Diabetes Mellitus, Type 2NCT03593746
Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients
A study testing Physical training and Light-Emitting Diode (LED) therapy in people with Diabetes Mellitus, Type 2 and High-Intensity Interval Training, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Diabetes has become a widespread epidemic, primarily because of the increasing prevalence and incidence of type 2 diabetes (T2D). T2D is a significant cause of premature mortality and morbidity related to cardiovascular disease, blindness, kidney and nerve disease, and amputation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, High-Intensity Interval Training, Exercise Training
- What is being tested?
- Physical training and Light-Emitting Diode (LED) therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2020to Dec 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Confirmed diagnosis of type 2 diabetes;
- Sedentary lifestyle in the last six months, according to the criteria established by the American Heart Association (AHA).
Who cannot join
- Confirmed diagnosis of any (1) heart disease; (2) musculoskeletal disorder; (3) respiratory disease; (4) uncontrolled arterial hypertension; (5) peripheral neuropathy or (6) factors that limit the performance of any of the study evaluations and/or training.
- During the study, individuals with a presence of less than 80% in the training sessions will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
UNINOVE
São Paulo, São Paulo, 03332010
Luciana Sampaio, PhD
About this study
Official title: Effects of High Intensity Interval Training and Combined Training Associated With Photobiomodulation in Type 2 Diabetic (T2D) Patients: a Randomized Controlled Clinical Trial
Diabetes has become a widespread epidemic, primarily because of the increasing prevalence and incidence of type 2 diabetes (T2D). T2D is a significant cause of premature mortality and morbidity related to cardiovascular disease, blindness, kidney and nerve disease, and amputation.
Physical activity improves blood glucose control and can prevent or delay T2D, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life. At present, although physical activity is a key element in the prevention and management of T2D, the most effective exercise strategy (intensity, duration, and type of exercise) for improving glucose control and reducing cardiometabolic risk in type 2 diabetes has not been defined.
Read more
Studies with Light-Emitting Diode (LED) therapy have demonstrated its ability to promote pain relief, improve muscle and cardiopulmonary performance, minimize muscle fatigue, and stimulate wound healing. In relation to patients with T2D, who have prolonged conditions of hyperglycemia, studies to investigate the impact of photobiomodulation associated with physical training have not been found so far.
The objective of this study is to investigate the effects of different types of physical training associated with Light-Emitting Diode (LED) therapy on cardiometabolic status and quality of life in patients with T2D.
Read the detailed description
Type 2 diabetes (T2D) is a significant health problem worldwide due to its high prevalence and mortality. It is chronic metabolic disorder characterized by hyperglycemia resulting from a relative deficiency in insulin through either reduced insulin secretion or reduced insulin action or both. The subsequent chronic hyperglycaemia causes glycation of tissues, which almost inevitably leads to acute disturbances in metabolism and long term end organ damage, especially the blood vessels, heart, and nerves, and severe health complications.
Individuals with T2D have reduced aerobic fitness characterized by lower peak pulmonary oxygen uptake. Many potential mechanisms could explain this impaired response, for example, reduced muscle blood flow and capillary density, defects in muscular oxygen diffusion, and lower mitochondrial oxygen utilization and function.
T2D is also associated with lower baroreflex sensitivity and abnormal chronotropic response, altering heart rate regulation. In addition, prolonged hyperglycemia in T2D causes a number of pathological changes in vascular endothelial cells, increasing the production of reactive oxygen species and inflammatory cytokines that cause mitochondrial dysfunction and oxidative damage.
