Amyotrophic Lateral SclerosisNCT03326622
Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients
A study testing moderate exercise in people with Amyotrophic Lateral Sclerosis, run by University of Lisbon.
Trial summary
This study evaluated the influence of a tailored aerobic exercise protocol on the functional outcome in ALS patients. In addition, the investigators compare some CPET variables collected during exercise testing in both groups. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- moderate exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 30 Jun 2015
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients diagnosed with definite, probable, or probable laboratory supported ALS
- Disease duration from first symptoms between 6-24 months to exclude slow and fast progression
- ALSFRS-R ≥ 30
- FVC (%predicted) ≥ 70%
Who cannot join
- Other medical conditions, like cardiac insufficiency and lung disorders or others conditions limiting exercise training;
- Heavy smoking habits with laboratorial evidence of significant bronchial constriction;
- Signs of associated dementia or psychiatric disorders.
- Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).
About this study
Official title: The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS
This study evaluated the influence of a tailored aerobic exercise protocol on the functional outcome in ALS patients. In addition, the investigators compare some CPET variables collected during exercise testing in both groups.
Read the detailed description
This work aimed to evaluate the effects of a moderate aerobic exercise with controlled intensity determined by Cardiopulmonary Exercise Testing (CPET) and its role on the functional status in ALS patients versus standard care. Additionally, the investigators explored the performance of CPET variables - oxygen uptake (VO2) expressed in L/min, in percentage of predicted or in metabolic equivalents (METs) at peak effort, at anaerobic threshold (AT), the respiratory compensation point (RCP) when achieved, Dioxide Carbon output in L/min (VCO2) and the minute ventilation in L/min (VE) throughout the study.
Assessments:(diagnostic visit - T0), at study entry (T1) and 6 months after (T2) using:
Functional status by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Respiratory function tests (RFT): Forced Vital Capacity predicted (%FVC) and Oxygen saturation provided by pulse oximetry.
CPET was performed in both groups at study entry and 6 months later (T1 and T2), using a treadmill (WOODWAY®) coupled with a gas exchange analyzer (METALYZER® 3B) with ergo-spirometry system using a breath-by-breath technology developed by CORTEX® systems.
Intervention:
G1(Interventional group) performed moderate exercise protocol two times/week in a treadmill in the lower range of the training zone determined by CPET + standard care (range of motion exercise, gait and balance training under continuous pulse oximetry observation).
G2 (control group) performed a standard care exercise program at home or at other rehabilitation units without pulse oximetry observation.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- standard care, moderate exercise
- Keywords
- Amyotrophic Lateral Sclerosis, aerobic exercise, functional outcome, non-invasive ventilation, oxygen uptake
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careOther
Also called Range of Motion, Gait Training, Balance training
A standard care program based on American Academy of Neurology guidelines (Range Of Motion (ROM) exercises, gait and balance training )at home or another rehabilitation units without intensity control.
moderate exerciseOther
A moderate exercise protocol two times per week in a treadmill in the lower range of the training zone determined by Cardiopulmonary Exercise Testing, monitored by continuous pulse oximetry evaluation.
| Study group | Role | What they receive |
|---|---|---|
| moderate exercise + standard care | Experimental | This group performed a moderate exercise protocol with training zone determined by Cardiopulmonary Exercise testing added to standard care program based on American Academy of Neurology guidelines. Receives: Other: standard care; Other: moderate exercise |
| Standard care | Active comparator | This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control. Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional decline between start and end of the study
It was used the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R),which rates the functionality of the ALS patients in performing activities involving 4 different areas through 3 sub-scores - bulbar, spinal [upper and lower limb] and also the respiratory function. Each of its questions is rated from 0 (total inability) to 4 points (no functional limitation). The last three questions address the respiratory function (dyspnea, orthopnea, respiratory insufficiency) and assess the respiratory functional outcome.
The sub-scores rating: Bulbar sub-score between 0 - 12, the spinal score between 0 - 24 and the respiratory sub-score between 0 - 12.The sum of the sub-scores provide an ALSFRS-R total score = 48. Higher values represent a better functionality.
