Chronic Kidney DiseasesNCT03779126
Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
A study testing Electrical stimulation in people with Chronic Kidney Diseases, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 30 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease
- Classical hemodialysis
- Over 18 years old
- No pace maker
- Without cognitive or motor deficit
- No regular physical activity in the last six months
Who cannot join
- Abstention for more than two consecutive sessions or four in total
- Inability to perform the tests
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospitalsiriolibanes
São Paulo, 01308-050
Wellington Yamaguti, 551131550393, wellington.psyamaguti@hsl.org.br
Igor Moraes, 551131550200, Igorgutierrezmoraes@yahoo.com.br
About this study
Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.
Read the detailed description
Patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the Informed Consent Term. On the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, Medical Research Council (MRC) and biochemical markers. On the second day, anthropometry, body composition and functional capacity will be performed. On the third day, the muscular function will be assessed by isokinetic evaluation. After completing the evaluations, patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and high frequency (LHF), and sham.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Electrical stimulation
- Keywords
- Chronic Kidney Disease, Electrical stimulation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationDevice
Also called Low frequency electrical stimulation (LF), High frequency (HF), Low and High frequency (LHF), sham stimulation
- Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator | Experimental | Low frequency electrical stimulation for 60 minutes, three times a week during 60 days. Receives: Device: Electrical stimulation |
| Other | Experimental | High frequency electrical stimulation for 60 minutes, three times a week during 60 days. Receives: Device: Electrical stimulation |
| Experimental group | Experimental | Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days. Receives: Device: Electrical stimulation |
| Placebo | Placebo comparator | Placebo electrical stimulation for 60 minutes, three times a week during 60 days. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current Receives: Device: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the improvement of muscle mass
The muscle mass will be assessed by electric bioimpedance
Measured: Eight weeks
Assess the improvement of muscle strength
The muscle strength will be assessed using isokinetic by peak torque
Measured: Eight weeks
Assess the improvement of muscle resistance
The muscle resistance will be assessed using isokinetic by fatigue index
Measured: Eight weeks
Secondary outcomes (7)
Assess the improvement of intervention in quality of life
The quality of life will be assessed by kidney disease quality of life-short form questionnaire (KDQOL-SF).It is eighty questions about physical aspects, economical and psychological with 80 items. The range could be from 0 to 100. A less score reflect better quality of life.
Measured: Eight weeks
Correlate peripheral muscle function using medical research council score with nutritional status
Peripheral muscle strength will be assessed by medical research council score. It is a score which measure the muscle strength in six plans of movement with range 0 to 60. Higher values represent a better outcome. The findings will be correlated with biomarkers (urea, creatinine, ferritin, lactate and insulin growth factor 1).
Measured: Eight weeks
Correlate peripheral muscle function using hand grip with nutritional status
Peripheral muscle strength will be assessed by hand grip strength. It is a measure the hand grip strength with range 0 to 120 pounds. Higher values represent a better outcome.The findings will be correlated with biomarkers (urea, creatinine, ferritin, lactate and insulin growth factor 1).
Measured: Eight weeks
Correlate peripheral muscle function with body composition
Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius)
Measured: Eight weeks
Correlate peripheral muscle function with functional capacity
Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test.
Measured: Eight weeks
Assess the improvement of intervention in hemodialysis effusion
The hemodialysis efficacy will be assessed by Kt/v
Measured: Eight weeks
Assess the improvement of intervention in functional capacity
Functional capacity will be assessed using six minute step test
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be randomised in four groups: 1) low frequency electrical stimulation (LF), 2) high frequency (HF), low and High frequency (LHF), and sham. The subjects will receive electrical stimulation in quadriceps bilaterally for 60 minutes , three times per week, during two months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wellington Yamaguti, Hospital Sirio-Libanes
- Investigators
- Wellington PS Yamaguti, Phd, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779126
- Sponsor's protocol ID
- HSL 2017-95
- Status last verified
- Oct 2023
- First submitted
- 6 Nov 2018
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva VG, Amaral C, Monteiro MB, Nascimento DM, Boschetti JR. Effects of inspiratory muscle training in hemodialysis patients. J Bras Nefrol. 2011 Mar;33(1):62-8. English, Portuguese.
PubMed 21541465Hirai K, Ookawara S, Morishita Y. Sarcopenia and Physical Inactivity in Patients With Chronic Kidney Disease. Nephrourol Mon. 2016 Apr 26;8(3):e37443. doi: 10.5812/numonthly.37443. eCollection 2016 May.
PubMed 27570755Eidemak I, Haaber AB, Feldt-Rasmussen B, Kanstrup IL, Strandgaard S. Exercise training and the progression of chronic renal failure. Nephron. 1997;75(1):36-40. doi: 10.1159/000189497.
PubMed 9031268Kopple JD, Wang H, Casaburi R, Fournier M, Lewis MI, Taylor W, Storer TW. Exercise in maintenance hemodialysis patients induces transcriptional changes in genes favoring anabolic muscle. J Am Soc Nephrol. 2007 Nov;18(11):2975-86. doi: 10.1681/ASN.2006070794. Epub 2007 Oct 17. No abstract available.
