AgeingGEN100NCT01666340
Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
A study testing Exercise intervention in people with Ageing, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent. Read more about this study
- Who is it for?
- Ages 70 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,567 participants
- Where
- 1 siteNorway
- Study dates
- 21 Aug 2012to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 to 76 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Born in 1936, 1937, 1938, 1939, 1940, 1941 or 1942
- Able to complete the exercise program (determined by the researchers).
Who cannot join
- Illness or disabilities that preclude exercise or hinder completion of the study
- Uncontrolled hypertension
- Symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, pulmonary hypertension, heart failure and severe arrhythmia
- Diagnosed dementia
- Cancer that makes participation impossible or exercise contraindicated. Considered individually, in consultation with the attending physician.
- Chronic communicable infectious diseases.
- Test results indicating that study participation is unsafe
- Participation in other studies conflicting with participation in Generation 100
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.
Read the detailed description
Literature lacks large controlled randomized studies that look at the effect of exercise training on morbidity and mortality. Generation 100 will be the first randomized, controlled clinical study where the primary objective is to study the effects of exercise training on morbidity and mortality in the elderly. Furthermore, the researchers will investigate whether there is a relationship between the exercise intensity and health benefits, with particular focus on major health problems in the elderly population. In addition to being a study, this is also an initiative to improve public health in all healthy individuals between 70-75 years of age in the Trondheim municipality. The participants will either be randomized to supervised exercise or follow current guidelines for physical activity on their own. Clinical examinations, as well as questionnaires, will be administered to all participants at baseline, after one year, after three years, and after five years. Additionally, participants will be followed-up by linking to relevant registers for up to 20 years.
Also data will be collected with the purposes of (a) investigating genetic predisposition for fitness and cardiovascular diseases, and (b) identification of potential targets for therapies.
The study seeks to determine if exercise training gives the seniors a longer active and healthy life.
- Conditions
- Ageing
- Being tested
- Exercise intervention
- Keywords
- Exercise, Elderly, Mortality, Morbidity, Prognosis, Longevity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionOther
Also called Moderate training
Group asked to perform exercise at a given moderate intensity for a set time
Exercise interventionOther
Also called High intensity
High intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| high intensity aerobic training | Experimental | Exercise intervention: High intensity group performing high intensity training where they are required to raise their heart rate several times during the workout and reach perceived exhaustion of 16 on a Borg scale Receives: Other: Exercise intervention |
| Moderate intensity training | Other | Exercise intervention: Moderate intensity Group of people asked to perform moderate training where they exercise at a given intensity (moderate as per Borg scale) for a certain amount of time Receives: Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
using data from governmental registers
Measured: 5 years follow up
Secondary outcomes (4)
General measurements
resting blood pressure, resting fasting blood sample, resting heart rate, weight, height and waistline, body composition (muscle vs fat) questionnaires (activity, safety, monthly training diary) walking test, grip strength test, leg strength test, pulmonary function, physical activity level
Measured: 1 year follow up, 3 years follow up, 5 years follow up
Epigenetics
transcriptomics (messenger RNAs and microRNAs) and proteomics arrays, aimed at blood-borne factors induced by training.
Measured: 1 year follow up, 3 years follow up, 5 years follow up
Morbidity
Look at morbidity after 3 and 5 years follow up(i.e. cardiovascular disease, cancer, etc.) using medical records and link to the different health registers.
Measured: 3 and 5 years
Mortality and Morbidity
Look at morbidity after 10 year follow-up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study start21 Aug 2012
- Primary completionJun 2018
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AgeingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, Professor, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666340
- Sponsor's protocol ID
- Generation-100
- Acronym
- GEN100
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2012
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stensvold D, Viken H, Rognmo O, Skogvoll E, Steinshamn S, Vatten LJ, Coombes JS, Anderssen SA, Magnussen J, Ingebrigtsen JE, Fiatarone Singh MA, Langhammer A, Stoylen A, Helbostad JL, Wisloff U. A randomised controlled study of the long-term effects of exercise training on mortality in elderly people: study protocol for the Generation 100 study. BMJ Open. 2015 Feb 12;5(2):e007519. doi: 10.1136/bmjopen-2014-007519.
