- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765816
Generation 100: Blood Volume and Cardiac Function in Healthy Aging
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway, 7006
- Norwegian University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: high intensity interval training
one interval training session with 1 x 4 and 4 x 4 minutes interval training at 90-95% of peak heart rate
|
|
|
Active Comparator: moderate intensity training
45 minutes of moderate continuous training at 75% of maximal heart rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total blood volume
Time Frame: 24 hours
|
carbon monoxide-rebreathing spirometry (Bayreuth, Germany)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hemoglobin volume
Time Frame: 24 hours
|
carbon monoxide-rebreathing spirometry (Bayreuth, Germany)
|
24 hours
|
Collaborators and Investigators
Investigators
- Study Chair: Ulrik Wisløff, Professor, Norwegian University of Science and Technology
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Gen-100-sub1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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