- Conditions
- Diabetes Mellitus, Type 2, High-Intensity Interval Training, Exercise Training, Hyperglycaemia Due to Type 2 Diabetes Mellitus
- Being tested
- Physical training, Light-Emitting Diode (LED) therapy
- Keywords
- Cardiopulmonary Exercise Test, Rehabilitation, Diabetes Mellitus, Type 2, Functional Capacity, Photobiomodulation Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
Light-Emitting Diode (LED) therapyOther
Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).
| Study group | Role | What they receive |
|---|---|---|
| HIIT and LED therapy | Experimental | Light-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT) Receives: Other: Physical training; Other: Light-Emitting Diode (LED) therapy |
| High intensity interval training (HIIT) | Sham comparator | Light-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT) Receives: Other: Physical training; Other: Light-Emitting Diode (LED) therapy |
| Combined training and LED therapy | Experimental | Light-Emitting Diode (LED) therapy followed by physical training with combined training Receives: Other: Physical training; Other: Light-Emitting Diode (LED) therapy |
| Combined training | Sham comparator | Light-Emitting Diode (LED) therapy simulation followed by physical training with combined training. Receives: Other: Physical training; Other: Light-Emitting Diode (LED) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Oxygen consumption measurement during cardiopulmonary test
Measured: Change from Baseline to 12 weeks
Incremental shuttle walking test
Distance in meters
Measured: Change from Baseline to 12 weeks
Glycemic control
Evaluated by the percentage of glycated hemoglobin
Measured: Change from Baseline to 12 weeks
Secondary outcomes (7)
Autonomic Nervous System
Assesment by Heat Rate Variability analysis
Measured: Change from Baseline to 12 weeks
Musculoskeletal Function
Muscular strength and endurance will be evaluated by Isokinetic Dynamometry
Measured: Change from Baseline to 12 weeks
Physical Activity Questionnaire
The level of physical activity will be assessed using the international questionnaire short version physical activity (IPAQ). The continuous score allows assessing energy expenditure expressed in MET minutes/week. The IPAQ categories include: Insufficiently active (does not perform any physical activity); Sufficiently active (conducts vigorous activity at least three days a week >600 MET - 1400 MET); Very active (performs more than three days per week of vigorous activity 1500 MET - 3000 MET).
Measured: Change from Baseline to 12 weeks
Endothelial Function
Endothelial function will be assessed by arterial flow-mediated dilation (FMD)
Measured: Change from Baseline to 12 weeks
Quality of Life Questionary
Assesment by using the questionnaire Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36). The SF-36 has eight sections (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning and Mental health). The scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability and higher scores = less disability.
Measured: Change from Baseline to 12 weeks
Body mass index (BMI)
Weight and height will be combined to report BMI (kg/m2)
Measured: Change from Baseline to 12 weeks
Other Biochemical Analyzes
Total cholesterol (Total-C) (mg/dl), low-density lipoprotein cholesterol (LDL-C) (mg/dl), high-density lipoprotein cholesterol (HDL-C) (mg/dl) and triglycerides (mg/dl)
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start1 Aug 2020
- Primary completion1 Oct 2020
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
- Investigators
- Luciana MM Sampaio, Professor, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593746
- Sponsor's protocol ID
- T2Dexercise.photobiomodulation
- Status last verified
- May 2022
- First submitted
- 7 May 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bassi D, Mendes RG, Arakelian VM, Caruso FC, Cabiddu R, Junior JC, Arena R, Borghi-Silva A. Potential Effects on Cardiorespiratory and Metabolic Status After a Concurrent Strength and Endurance Training Program in Diabetes Patients - a Randomized Controlled Trial. Sports Med Open. 2016 Aug 11;2:31. doi: 10.1186/s40798-016-0052-1. eCollection 2015 Jun.
PubMed 27563535Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
PubMed 11559268Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
PubMed 23002086Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ. Effect of lifestyle intervention in patients with type 2 diabetes: a meta-analysis. Metabolism. 2015 Feb;64(2):338-47. doi: 10.1016/j.metabol.2014.10.018. Epub 2014 Oct 23.
PubMed 25467842Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.
PubMed 26258597Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.
PubMed 25717277Madsen SM, Thorup AC, Overgaard K, Bjerre M, Jeppesen PB. Functional and structural vascular adaptations following 8 weeks of low volume high intensity interval training in lower leg of type 2 diabetes patients and individuals at high risk of metabolic syndrome. Arch Physiol Biochem. 2015;121(5):178-86. doi: 10.3109/13813455.2015.1087033. Epub 2015 Oct 15.