PubMed 25678546Viken H, Reitlo LS, Zisko N, Nauman J, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. Predictors of Dropout in Exercise Trials in Older Adults: The Generation 100 Study. Med Sci Sports Exerc. 2019 Jan;51(1):49-55. doi: 10.1249/MSS.0000000000001742.
PubMed 30113524Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbostad JL, Rognmo O, Wisloff U. Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial. BMJ. 2020 Oct 7;371:m3485. doi: 10.1136/bmj.m3485.
PubMed 33028588Letnes JM, Berglund I, Johnson KE, Dalen H, Nes BM, Lydersen S, Viken H, Hassel E, Steinshamn S, Vesterbekkmo EK, Stoylen A, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Ingebrigtsen JE, Sandbakk SB, Carlsen T, Anderssen SA, Singh MAF, Coombes JS, Helbostad JL, Rognmo O, Wisloff U, Stensvold D. Effect of 5 years of exercise training on the cardiovascular risk profile of older adults: the Generation 100 randomized trial. Eur Heart J. 2022 Jun 1;43(21):2065-2075. doi: 10.1093/eurheartj/ehab721.
PubMed 34746955Brissach DE, Berg HH, Stensvold D, Ingestrom EML, Walker TL, Laukkanen JA, Vasankari T, Sando SB, Tari AR, Wisloff U. Objectively Measured Cardiorespiratory Fitness as a Potential Biomarker for Alzheimer Disease Risk in Older Adults: Evidence from the Generation 100 Study. Med Sci Sports Exerc. 2026 Nov 1;58(11):2423-2432. doi: 10.1249/MSS.0000000000004064. Epub 2026 Jul 3.
PubMed 42390354Reitlo LS, Pani J, Stensvold D, Wisloff U, Haberg AK. Long-Term Effects of a 5-Year Randomized Controlled Exercise Trial on Brain Volumes and Cognitive Function in Older Adults: A 4-Year Post-Intervention Follow-Up Study. Sports Med. 2026 Aug;56(8):2029-2045. doi: 10.1007/s40279-026-02434-3. Epub 2026 Apr 18.
PubMed 41999477Stene GB, Lequerica MJ, Stensvold D, Balstad TR, Lydersen S, Wisloff U, Helbostad JL. Effects of 5 Years of Aerobic Exercise on Sarcopenia in Older Adults-Secondary Outcomes of the Generation 100 Study. J Cachexia Sarcopenia Muscle. 2026 Apr;17(2):e70279. doi: 10.1002/jcsm.70279.
PubMed 41936539Bakken J, Brissach DE, Ingestrom EML, Midttun S, Walker TL, Stensvold D, Tari AR. Effects of 5-Year Exercise Training on Cognition in Older Adults: 10-Years Follow-Up from the Generation 100 Study. Sports Med Open. 2025 Dec 7;11(1):153. doi: 10.1186/s40798-025-00956-0.
PubMed 41354893LE AN, Lydersen S, Brissach DE, Haberg AK, Walker TL, Schaumberg M, Berg HH, Stensvold D, Tari AR. Longitudinal Associations between Cardiorespiratory Fitness and Cognition in Older Adults: A 10-Year Follow-Up from the Generation 100 Study. Med Sci Sports Exerc. 2026 Apr 1;58(4):704-712. doi: 10.1249/MSS.0000000000003903. Epub 2026 Mar 5.
PubMed 41330544Hallan SI, Ovrehus MA, Shlipak MG, Potok OA, Romundstad S, Aspvik NP, Wisloff U, Ix JH, Stensvold D, Langlo KA. Long-Term Physical Exercise for Preventing CKD in Older Adults: A Randomized Clinical Trial. J Am Soc Nephrol. 2025 Feb 11;36(7):1352-1362. doi: 10.1681/ASN.0000000636.
