AgingNCT02779972
Age Related Changes in Cardiac Physiology as a Predictor of Exercise Tolerance
An observational study of Aging and Exercise Tolerance, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Aging is associated with numerous changes and adaptations in the cardiovascular system. Vascular and ventricular wall thickness increase, whereas arterial compliance, endothelial function, and ventricular contractility decline. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Exercise Tolerance
- What is being tested?
- Echo stress test
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2016to 4 Feb 2018
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients above 65 with preserved systolic function and stress echo on a treadmill between 1 Jan 2012 until 31 Dec 2015 in our facility
Who may be able to join
- All patients above 65 with preserved systolic function and stress echo on a treadmill between 1 Jan 2012 until 31 Dec 2015 in the facility.
Who cannot join
- Missing complete information used for data collection.
Trial locations and contacts
1 site in 1 country.
About this study
Aging is associated with numerous changes and adaptations in the cardiovascular system. Vascular and ventricular wall thickness increase, whereas arterial compliance, endothelial function, and ventricular contractility decline. The decline in cardiac function with advancing age is typically seen in parallel to reduced physical activity, and it has been proposed that lifelong exercise training might attenuate the effects of aging on the heart.
The cardiovascular system undergoes several age-related changes. For most healthy older individuals, the heart generally functions well under resting conditions. Structural and physiological changes tend to result in diminished exercise tolerance. However, increasingly it has been shown that even some of these changes are more a result of a sedentary lifestyle than an age-related phenomenon. Most elderly people tend to become less physically active. It is difficult to separate changes intrinsic to the aging process from those arising as a result of a sedentary lifestyle.
Read the detailed description
Previous large studies have concluded that resting LV diastolic and systolic function decline with age. The cardiovascular system undergoes several age-related changes. For most healthy older individuals, the heart generally functions well under resting conditions. Structural and physiological changes tend to result in diminished exercise tolerance. However, increasingly it has been shown that even some of these changes are more a result of a sedentary lifestyle than an age-related phenomenon. Most elderly people tend to become less physically active. It is difficult to separate changes intrinsic to the aging process from those arising as a result of a sedentary lifestyle. Studies of aging and physical activity usually compare older athletes with sedentary ones, in which physical activity was not found to attenuate the impact on the aging heart. Thus, the investigators set of to find the difference between hearts of elderly who are physically fit as measured with METS to those who are not. And try and understand the basis of this difference.
- Conditions
- Aging, Exercise Tolerance
- Being tested
- Echo stress test
- Keywords
- Cardiac Physiology, Physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo stress testOther
Echo stress test
| Study group | Role | What they receive |
|---|---|---|
| 60's decade | 60's decade Echo stress test Receives: Other: Echo stress test | |
| 70's decade | 70's decade Echo stress test Receives: Other: Echo stress test | |
| 80's decade | 80's decade Echo stress test Receives: Other: Echo stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output at maximal stress test
mean cardiac output in liter per minute for each age group
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Jan 2018
- Study completion4 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Ehud Chorin, MD, Principal investigator, 972-3-6947520
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779972
- Sponsor's protocol ID
- TASMC-16-UC-0090-16-TLV-CTIL
- Status last verified
- Feb 2018
- First submitted
- 17 May 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Related Changes in Cardiac Physiology as a Predictor of Exercise Tolerance
- ClinicalTrials.gov ID
- NCT02779972
- Acronym / sponsor ID
- TASMC-16-UC-0090-16-TLV-CTIL
- Conditions
- Aging, Exercise Tolerance
- Keywords
- Cardiac Physiology, Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 4 Feb 2018 (actual)
- First posted
- 23 May 2016 (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.
Aging is associated with numerous changes and adaptations in the cardiovascular system. Vascular and ventricular wall thickness increase, whereas arterial compliance, endothelial function, and ventricular contractility decline. The decline in cardiac function with advancing age is typically seen in parallel to reduced physical activity, and it has been proposed that lifelong exercise training might attenuate the effects of aging on the heart.
The cardiovascular system undergoes several age-related changes. For most healthy older individuals, the heart generally functions well under resting conditions. Structural and physiological changes tend to result in diminished exercise tolerance. However, increasingly it has been shown that even some of these changes are more a result of a sedentary lifestyle than an age-related phenomenon. Most elderly people tend to become less physically active. It is difficult to separate changes intrinsic to the aging process from those arising as a result of a sedentary lifestyle.
Detailed description
Previous large studies have concluded that resting LV diastolic and systolic function decline with age. The cardiovascular system undergoes several age-related changes. For most healthy older individuals, the heart generally functions well under resting conditions. Structural and physiological changes tend to result in diminished exercise tolerance. However, increasingly it has been shown that even some of these changes are more a result of a sedentary lifestyle than an age-related phenomenon. Most elderly people tend to become less physically active. It is difficult to separate changes intrinsic to the aging process from those arising as a result of a sedentary lifestyle. Studies of aging and physical activity usually compare older athletes with sedentary ones, in which physical activity was not found to attenuate the impact on the aging heart. Thus, the investigators set of to find the difference between hearts of elderly who are physically fit as measured with METS to those who are not. And try and understand the basis of this difference.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60's decade | – | Other: Echo stress test60's decade Echo stress test |
| 70's decade | – | Other: Echo stress test70's decade Echo stress test |
| 80's decade | – | Other: Echo stress test80's decade Echo stress test |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients above 65 with preserved systolic function and stress echo on a treadmill between 1 Jan 2012 until 31 Dec 2015 in our facility
Key inclusion criteria (1 listed)
- All patients above 65 with preserved systolic function and stress echo on a treadmill between 1 Jan 2012 until 31 Dec 2015 in the facility.
Key exclusion criteria (1 listed)
- Missing complete information used for data collection.
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 |
|---|---|---|
| Echo stress testEcho stress test | Other | 60's decade, 70's decade, 80's decade |
Primary outcome
Cardiac output at maximal stress test
Time frame: 45 minutes
mean cardiac output in liter per minute for each age group
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 15 Feb 2018.
- 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.
Ehud Chorin, MD principal investigator
972-3-6947520
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Exercise Tolerance, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
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?
Cardiac output at maximal stress test (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2018.