PubMed 26471849Gibbs BB, Dobrosielski DA, Lima M, Bonekamp S, Stewart KJ, Clark JM. The association of arterial shear and flow-mediated dilation in diabetes. Vasc Med. 2011 Aug;16(4):267-74. doi: 10.1177/1358863X11411361. Epub 2011 Jun 27.
PubMed 21708874Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.
PubMed 21115771
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training and Combined Training Associated With Photobiomodulation in Type 2 Diabetic (T2D) Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03593746
- Acronym / sponsor ID
- T2Dexercise.photobiomodulation
- Conditions
- Diabetes Mellitus, Type 2, High-Intensity Interval Training, Exercise Training, Hyperglycaemia Due to Type 2 Diabetes Mellitus
- Keywords
- Cardiopulmonary Exercise Test, Rehabilitation, Diabetes Mellitus, Type 2, Functional Capacity, Photobiomodulation Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Jul 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.
Diabetes has become a widespread epidemic, primarily because of the increasing prevalence and incidence of type 2 diabetes (T2D). T2D is a significant cause of premature mortality and morbidity related to cardiovascular disease, blindness, kidney and nerve disease, and amputation.
Physical activity improves blood glucose control and can prevent or delay T2D, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life. At present, although physical activity is a key element in the prevention and management of T2D, the most effective exercise strategy (intensity, duration, and type of exercise) for improving glucose control and reducing cardiometabolic risk in type 2 diabetes has not been defined.
Studies with Light-Emitting Diode (LED) therapy have demonstrated its ability to promote pain relief, improve muscle and cardiopulmonary performance, minimize muscle fatigue, and stimulate wound healing. In relation to patients with T2D, who have prolonged conditions of hyperglycemia, studies to investigate the impact of photobiomodulation associated with physical training have not been found so far.
The objective of this study is to investigate the effects of different types of physical training associated with Light-Emitting Diode (LED) therapy on cardiometabolic status and quality of life in patients with T2D.
Detailed description
Type 2 diabetes (T2D) is a significant health problem worldwide due to its high prevalence and mortality. It is chronic metabolic disorder characterized by hyperglycemia resulting from a relative deficiency in insulin through either reduced insulin secretion or reduced insulin action or both. The subsequent chronic hyperglycaemia causes glycation of tissues, which almost inevitably leads to acute disturbances in metabolism and long term end organ damage, especially the blood vessels, heart, and nerves, and severe health complications.
Individuals with T2D have reduced aerobic fitness characterized by lower peak pulmonary oxygen uptake. Many potential mechanisms could explain this impaired response, for example, reduced muscle blood flow and capillary density, defects in muscular oxygen diffusion, and lower mitochondrial oxygen utilization and function.
T2D is also associated with lower baroreflex sensitivity and abnormal chronotropic response, altering heart rate regulation. In addition, prolonged hyperglycemia in T2D causes a number of pathological changes in vascular endothelial cells, increasing the production of reactive oxygen species and inflammatory cytokines that cause mitochondrial dysfunction and oxidative damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIIT and LED therapy | Experimental | Other: Physical training, Other: Light-Emitting Diode (LED) therapyLight-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT) |
| High intensity interval training (HIIT) | Sham comparator | Other: Physical training, Other: Light-Emitting Diode (LED) therapyLight-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT) |
| Combined training and LED therapy | Experimental | Other: Physical training, Other: Light-Emitting Diode (LED) therapyLight-Emitting Diode (LED) therapy followed by physical training with combined training |
| Combined training | Sham comparator | Other: Physical training, Other: Light-Emitting Diode (LED) therapyLight-Emitting Diode (LED) therapy simulation followed by physical training with combined training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Confirmed diagnosis of type 2 diabetes;
- Sedentary lifestyle in the last six months, according to the criteria established by the American Heart Association (AHA).
Key exclusion criteria (2 listed)
- Confirmed diagnosis of any (1) heart disease; (2) musculoskeletal disorder; (3) respiratory disease; (4) uncontrolled arterial hypertension; (5) peripheral neuropathy or (6) factors that limit the performance of any of the study evaluations and/or training.