PubMed 39932787Tari AR, Brissach DE, Ingestrom EML, Nauman J, Tyrell T, Foster C, Radtke K, Porcari JP, Lydersen S, Kaminsky LA, Myers J, Walker TL, Coombes JS, Stensvold D, Wisloff U. Survival of the fittest? Peak oxygen uptake and all-cause mortality among older adults in Norway. Prog Cardiovasc Dis. 2025 Mar-Apr;89:25-34. doi: 10.1016/j.pcad.2024.11.004. Epub 2024 Dec 4.
PubMed 39638222Reitlo LS, Mihailovic JM, Stensvold D, Wisloff U, Hyder F, Haberg AK. Hippocampal neurochemicals are associated with exercise group and intensity, psychological health, and general cognition in older adults. Geroscience. 2023 Jun;45(3):1667-1685. doi: 10.1007/s11357-022-00719-9. Epub 2023 Jan 10.
PubMed 36626020Zotcheva E, Haberg AK, Wisloff U, Salvesen O, Selbaek G, Stensvold D, Ernstsen L. Effects of 5 Years Aerobic Exercise on Cognition in Older Adults: The Generation 100 Study: A Randomized Controlled Trial. Sports Med. 2022 Jul;52(7):1689-1699. doi: 10.1007/s40279-021-01608-5. Epub 2021 Dec 8.
PubMed 34878637Sokolowski DR, Hansen TI, Rise HH, Reitlo LS, Wisloff U, Stensvold D, Haberg AK. 5 Years of Exercise Intervention Did Not Benefit Cognition Compared to the Physical Activity Guidelines in Older Adults, but Higher Cardiorespiratory Fitness Did. A Generation 100 Substudy. Front Aging Neurosci. 2021 Nov 16;13:742587. doi: 10.3389/fnagi.2021.742587. eCollection 2021.
PubMed 34867275Berglund I, Vesterbekkmo EK, Retterstol K, Anderssen SA, Fiatarone Singh MA, Helge JW, Lydersen S, Wisloff U, Stensvold D. The Long-term Effect of Different Exercise Intensities on High-Density Lipoprotein Cholesterol in Older Men and Women Using the Per Protocol Approach: The Generation 100 Study. Mayo Clin Proc Innov Qual Outcomes. 2021 Sep 16;5(5):859-871. doi: 10.1016/j.mayocpiqo.2021.07.002. eCollection 2021 Oct.
PubMed 34585083
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT01666340
- Acronym / sponsor ID
- GEN100 / Generation-100
- Conditions
- Ageing
- Keywords
- Exercise, Elderly, Mortality, Morbidity, Prognosis, Longevity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,567 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Aug 2012 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Aug 2012 (estimated)
- 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.
Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.
Detailed description
Literature lacks large controlled randomized studies that look at the effect of exercise training on morbidity and mortality. Generation 100 will be the first randomized, controlled clinical study where the primary objective is to study the effects of exercise training on morbidity and mortality in the elderly. Furthermore, the researchers will investigate whether there is a relationship between the exercise intensity and health benefits, with particular focus on major health problems in the elderly population. In addition to being a study, this is also an initiative to improve public health in all healthy individuals between 70-75 years of age in the Trondheim municipality. The participants will either be randomized to supervised exercise or follow current guidelines for physical activity on their own. Clinical examinations, as well as questionnaires, will be administered to all participants at baseline, after one year, after three years, and after five years. Additionally, participants will be followed-up by linking to relevant registers for up to 20 years.
Also data will be collected with the purposes of (a) investigating genetic predisposition for fitness and cardiovascular diseases, and (b) identification of potential targets for therapies.