Measured: between baseline and 6 months later
Secondary outcomes (3)
Performance of Cardiopulmonary Exercise testing variables throughout the study
Changes on the oxygen uptake (VO2peak) measurement following an aerobic exercise protocol compared to standard care.
Measured: at study entry and 6 months later.
Changes on the Dioxide Carbon output (VCO2) measurement
Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.
Measured: at study entry and 6 months later
Changes on the Minute Ventilation (VE) measurement
Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care.
Measured: at study entry and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jul 2013
- Primary completion30 Mar 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Caroline Braga, University of Lisbon
- Investigators
- Mamede de Carvalho, MD PhD, Study director, Institute of Molecular MedicineAnabela Pinto, MD PhD, Principal investigator, Institute of Molecular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326622
- Sponsor's protocol ID
- FCT - SFRH/BD/78413/2011
- Status last verified
- Oct 2017
- First submitted
- 21 Oct 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization - Physical activity Fact Sheet nº385. In www.who.int/mediacentre/factsheets/fs385/en/ January; 2015
Mahoney DJ, Rodriguez C, Devries M, Yasuda N, Tarnopolsky MA. Effects of high-intensity endurance exercise training in the G93A mouse model of amyotrophic lateral sclerosis. Muscle Nerve. 2004 May;29(5):656-62. doi: 10.1002/mus.20004.
PubMed 15116368Pinto S, Swash M, de Carvalho M. Respiratory exercise in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012 Jan;13(1):33-43. doi: 10.3109/17482968.2011.626052.
PubMed 22214352Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
PubMed 20585013Binder RK, Wonisch M, Corra U, Cohen-Solal A, Vanhees L, Saner H, Schmid JP. Methodological approach to the first and second lactate threshold in incremental cardiopulmonary exercise testing. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):726-34. doi: 10.1097/HJR.0b013e328304fed4.
PubMed 19050438Majmudar S, Wu J, Paganoni S. Rehabilitation in amyotrophic lateral sclerosis: why it matters. Muscle Nerve. 2014 Jul;50(1):4-13. doi: 10.1002/mus.24202. Epub 2014 May 17.
PubMed 24510737Cup EH, Pieterse AJ, Ten Broek-Pastoor JM, Munneke M, van Engelen BG, Hendricks HT, van der Wilt GJ, Oostendorp RA. Exercise therapy and other types of physical therapy for patients with neuromuscular diseases: a systematic review. Arch Phys Med Rehabil. 2007 Nov;88(11):1452-64. doi: 10.1016/j.apmr.2007.07.024.
PubMed 17964887Beal MF. Does impairment of energy metabolism result in excitotoxic neuronal death in neurodegenerative illnesses? Ann Neurol. 1992 Feb;31(2):119-30. doi: 10.1002/ana.410310202.
PubMed 1349466Miller RG, Jackson CE, Kasarskis EJ, England JD, Forshew D, Johnston W, Kalra S, Katz JS, Mitsumoto H, Rosenfeld J, Shoesmith C, Strong MJ, Woolley SC; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009 Oct 13;73(15):1218-26. doi: 10.1212/WNL.0b013e3181bc0141.
PubMed 19822872Pinto AC, Evangelista T, Carvalho M, Alves MA, Sales Luis ML. Respiratory assistance with a non-invasive ventilator (Bipap) in MND/ALS patients: survival rates in a controlled trial. J Neurol Sci. 1995 May;129 Suppl:19-26. doi: 10.1016/0022-510x(95)00052-4.
PubMed 7595610Bourke SC, Tomlinson M, Williams TL, Bullock RE, Shaw PJ, Gibson GJ. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. 2006 Feb;5(2):140-7. doi: 10.1016/S1474-4422(05)70326-4.
PubMed 16426990Chetta A, Aiello M, Tzani P, Olivieri D. Assessment and monitoring of ventilatory function and cough efficacy in patients with amyotrophic lateral sclerosis. Monaldi Arch Chest Dis. 2007 Mar;67(1):43-52. doi: 10.4081/monaldi.2007.509.
PubMed 17564284Motor Neurone Disease: The Use of Non-Invasive Ventilation in the Management of Motor Neurone Disease [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2010 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK65383/
PubMed 22171400Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.