- During the study, individuals with a presence of less than 80% in the training sessions will be excluded.
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 |
|---|---|---|
| Physical trainingType 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training). | Other | Combined training, Combined training and LED therapy, HIIT and LED therapy, High intensity interval training (HIIT) |
| Light-Emitting Diode (LED) therapyType 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham). | Other | Combined training, Combined training and LED therapy, HIIT and LED therapy, High intensity interval training (HIIT) |
Primary outcome
Functional exercise capacity
Time frame: Change from Baseline to 12 weeks
Oxygen consumption measurement during cardiopulmonary test
Incremental shuttle walking test
Time frame: Change from Baseline to 12 weeks
Distance in meters
Glycemic control
Time frame: Change from Baseline to 12 weeks
Evaluated by the percentage of glycated hemoglobin
7 secondary outcomes
Autonomic Nervous System
Time frame: Change from Baseline to 12 weeks
Musculoskeletal Function
Time frame: Change from Baseline to 12 weeks
Physical Activity Questionnaire
Time frame: Change from Baseline to 12 weeks
Endothelial Function
Time frame: Change from Baseline to 12 weeks
Quality of Life Questionary
Time frame: Change from Baseline to 12 weeks
Body mass index (BMI)
Time frame: Change from Baseline to 12 weeks
Other Biochemical Analyzes
Time frame: Change from Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 27563535Bassi D, Mendes RG, Arakelian VM, Caruso FC, Cabiddu R, Junior JC, Arena R, Borghi-Silva A. Potential Effects on Cardiorespiratory and Metabolic Status After a Concurrent Strength and Endurance Training Program in Diabetes Patients - a Randomized Controlled Trial. Sports Med Open. 2016 Aug 11;2:31. doi: 10.1186/s40798-016-0052-1. eCollection 2015 Jun.
- Background: PubMed 11559268Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
- Background: PubMed 23002086Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.
- Background: PubMed 25467842Chen L, Pei JH, Kuang J, Chen HM, Chen Z, Li ZW, Yang HZ. Effect of lifestyle intervention in patients with type 2 diabetes: a meta-analysis. Metabolism. 2015 Feb;64(2):338-47. doi: 10.1016/j.metabol.2014.10.018. Epub 2014 Oct 23.
- Background: PubMed 26258597Madsen SM, Thorup AC, Overgaard K, Jeppesen PB. High Intensity Interval Training Improves Glycaemic Control and Pancreatic beta Cell Function of Type 2 Diabetes Patients. PLoS One. 2015 Aug 10;10(8):e0133286. doi: 10.1371/journal.pone.0133286. eCollection 2015.
- Background: PubMed 25717277Francois ME, Little JP. Effectiveness and safety of high-intensity interval training in patients with type 2 diabetes. Diabetes Spectr. 2015 Jan;28(1):39-44. doi: 10.2337/diaspect.28.1.39.
- Background: PubMed 26471849Madsen SM, Thorup AC, Overgaard K, Bjerre M, Jeppesen PB. Functional and structural vascular adaptations following 8 weeks of low volume high intensity interval training in lower leg of type 2 diabetes patients and individuals at high risk of metabolic syndrome. Arch Physiol Biochem. 2015;121(5):178-86. doi: 10.3109/13813455.2015.1087033. Epub 2015 Oct 15.
- Background: PubMed 21708874Gibbs BB, Dobrosielski DA, Lima M, Bonekamp S, Stewart KJ, Clark JM. The association of arterial shear and flow-mediated dilation in diabetes. Vasc Med. 2011 Aug;16(4):267-74. doi: 10.1177/1358863X11411361. Epub 2011 Jun 27.
- Background: PubMed 21115771Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Luciana MM Sampaio, Professor principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training and Light-Emitting Diode (LED) therapy in people with Diabetes Mellitus, Type 2 and High-Intensity Interval Training, run by University of Nove de Julho 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 3 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 17 May 2022. 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 Luciana MM Sampaio, Professor (+551133859241, lucianamalosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: Change from Baseline to 12 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 NCT03593746, which also lists 9 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 2022.