The study seeks to determine if exercise training gives the seniors a longer active and healthy life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high intensity aerobic training | Experimental | Other: Exercise interventionExercise intervention: High intensity group performing high intensity training where they are required to raise their heart rate several times during the workout and reach perceived exhaustion of 16 on a Borg scale |
| Moderate intensity training | Other | Other: Exercise interventionExercise intervention: Moderate intensity Group of people asked to perform moderate training where they exercise at a given intensity (moderate as per Borg scale) for a certain amount of time |
Who may qualify
- Ages
- 70 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Born in 1936, 1937, 1938, 1939, 1940, 1941 or 1942
- Able to complete the exercise program (determined by the researchers).
Key exclusion criteria (8 listed)
- Illness or disabilities that preclude exercise or hinder completion of the study
- Uncontrolled hypertension
- Symptomatic valvular, hypertrophic cardiomyopathy, unstable angina, pulmonary hypertension, heart failure and severe arrhythmia
- Diagnosed dementia
- Cancer that makes participation impossible or exercise contraindicated. Considered individually, in consultation with the attending physician.
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 |
|---|---|---|
| Exercise interventionAlso: Moderate trainingGroup asked to perform exercise at a given moderate intensity for a set time | Other | Moderate intensity training, high intensity aerobic training |
| Exercise interventionAlso: High intensityHigh intensity exercise | Other | Moderate intensity training, high intensity aerobic training |
Primary outcome
Mortality
Time frame: 5 years follow up
using data from governmental registers
4 secondary outcomes
General measurements
Time frame: 1 year follow up, 3 years follow up, 5 years follow up
Epigenetics
Time frame: 1 year follow up, 3 years follow up, 5 years follow up
Morbidity
Time frame: 3 and 5 years
Mortality and Morbidity
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 25678546Stensvold D, Viken H, Rognmo O, Skogvoll E, Steinshamn S, Vatten LJ, Coombes JS, Anderssen SA, Magnussen J, Ingebrigtsen JE, Fiatarone Singh MA, Langhammer A, Stoylen A, Helbostad JL, Wisloff U. A randomised controlled study of the long-term effects of exercise training on mortality in elderly people: study protocol for the Generation 100 study. BMJ Open. 2015 Feb 12;5(2):e007519. doi: 10.1136/bmjopen-2014-007519.
- Background: PubMed 30113524Viken H, Reitlo LS, Zisko N, Nauman J, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. Predictors of Dropout in Exercise Trials in Older Adults: The Generation 100 Study. Med Sci Sports Exerc. 2019 Jan;51(1):49-55. doi: 10.1249/MSS.0000000000001742.
- Results publication: PubMed 33028588Stensvold D, Viken H, Steinshamn SL, Dalen H, Stoylen A, Loennechen JP, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Sandbakk SB, Carlsen T, Ingebrigtsen JE, Lydersen S, Mattsson E, Anderssen SA, Fiatarone Singh MA, Coombes JS, Skogvoll E, Vatten LJ, Helbostad JL, Rognmo O, Wisloff U. Effect of exercise training for five years on all cause mortality in older adults-the Generation 100 study: randomised controlled trial. BMJ. 2020 Oct 7;371:m3485. doi: 10.1136/bmj.m3485.
- Results publication: PubMed 34746955Letnes JM, Berglund I, Johnson KE, Dalen H, Nes BM, Lydersen S, Viken H, Hassel E, Steinshamn S, Vesterbekkmo EK, Stoylen A, Reitlo LS, Zisko N, Baekkerud FH, Tari AR, Ingebrigtsen JE, Sandbakk SB, Carlsen T, Anderssen SA, Singh MAF, Coombes JS, Helbostad JL, Rognmo O, Wisloff U, Stensvold D. Effect of 5 years of exercise training on the cardiovascular risk profile of older adults: the Generation 100 randomized trial. Eur Heart J. 2022 Jun 1;43(21):2065-2075. doi: 10.1093/eurheartj/ehab721.
