of one-repetition maximum). Receives: Other: Lower-load resistance training (LL) |
| Higher-load resistance training (HL) | Experimental | In the HL, the postmenopausal breast cancer survivers will be submitted to 12 weeks of resistance training with high loads (i.e. three sets with 80% of one maximum repetition). Receives: Other: Higher-load resistance training (HL) |
| Higher-volume resistance training (HV) | Experimental | In the HV, the postmenopause breast cancer survivers will be submitted to 12 weeks of resistance training with high volume ( i.e. six sets with 80% one maximum repetition). Receives: Other: Higher-volume resistance training (HV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the Fatigability
The fatigability will be evaluate by 60 maximum voluntary isometric contractions (3 s contraction, 2 s rest) in knee extensors at 70 degree
Measured: pre and post intervention (i.e. 12 weeks)
Secondary outcomes (10)
Four- meter walk test
The volunteers will walk 4 meter. The time will be computed to determine the gait velocity (m/s).
Measured: pre and post intervention (i.e. 12 weeks)
Fat mass
The fat mass (kg) will be assessed via dual-energy x-ray absorptiometry scanning (iDXA; GE Healthcare-Luna, Madison, WI; software Encore version 14.10).
Measured: pre intervention and post intervention (i.e. 12 weeks)
Muscle strength
Muscle strength will be evaluated by one repetition maximum (1RM) test.
Measured: pre and post intervention (i.e. 12 weeks)
Six Minutes-walk test (6MWT)
The volunteers will walk 6 minutes. The distance (meters) will be recorded after completes the test. The 6MWT will be performed indoor, on a flat floor in a sports court.
Measured: pre and post intervention (i.e. 12 weeks)
Timed Up and Go test
The volunteers will be advised to get up from a chair, walk three meters, turn around, go back to the chair, and sit down. The time (seconds) will be recorded. The test will be performed indoor, on a flat floor in a sports court.
Measured: pre and post intervention (i.e. 12 weeks)
Five-times-sit-to-stand test
The volunteers will rise from a chair and returned to the seated position as quickly as possible for five repetitions. The time will be recorded (seconds).
Measured: pre and post intervention (i.e. 12 weeks)
Muscle mass
The muscle mass (kg) will be assessed via dual-energy x-ray absorptiometry scanning (iDXA; GE Healthcare-Luna, Madison, WI; software Encore version 14.10).
Measured: pre and post intervention (i.e. 12 weeks)
10-meter walk test
The volunteers will walk 10 meters. The gait speed will be evaluated (m/s). The test will be performed indoor, on a flat floor in a sports court.
Measured: pre and post intervention (i.e. 12 weeks)
400-meter walk test
The volunteers will walk 400 meters. The gait speed will be evaluated (m/s). The test will be performed indoor, on a flat floor in a sports court.
Measured: pre and post intervention (i.e. 12 weeks)
900-meter walk test
The volunteers will walk 900 meters. The gait speed will be evaluate (m/s). The test will be performed indoor, on a flat floor in a sports court.
Measured: pre and post intervention (i.e. 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start13 May 2018
- Primary completion10 Nov 2018 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro
- Investigators
- Fábio L Orsatti, PhD, Principal investigator, Federal University of Triângulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644329
- Sponsor's protocol ID
- CAAE: 82691818.0.0000.5154
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmes J, Powell-Griner E, Lethbridge-Cejku M, Heyman K. Aging differently: Physical limitations among adults aged 50 years and over: United States, 2001-2007. NCHS Data Brief. 2009 Jul;(20):1-8. No abstract available.
PubMed 19627658Martin LG, Freedman VA, Schoeni RF, Andreski PM. Trends in disability and related chronic conditions among people ages fifty to sixty-four. Health Aff (Millwood). 2010 Apr;29(4):725-31. doi: 10.1377/hlthaff.2008.0746.
PubMed 20368601Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
PubMed 10811152Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.
PubMed 7838189McGinn AP, Kaplan RC, Verghese J, Rosenbaum DM, Psaty BM, Baird AE, Lynch JK, Wolf PA, Kooperberg C, Larson JC, Wassertheil-Smoller S. Walking speed and risk of incident ischemic stroke among postmenopausal women. Stroke. 2008 Apr;39(4):1233-9. doi: 10.1161/STROKEAHA.107.500850. Epub 2008 Feb 21.