PubMed 10540002Pinto A, de Carvalho M, Evangelista T, Lopes A, Sales-Luis L. Nocturnal pulse oximetry: a new approach to establish the appropriate time for non-invasive ventilation in ALS patients. Amyotroph Lateral Scler Other Motor Neuron Disord. 2003 Apr;4(1):31-5. doi: 10.1080/14660820310006706.
PubMed 12745616
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS
- ClinicalTrials.gov ID
- NCT03326622
- Acronym / sponsor ID
- FCT - SFRH/BD/78413/2011
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, aerobic exercise, functional outcome, non-invasive ventilation, oxygen uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Mar 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 31 Oct 2017 (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 evaluated the influence of a tailored aerobic exercise protocol on the functional outcome in ALS patients. In addition, the investigators compare some CPET variables collected during exercise testing in both groups.
Detailed description
This work aimed to evaluate the effects of a moderate aerobic exercise with controlled intensity determined by Cardiopulmonary Exercise Testing (CPET) and its role on the functional status in ALS patients versus standard care. Additionally, the investigators explored the performance of CPET variables - oxygen uptake (VO2) expressed in L/min, in percentage of predicted or in metabolic equivalents (METs) at peak effort, at anaerobic threshold (AT), the respiratory compensation point (RCP) when achieved, Dioxide Carbon output in L/min (VCO2) and the minute ventilation in L/min (VE) throughout the study.
Assessments:(diagnostic visit - T0), at study entry (T1) and 6 months after (T2) using:
Functional status by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Respiratory function tests (RFT): Forced Vital Capacity predicted (%FVC) and Oxygen saturation provided by pulse oximetry.
CPET was performed in both groups at study entry and 6 months later (T1 and T2), using a treadmill (WOODWAY®) coupled with a gas exchange analyzer (METALYZER® 3B) with ergo-spirometry system using a breath-by-breath technology developed by CORTEX® systems.
Intervention:
G1(Interventional group) performed moderate exercise protocol two times/week in a treadmill in the lower range of the training zone determined by CPET + standard care (range of motion exercise, gait and balance training under continuous pulse oximetry observation).
G2 (control group) performed a standard care exercise program at home or at other rehabilitation units without pulse oximetry observation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate exercise + standard care | Experimental | Other: standard care, Other: moderate exerciseThis group performed a moderate exercise protocol with training zone determined by Cardiopulmonary Exercise testing added to standard care program based on American Academy of Neurology guidelines. |
| Standard care | Active comparator | Other: standard careThis group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consecutive patients diagnosed with definite, probable, or probable laboratory supported ALS
- Disease duration from first symptoms between 6-24 months to exclude slow and fast progression
- ALSFRS-R ≥ 30
- FVC (%predicted) ≥ 70%
Key exclusion criteria (4 listed)
- Other medical conditions, like cardiac insufficiency and lung disorders or others conditions limiting exercise training;
- Heavy smoking habits with laboratorial evidence of significant bronchial constriction;
- Signs of associated dementia or psychiatric disorders.
- Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).
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 |
|---|---|---|
| standard careAlso: Range of Motion, Gait Training, Balance trainingA standard care program based on American Academy of Neurology guidelines (Range Of Motion (ROM) exercises, gait and balance training )at home or another rehabilitation units without intensity control. | Other | Standard care, moderate exercise + standard care |
| moderate exerciseA moderate exercise protocol two times per week in a treadmill in the lower range of the training zone determined by Cardiopulmonary Exercise Testing, monitored by continuous pulse oximetry evaluation. | Other | moderate exercise + standard care |
Primary outcome
Functional decline between start and end of the study
Time frame: between baseline and 6 months later
It was used the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R),which rates the functionality of the ALS patients in performing activities involving 4 different areas through 3 sub-scores - bulbar, spinal [upper and lower limb] and also the respiratory function. Each of its questions is rated from 0 (total inability) to 4 points (no functional limitation). The last three questions address the respiratory function (dyspnea, orthopnea, respiratory insufficiency) and assess the respiratory functional outcome. The sub-scores rating: Bulbar sub-score between 0 - 12, the spinal score between 0 - 24 and the respiratory sub-score between 0 - 12.The sum of the sub-scores provide an ALSFRS-R total score = 48. Higher values represent a better functionality.