- Derived from this study: PubMed 42390354Brissach DE, Berg HH, Stensvold D, Ingestrom EML, Walker TL, Laukkanen JA, Vasankari T, Sando SB, Tari AR, Wisloff U. Objectively Measured Cardiorespiratory Fitness as a Potential Biomarker for Alzheimer Disease Risk in Older Adults: Evidence from the Generation 100 Study. Med Sci Sports Exerc. 2026 Nov 1;58(11):2423-2432. doi: 10.1249/MSS.0000000000004064. Epub 2026 Jul 3.
- Derived from this study: PubMed 41999477Reitlo LS, Pani J, Stensvold D, Wisloff U, Haberg AK. Long-Term Effects of a 5-Year Randomized Controlled Exercise Trial on Brain Volumes and Cognitive Function in Older Adults: A 4-Year Post-Intervention Follow-Up Study. Sports Med. 2026 Aug;56(8):2029-2045. doi: 10.1007/s40279-026-02434-3. Epub 2026 Apr 18.
- Derived from this study: PubMed 41936539Stene GB, Lequerica MJ, Stensvold D, Balstad TR, Lydersen S, Wisloff U, Helbostad JL. Effects of 5 Years of Aerobic Exercise on Sarcopenia in Older Adults-Secondary Outcomes of the Generation 100 Study. J Cachexia Sarcopenia Muscle. 2026 Apr;17(2):e70279. doi: 10.1002/jcsm.70279.
- Derived from this study: PubMed 41354893Bakken J, Brissach DE, Ingestrom EML, Midttun S, Walker TL, Stensvold D, Tari AR. Effects of 5-Year Exercise Training on Cognition in Older Adults: 10-Years Follow-Up from the Generation 100 Study. Sports Med Open. 2025 Dec 7;11(1):153. doi: 10.1186/s40798-025-00956-0.
- Derived from this study: PubMed 41330544LE AN, Lydersen S, Brissach DE, Haberg AK, Walker TL, Schaumberg M, Berg HH, Stensvold D, Tari AR. Longitudinal Associations between Cardiorespiratory Fitness and Cognition in Older Adults: A 10-Year Follow-Up from the Generation 100 Study. Med Sci Sports Exerc. 2026 Apr 1;58(4):704-712. doi: 10.1249/MSS.0000000000003903. Epub 2026 Mar 5.
- Derived from this study: PubMed 39932787Hallan SI, Ovrehus MA, Shlipak MG, Potok OA, Romundstad S, Aspvik NP, Wisloff U, Ix JH, Stensvold D, Langlo KA. Long-Term Physical Exercise for Preventing CKD in Older Adults: A Randomized Clinical Trial. J Am Soc Nephrol. 2025 Feb 11;36(7):1352-1362. doi: 10.1681/ASN.0000000636.
- Derived from this study: PubMed 39638222Tari AR, Brissach DE, Ingestrom EML, Nauman J, Tyrell T, Foster C, Radtke K, Porcari JP, Lydersen S, Kaminsky LA, Myers J, Walker TL, Coombes JS, Stensvold D, Wisloff U. Survival of the fittest? Peak oxygen uptake and all-cause mortality among older adults in Norway. Prog Cardiovasc Dis. 2025 Mar-Apr;89:25-34. doi: 10.1016/j.pcad.2024.11.004. Epub 2024 Dec 4.
- Derived from this study: PubMed 36626020Reitlo LS, Mihailovic JM, Stensvold D, Wisloff U, Hyder F, Haberg AK. Hippocampal neurochemicals are associated with exercise group and intensity, psychological health, and general cognition in older adults. Geroscience. 2023 Jun;45(3):1667-1685. doi: 10.1007/s11357-022-00719-9. Epub 2023 Jan 10.
- Generation 100 web pageLink provided by the sponsor.
- Results published in BMJ Oct 2020Link provided by the sponsor.
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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.
Ulrik Wisløff, Professor study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Ageing, run by Norwegian University of Science and Technology at 1 site in Norway.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality (time frame: 5 years follow up). 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 NCT01666340, which also lists 15 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 15 Sep 2025.