PubMed 17942969Koh KP, Fassett RG, Sharman JE, Coombes JS, Williams AD. Effect of intradialytic versus home-based aerobic exercise training on physical function and vascular parameters in hemodialysis patients: a randomized pilot study. Am J Kidney Dis. 2010 Jan;55(1):88-99. doi: 10.1053/j.ajkd.2009.09.025. Epub 2009 Nov 22.
PubMed 19932545Klassen A, Racasan S, Gherman-Caprioara M, Kurner B, Blaser C, Bahner U, Heidland A. High-tone external muscle stimulation in endstage renal disease: effects on quality of life in patients with peripheral neuropathy. Clin Nephrol. 2013 Jan;79 Suppl 1:S28-33.
PubMed 23249530Di Iorio B, Torraca S, Gustaferro P, Fazeli G, Heidland A. High-frequency external muscle stimulation in acute kidney injury (AKI): potential shortening of its clinical course. Clin Nephrol. 2013 Jan;79 Suppl 1:S37-45.
PubMed 23249532Bruggemann AK, Mello CL, Dal Pont T, Hizume Kunzler D, Martins DF, Bobinski F, Pereira Yamaguti W, Paulin E. Effects of Neuromuscular Electrical Stimulation During Hemodialysis on Peripheral Muscle Strength and Exercise Capacity: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):822-831.e1. doi: 10.1016/j.apmr.2016.12.009. Epub 2017 Jan 16.
PubMed 28093194Sesso RC, Lopes AA, Thome FS, Lugon JR, Martins CT. Brazilian Chronic Dialysis Census 2014. J Bras Nefrol. 2016 Mar;38(1):54-61. doi: 10.5935/0101-2800.20160009. English, Portuguese.
PubMed 27049365Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
PubMed 7841967Duarte PS, Ciconelli RM, Sesso R. Cultural adaptation and validation of the "Kidney Disease and Quality of Life--Short Form (KDQOL-SF 1.3)" in Brazil. Braz J Med Biol Res. 2005 Feb;38(2):261-70. doi: 10.1590/s0100-879x2005000200015. Epub 2005 Feb 15.
PubMed 15785838Franssen FM, Broekhuizen R, Janssen PP, Wouters EF, Schols AM. Limb muscle dysfunction in COPD: effects of muscle wasting and exercise training. Med Sci Sports Exerc. 2005 Jan;37(1):2-9. doi: 10.1249/01.mss.0000150082.59155.4f.
PubMed 15632660Hough CL, Lieu BK, Caldwell ES. Manual muscle strength testing of critically ill patients: feasibility and interobserver agreement. Crit Care. 2011;15(1):R43. doi: 10.1186/cc10005. Epub 2011 Jan 28.
PubMed 21276225Desrosiers J, Bravo G, Hebert R, Dutil E. Normative data for grip strength of elderly men and women. Am J Occup Ther. 1995 Jul-Aug;49(7):637-44. doi: 10.5014/ajot.49.7.637.
PubMed 7573334Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
- ClinicalTrials.gov ID
- NCT03779126
- Acronym / sponsor ID
- HSL 2017-95
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease, Electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Dec 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.
Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.
Detailed description
Patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the Informed Consent Term. On the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, Medical Research Council (MRC) and biochemical markers. On the second day, anthropometry, body composition and functional capacity will be performed. On the third day, the muscular function will be assessed by isokinetic evaluation. After completing the evaluations, patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and high frequency (LHF), and sham.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The subjects will be randomised in four groups: 1) low frequency electrical stimulation (LF), 2) high frequency (HF), low and High frequency (LHF), and sham. The subjects will receive electrical stimulation in quadriceps bilaterally for 60 minutes , three times per week, during two months.
| Arm | Type | Receives |
|---|---|---|
| Active comparator | Experimental | Device: Electrical stimulationLow frequency electrical stimulation for 60 minutes, three times a week during 60 days. |
| Other | Experimental | Device: Electrical stimulationHigh frequency electrical stimulation for 60 minutes, three times a week during 60 days. |
| Experimental group | Experimental | Device: Electrical stimulationLow and High frequency electrical stimulation for 60 minutes, three times a week during 60 days. |
| Placebo | Placebo comparator | Device: Electrical stimulationPlacebo electrical stimulation for 60 minutes, three times a week during 60 days. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic kidney disease
- Classical hemodialysis
- Over 18 years old
- No pace maker
- Without cognitive or motor deficit
Key exclusion criteria (2 listed)
- Abstention for more than two consecutive sessions or four in total
- Inability to perform the tests
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 |
|---|---|---|
| Electrical stimulationAlso: Low frequency electrical stimulation (LF), High frequency (HF), Low and High frequency (LHF), sham stimulation1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months. | Device | Active comparator, Experimental group, Other, Placebo |
Primary outcome
Assess the improvement of muscle mass
Time frame: Eight weeks
The muscle mass will be assessed by electric bioimpedance
Assess the improvement of muscle strength
Time frame: Eight weeks
The muscle strength will be assessed using isokinetic by peak torque
Assess the improvement of muscle resistance
Time frame: Eight weeks
The muscle resistance will be assessed using isokinetic by fatigue index
7 secondary outcomes
Assess the improvement of intervention in quality of life
Time frame: Eight weeks
Correlate peripheral muscle function using medical research council score with nutritional status
Time frame: Eight weeks
Correlate peripheral muscle function using hand grip with nutritional status
Time frame: Eight weeks
Correlate peripheral muscle function with body composition
Time frame: Eight weeks
Correlate peripheral muscle function with functional capacity
Time frame: Eight weeks
Assess the improvement of intervention in hemodialysis effusion
Time frame: Eight weeks
Assess the improvement of intervention in functional capacity
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 21541465Silva VG, Amaral C, Monteiro MB, Nascimento DM, Boschetti JR. Effects of inspiratory muscle training in hemodialysis patients. J Bras Nefrol. 2011 Mar;33(1):62-8. English, Portuguese.