PubMed 18292379Freiberger E, de Vreede P, Schoene D, Rydwik E, Mueller V, Frandin K, Hopman-Rock M. Performance-based physical function in older community-dwelling persons: a systematic review of instruments. Age Ageing. 2012 Nov;41(6):712-21. doi: 10.1093/ageing/afs099. Epub 2012 Aug 10.
PubMed 22885845Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
PubMed 11856064Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
PubMed 8126356Lyons RA, Perry HM, Littlepage BN. Evidence for the validity of the Short-form 36 Questionnaire (SF-36) in an elderly population. Age Ageing. 1994 May;23(3):182-4. doi: 10.1093/ageing/23.3.182.
PubMed 8085500Nunes PRP, Oliveira AA, Martins FM, Souza AP, Orsatti FL. Effect of resistance training volume on walking speed performance in postmenopausal women: A randomized controlled trial. Exp Gerontol. 2017 Oct 15;97:80-88. doi: 10.1016/j.exger.2017.08.011. Epub 2017 Aug 10.
PubMed 28804047Straight CR, Brady AO, Evans E. Sex-specific relationships of physical activity, body composition, and muscle quality with lower-extremity physical function in older men and women. Menopause. 2015 Mar;22(3):297-303. doi: 10.1097/GME.0000000000000313.
PubMed 25137244Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Buchner DM, Larson EB, Wagner EH, Koepsell TD, de Lateur BJ. Evidence for a non-linear relationship between leg strength and gait speed. Age Ageing. 1996 Sep;25(5):386-91. doi: 10.1093/ageing/25.5.386.
PubMed 8921145Reid KF, Fielding RA. Skeletal muscle power: a critical determinant of physical functioning in older adults. Exerc Sport Sci Rev. 2012 Jan;40(1):4-12. doi: 10.1097/JES.0b013e31823b5f13.
PubMed 22016147Rantanen T, Guralnik JM, Ferrucci L, Penninx BW, Leveille S, Sipila S, Fried LP. Coimpairments as predictors of severe walking disability in older women. J Am Geriatr Soc. 2001 Jan;49(1):21-7. doi: 10.1046/j.1532-5415.2001.49005.x.
PubMed 11207838
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training Variable Manipulation (Intensity and Volume) on Body Composition, Fatigability and Functional Capacity in Postmenopausal Breast Cancer Survivors.
- ClinicalTrials.gov ID
- NCT03644329
- Acronym / sponsor ID
- CAAE: 82691818.0.0000.5154
- Conditions
- Breast Cancer Survivors, Postmenopause
- Keywords
- Breast Cancer Survivors, resistance Training, fatigability, Body Composition, Functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- 13 May 2018 (actual)
- Primary completion
- 10 Nov 2018 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 23 Aug 2018 (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 intends to evaluate the impact of resistance training variable manipulation (intensity and volume) on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.
Detailed description
The treatment for breast cancer (chemotherapy, radiotherapy and hormone therapy) provokes collateral effects,such as muscle mass and strength losses, increase of fat mass, fatigue and disability and reduced quality of life in postmenopausal breast cancer survivors. The resistance training is assumed as a non-pharmacologic interventions in postmenopausal breast cancer survivors. However, it is unclear whether the manipulation of training variables (intensity and volume) maximize the effects of resistance training on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group, CT | Other | Other: Control groupIn the CT, the postmenopausal breast cancer survivers does not perform exercise. |
| Lower-load resistance training (LL) | Experimental | Other: Lower-load resistance training (LL)In the LL, the postmenopausal breast cancer survivers will be submitted to 12 weeks of resistance training with low loads ( i.e. three sets with 30% of one-repetition maximum). |
| Higher-load resistance training (HL) | Experimental | Other: Higher-load resistance training (HL)In the HL, the postmenopausal breast cancer survivers will be submitted to 12 weeks of resistance training with high loads (i.e. three sets with 80% of one maximum repetition). |
| Higher-volume resistance training (HV) | Experimental | Other: Higher-volume resistance training (HV)In the HV, the postmenopause breast cancer survivers will be submitted to 12 weeks of resistance training with high volume ( i.e. six sets with 80% one maximum repetition). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal breast cancer survivors;
- No supervised or unsupervised exercise at least for six months prior to the study.
Key exclusion criteria (4 listed)
- Alcoholics;
- No controlled blood pressure and glucose;
- Presence of myopathies, arthropathies, and neuropathies;
- Presence of muscle, thromboembolic and gastrointestinal disorders, infection diseases.
