Diastolic DysfunctionNCT00804518
Effect of Exercise on Heart Function in Healthy Elderly People
A study testing Aerobic interval training in people with Diastolic Dysfunction, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine the effect of aerobic interval training on left- and right ventricular diastolic- and systolic function on healthy, sedate people over 70 years. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Aerobic interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2008to Aug 2009
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- over 70 years, healthy
- not exercising more than twice per week
Who cannot join
- chronic illness
- chronic use of any medication
- regular smoking
- metabolic or cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Interval Training Reduces and Compensates Age Related Decline in Cardiac Function
The purpose of this study is to determine the effect of aerobic interval training on left- and right ventricular diastolic- and systolic function on healthy, sedate people over 70 years. The old sedate cohort will be compared to young, sedate subjects also performing aerobic interval training and old master athletes without intervention.
Read the detailed description
Aging is associated with a reduced diastolic and systolic function of the heart. Earlier studies have shown that physical exercise can improve both systolic and diastolic function. However the impact on age-related cardiac function is to some extent conflicting. The use of different training intensities will impact on the cardiac result. We have in earlier studies shown aerobic interval training at 90 % of maximal heart rate (4x4 minutes) to have more impact on cardiac function, endothelial function and maximal oxygen uptake compared to moderate intensity.
To our knowledge the effect of aerobic interval training on cardiac function has not been studied in an old, sedate group before.
- Conditions
- Diastolic Dysfunction
- Being tested
- Aerobic interval training
- Keywords
- Aging, Diastolic dysfunction, Systolic function, Exercise, Echocardiography, tissue Doppler imaging, Cardiac function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingOther
High intensity aerobic interval training consists of 10 minutes warm up at ~60% of maximal heart rate, 4x4 minutes intervals at 90-95 % of maximal heart rate corresponding to 85-90% of VO2max) walking/running uphill on a treadmill, with three minutes active pause between the exercise bouts at 60-70% maximal heart rate. The session is terminated with 3 minutes cool down. Total exercise time is 38 minutes.The training is supervised by an exercise physiologist and the subjects train 3 times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Not described Receives: Other: Aerobic interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of left and right ventricular early diastolic tissue velocity at rest and sub maximal exercise ,e'.
Measured: 12 weeks
Secondary outcomes (1)
Improvement of left and right ventricular systolic tissue velocity function at rest and sub maximal exercise, S'.
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Bjork Ingul, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804518
- Sponsor's protocol ID
- 4.2008.2177
- Status last verified
- Jul 2016
- First submitted
- 8 Dec 2008
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Molmen HE, Wisloff U, Aamot IL, Stoylen A, Ingul CB. Aerobic interval training compensates age related decline in cardiac function. Scand Cardiovasc J. 2012 Jun;46(3):163-71. doi: 10.3109/14017431.2012.660192. Epub 2012 Feb 20.
PubMed 22273242
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Interval Training Reduces and Compensates Age Related Decline in Cardiac Function
- ClinicalTrials.gov ID
- NCT00804518
- Acronym / sponsor ID
- 4.2008.2177
- Conditions
- Diastolic Dysfunction
- Keywords
- Aging, Diastolic dysfunction, Systolic function, Exercise, Echocardiography, tissue Doppler imaging, Cardiac function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Dec 2008 (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.
The purpose of this study is to determine the effect of aerobic interval training on left- and right ventricular diastolic- and systolic function on healthy, sedate people over 70 years. The old sedate cohort will be compared to young, sedate subjects also performing aerobic interval training and old master athletes without intervention.
Detailed description
Aging is associated with a reduced diastolic and systolic function of the heart. Earlier studies have shown that physical exercise can improve both systolic and diastolic function. However the impact on age-related cardiac function is to some extent conflicting. The use of different training intensities will impact on the cardiac result. We have in earlier studies shown aerobic interval training at 90 % of maximal heart rate (4x4 minutes) to have more impact on cardiac function, endothelial function and maximal oxygen uptake compared to moderate intensity.
To our knowledge the effect of aerobic interval training on cardiac function has not been studied in an old, sedate group before.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Other: Aerobic interval training |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- over 70 years, healthy
- not exercising more than twice per week
Key exclusion criteria (4 listed)
- chronic illness
- chronic use of any medication
- regular smoking
- metabolic or cardiovascular diseases
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 |
|---|---|---|
| Aerobic interval trainingHigh intensity aerobic interval training consists of 10 minutes warm up at ~60% of maximal heart rate, 4x4 minutes intervals at 90-95 % of maximal heart rate corresponding to 85-90% of VO2max) walking/running uphill on a treadmill, with three minutes active pause between the exercise bouts at 60-70% maximal heart rate. The session is terminated with 3 minutes cool down. Total exercise time is 38 minutes.The training is supervised by an exercise physiologist and the subjects train 3 times per week for 12 weeks. | Other | Exercise intervention |
Primary outcome
Improvement of left and right ventricular early diastolic tissue velocity at rest and sub maximal exercise ,e'.
Time frame: 12 weeks
1 secondary outcome
Improvement of left and right ventricular systolic tissue velocity function at rest and sub maximal exercise, S'.
Time frame: 12weeks
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 18 Jul 2016.
- Results publication: PubMed 22273242Molmen HE, Wisloff U, Aamot IL, Stoylen A, Ingul CB. Aerobic interval training compensates age related decline in cardiac function. Scand Cardiovasc J. 2012 Jun;46(3):163-71. doi: 10.3109/14017431.2012.660192. Epub 2012 Feb 20.
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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.
Charlotte Bjork Ingul, PhD principal investigator
National Taiwan Normal 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 Aerobic interval training in people with Diastolic Dysfunction, 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 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 18 Jul 2016. 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?
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?
Improvement of left and right ventricular early diastolic tissue velocity at rest and sub maximal exercise ,e'. (time frame: 12 weeks). 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 NCT00804518, which also lists 1 linked publication.
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 18 Jul 2016.