- Background: PubMed 27570755Hirai K, Ookawara S, Morishita Y. Sarcopenia and Physical Inactivity in Patients With Chronic Kidney Disease. Nephrourol Mon. 2016 Apr 26;8(3):e37443. doi: 10.5812/numonthly.37443. eCollection 2016 May.
- Background: PubMed 9031268Eidemak I, Haaber AB, Feldt-Rasmussen B, Kanstrup IL, Strandgaard S. Exercise training and the progression of chronic renal failure. Nephron. 1997;75(1):36-40. doi: 10.1159/000189497.
- Background: PubMed 17942969Kopple JD, Wang H, Casaburi R, Fournier M, Lewis MI, Taylor W, Storer TW. Exercise in maintenance hemodialysis patients induces transcriptional changes in genes favoring anabolic muscle. J Am Soc Nephrol. 2007 Nov;18(11):2975-86. doi: 10.1681/ASN.2006070794. Epub 2007 Oct 17. No abstract available.
- Background: PubMed 19932545Koh KP, Fassett RG, Sharman JE, Coombes JS, Williams AD. Effect of intradialytic versus home-based aerobic exercise training on physical function and vascular parameters in hemodialysis patients: a randomized pilot study. Am J Kidney Dis. 2010 Jan;55(1):88-99. doi: 10.1053/j.ajkd.2009.09.025. Epub 2009 Nov 22.
- Background: PubMed 23249530Klassen A, Racasan S, Gherman-Caprioara M, Kurner B, Blaser C, Bahner U, Heidland A. High-tone external muscle stimulation in endstage renal disease: effects on quality of life in patients with peripheral neuropathy. Clin Nephrol. 2013 Jan;79 Suppl 1:S28-33.
- Background: PubMed 23249532Di Iorio B, Torraca S, Gustaferro P, Fazeli G, Heidland A. High-frequency external muscle stimulation in acute kidney injury (AKI): potential shortening of its clinical course. Clin Nephrol. 2013 Jan;79 Suppl 1:S37-45.
- Background: PubMed 28093194Bruggemann AK, Mello CL, Dal Pont T, Hizume Kunzler D, Martins DF, Bobinski F, Pereira Yamaguti W, Paulin E. Effects of Neuromuscular Electrical Stimulation During Hemodialysis on Peripheral Muscle Strength and Exercise Capacity: A Randomized Clinical Trial. Arch Phys Med Rehabil. 2017 May;98(5):822-831.e1. doi: 10.1016/j.apmr.2016.12.009. Epub 2017 Jan 16.
- Background: PubMed 27049365Sesso RC, Lopes AA, Thome FS, Lugon JR, Martins CT. Brazilian Chronic Dialysis Census 2014. J Bras Nefrol. 2016 Mar;38(1):54-61. doi: 10.5935/0101-2800.20160009. English, Portuguese.
- Background: PubMed 7841967Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
- Background: PubMed 15785838Duarte PS, Ciconelli RM, Sesso R. Cultural adaptation and validation of the "Kidney Disease and Quality of Life--Short Form (KDQOL-SF 1.3)" in Brazil. Braz J Med Biol Res. 2005 Feb;38(2):261-70. doi: 10.1590/s0100-879x2005000200015. Epub 2005 Feb 15.
- Background: PubMed 15632660Franssen FM, Broekhuizen R, Janssen PP, Wouters EF, Schols AM. Limb muscle dysfunction in COPD: effects of muscle wasting and exercise training. Med Sci Sports Exerc. 2005 Jan;37(1):2-9. doi: 10.1249/01.mss.0000150082.59155.4f.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Wellington PS Yamaguti, Phd principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation in people with Chronic Kidney Diseases, run by Hospital Sirio-Libanes 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 6 inclusion and 2 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 26 Oct 2023. 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. Some participants in this study may receive a placebo. 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 Wellington PS Yamaguti, Phd (1133940200 ext. 4395, wellington.psyamaguti@hsl.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the improvement of muscle mass (time frame: Eight weeks). The study lists 3 primary outcomes in all. 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 NCT03779126, which also lists 24 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 26 Oct 2023.