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 |
|---|---|---|
| Control groupThe volunteers will not performed the interventions. | Other | Control group, CT |
| Lower-load resistance training (LL)The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 30% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises. | Other | Lower-load resistance training (LL) |
| Higher-load resistance training (HL)The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises. | Other | Higher-load resistance training (HL) |
| Higher-volume resistance training (HV)The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, six sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises. | Other | Higher-volume resistance training (HV) |
Primary outcome
Evaluation the Fatigability
Time frame: pre and post intervention (i.e. 12 weeks)
The fatigability will be evaluate by 60 maximum voluntary isometric contractions (3 s contraction, 2 s rest) in knee extensors at 70 degree
10 secondary outcomes
Four- meter walk test
Time frame: pre and post intervention (i.e. 12 weeks)
Fat mass
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Muscle strength
Time frame: pre and post intervention (i.e. 12 weeks)
Six Minutes-walk test (6MWT)
Time frame: pre and post intervention (i.e. 12 weeks)
Timed Up and Go test
Time frame: pre and post intervention (i.e. 12 weeks)
Five-times-sit-to-stand test
Time frame: pre and post intervention (i.e. 12 weeks)
Muscle mass
Time frame: pre and post intervention (i.e. 12 weeks)
10-meter walk test
Time frame: pre and post intervention (i.e. 12 weeks)
400-meter walk test
Time frame: pre and post intervention (i.e. 12 weeks)
900-meter walk test
Time frame: pre and post intervention (i.e. 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 19627658Holmes J, Powell-Griner E, Lethbridge-Cejku M, Heyman K. Aging differently: Physical limitations among adults aged 50 years and over: United States, 2001-2007. NCHS Data Brief. 2009 Jul;(20):1-8. No abstract available.
- Background: PubMed 20368601Martin LG, Freedman VA, Schoeni RF, Andreski PM. Trends in disability and related chronic conditions among people ages fifty to sixty-four. Health Aff (Millwood). 2010 Apr;29(4):725-31. doi: 10.1377/hlthaff.2008.0746.
- Background: PubMed 10811152Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
- Background: PubMed 7838189Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.
- Background: PubMed 18292379McGinn AP, Kaplan RC, Verghese J, Rosenbaum DM, Psaty BM, Baird AE, Lynch JK, Wolf PA, Kooperberg C, Larson JC, Wassertheil-Smoller S. Walking speed and risk of incident ischemic stroke among postmenopausal women. Stroke. 2008 Apr;39(4):1233-9. doi: 10.1161/STROKEAHA.107.500850. Epub 2008 Feb 21.
- Background: PubMed 22885845Freiberger E, de Vreede P, Schoene D, Rydwik E, Mueller V, Frandin K, Hopman-Rock M. Performance-based physical function in older community-dwelling persons: a systematic review of instruments. Age Ageing. 2012 Nov;41(6):712-21. doi: 10.1093/ageing/afs099. Epub 2012 Aug 10.
- Background: PubMed 11856064Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
- Background: PubMed 8126356Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
- Background: PubMed 8085500Lyons RA, Perry HM, Littlepage BN. Evidence for the validity of the Short-form 36 Questionnaire (SF-36) in an elderly population. Age Ageing. 1994 May;23(3):182-4. doi: 10.1093/ageing/23.3.182.
- Background: PubMed 28804047Nunes PRP, Oliveira AA, Martins FM, Souza AP, Orsatti FL. Effect of resistance training volume on walking speed performance in postmenopausal women: A randomized controlled trial. Exp Gerontol. 2017 Oct 15;97:80-88. doi: 10.1016/j.exger.2017.08.011. Epub 2017 Aug 10.
- Background: PubMed 25137244Straight CR, Brady AO, Evans E. Sex-specific relationships of physical activity, body composition, and muscle quality with lower-extremity physical function in older men and women. Menopause. 2015 Mar;22(3):297-303. doi: 10.1097/GME.0000000000000313.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- 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.
Fábio L Orsatti, PhD principal investigator
Federal University of Triângulo Mineiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower-load resistance training (LL), Higher-load resistance training (HL) and Higher-volume resistance training (HV) in people with Breast Cancer Survivors and Postmenopause, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
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 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fábio L Orsatti, PhD (+55343700-6634, fabiorsatti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the Fatigability (time frame: pre and post intervention (i.e. 12 weeks)). 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 NCT03644329, which also lists 58 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 23 Aug 2018; AzTrials last refreshed its copy on 2 Nov 2026.