AgeingNCT01765816
Generation 100: Blood Volume and Cardiac Function in Healthy Aging
A study testing high intensity interval training and moderate intensity training 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. As part of the "Generation 100" study, this sub-study project will investigate the effect of exercise on blood volume, cardiopulmonary health and heart function in healthy… Read more about this study
- Who is it for?
- Ages 70 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- high intensity interval training and moderate intensity training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Nov 2014
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ability to walk at least 1km,
- born in 1938,1939,1940,1941 or 1942
- Sufficiently good health to be able to take part in the study, as determined by the researchers
Who cannot join
- Illness or disability that precludes exercise or hinders completion of the study
- Uncontrolled hypertension
- Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
- Active cancer
- Test results indicating that study participation is unsafe
- Inclusion in other studies conflicting with participation in this one
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.
As part of the "Generation 100" study, this sub-study project will investigate the effect of exercise on blood volume, cardiopulmonary health and heart function in healthy aging. Objective is to determine the acute effect of one endurance training session on blood volume in healthy elderly. The working hypothesis is that one interval training session increases total blood volume by 10% in healthy elderly, and that there will be no change after moderate continuous training.
- Conditions
- Ageing
- Being tested
- high intensity interval training, moderate intensity training
- Keywords
- Exercise, Elderly, Blood volume, Hemoglobin
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity interval trainingBehavioural
moderate intensity trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| high intensity interval training | Experimental | one interval training session with 1 x 4 and 4 x 4 minutes interval training at 90-95% of peak heart rate Receives: Behavioral: high intensity interval training; Behavioral: moderate intensity training |
| moderate intensity training | Active comparator | 45 minutes of moderate continuous training at 75% of maximal heart rate Receives: Behavioral: high intensity interval training; Behavioral: moderate intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
total blood volume
carbon monoxide-rebreathing spirometry (Bayreuth, Germany)
Measured: 24 hours
Secondary outcomes (1)
hemoglobin volume
carbon monoxide-rebreathing spirometry (Bayreuth, Germany)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01765816
- Sponsor's protocol ID
- Gen-100-sub1
- Status last verified
- Sep 2020
- First submitted
- 8 Jan 2013
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. 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
- NCT01765816
- Acronym / sponsor ID
- Gen-100-sub1
- Conditions
- Ageing
- Keywords
- Exercise, Elderly, Blood volume, Hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Jan 2013 (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.
As part of the "Generation 100" study, this sub-study project will investigate the effect of exercise on blood volume, cardiopulmonary health and heart function in healthy aging. Objective is to determine the acute effect of one endurance training session on blood volume in healthy elderly. The working hypothesis is that one interval training session increases total blood volume by 10% in healthy elderly, and that there will be no change after moderate continuous training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high intensity interval training | Experimental | Behavioral: high intensity interval training, Behavioral: moderate intensity trainingone interval training session with 1 x 4 and 4 x 4 minutes interval training at 90-95% of peak heart rate |
| moderate intensity training | Active comparator | Behavioral: high intensity interval training, Behavioral: moderate intensity training45 minutes of moderate continuous training at 75% of maximal heart rate |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ability to walk at least 1km,
- born in 1938,1939,1940,1941 or 1942
- Sufficiently good health to be able to take part in the study, as determined by the researchers
Key exclusion criteria (6 listed)
- Illness or disability that precludes exercise or hinders completion of the study
- Uncontrolled hypertension
- Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
- Active cancer
- Test results indicating that study participation is unsafe
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 |
|---|---|---|
| high intensity interval training | Behavioural | high intensity interval training, moderate intensity training |
| moderate intensity training | Behavioural | high intensity interval training, moderate intensity training |
Primary outcome
total blood volume
Time frame: 24 hours
carbon monoxide-rebreathing spirometry (Bayreuth, Germany)
1 secondary outcome
hemoglobin volume
Time frame: 24 hours
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 28 Sep 2020.
- Generation 100 web pageLink 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 high intensity interval training and moderate intensity training 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 3 inclusion and 6 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 28 Sep 2020. 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?
total blood volume (time frame: 24 hours). 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 28 Sep 2020.