3 secondary outcomes
Performance of Cardiopulmonary Exercise testing variables throughout the study
Time frame: at study entry and 6 months later.
Changes on the Dioxide Carbon output (VCO2) measurement
Time frame: at study entry and 6 months later
Changes on the Minute Ventilation (VE) measurement
Time frame: at study entry and 6 months later
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 1 Nov 2017.
- BackgroundWorld Health Organization - Physical activity Fact Sheet nº385. In www.who.int/mediacentre/factsheets/fs385/en/ January; 2015
- Background: PubMed 15116368Mahoney DJ, Rodriguez C, Devries M, Yasuda N, Tarnopolsky MA. Effects of high-intensity endurance exercise training in the G93A mouse model of amyotrophic lateral sclerosis. Muscle Nerve. 2004 May;29(5):656-62. doi: 10.1002/mus.20004.
- Background: PubMed 22214352Pinto S, Swash M, de Carvalho M. Respiratory exercise in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012 Jan;13(1):33-43. doi: 10.3109/17482968.2011.626052.
- Background: PubMed 20585013Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
- Background: PubMed 19050438Binder RK, Wonisch M, Corra U, Cohen-Solal A, Vanhees L, Saner H, Schmid JP. Methodological approach to the first and second lactate threshold in incremental cardiopulmonary exercise testing. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):726-34. doi: 10.1097/HJR.0b013e328304fed4.
- Background: PubMed 24510737Majmudar S, Wu J, Paganoni S. Rehabilitation in amyotrophic lateral sclerosis: why it matters. Muscle Nerve. 2014 Jul;50(1):4-13. doi: 10.1002/mus.24202. Epub 2014 May 17.
- Background: PubMed 17964887Cup EH, Pieterse AJ, Ten Broek-Pastoor JM, Munneke M, van Engelen BG, Hendricks HT, van der Wilt GJ, Oostendorp RA. Exercise therapy and other types of physical therapy for patients with neuromuscular diseases: a systematic review. Arch Phys Med Rehabil. 2007 Nov;88(11):1452-64. doi: 10.1016/j.apmr.2007.07.024.
- Background: PubMed 1349466Beal MF. Does impairment of energy metabolism result in excitotoxic neuronal death in neurodegenerative illnesses? Ann Neurol. 1992 Feb;31(2):119-30. doi: 10.1002/ana.410310202.
- Background: PubMed 19822872Miller RG, Jackson CE, Kasarskis EJ, England JD, Forshew D, Johnston W, Kalra S, Katz JS, Mitsumoto H, Rosenfeld J, Shoesmith C, Strong MJ, Woolley SC; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009 Oct 13;73(15):1218-26. doi: 10.1212/WNL.0b013e3181bc0141.
- Background: PubMed 7595610Pinto AC, Evangelista T, Carvalho M, Alves MA, Sales Luis ML. Respiratory assistance with a non-invasive ventilator (Bipap) in MND/ALS patients: survival rates in a controlled trial. J Neurol Sci. 1995 May;129 Suppl:19-26. doi: 10.1016/0022-510x(95)00052-4.
- Background: PubMed 16426990Bourke SC, Tomlinson M, Williams TL, Bullock RE, Shaw PJ, Gibson GJ. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. 2006 Feb;5(2):140-7. doi: 10.1016/S1474-4422(05)70326-4.
- Background: PubMed 17564284Chetta A, Aiello M, Tzani P, Olivieri D. Assessment and monitoring of ventilatory function and cough efficacy in patients with amyotrophic lateral sclerosis. Monaldi Arch Chest Dis. 2007 Mar;67(1):43-52. doi: 10.4081/monaldi.2007.509.
- 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.
Mamede de Carvalho, MD PhD study director
Institute of Molecular Medicine
Anabela Pinto, MD PhD principal investigator
Institute of Molecular Medicine
Questions about this trial
What is this clinical trial studying?
A study testing moderate exercise in people with Amyotrophic Lateral Sclerosis, run by University of Lisbon.
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 4 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: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional decline between start and end of the study (time frame: between baseline and 6 months later). 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 NCT03326622, which also lists 35 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 1 Nov 2017.