Text Size

Generation 100: Blood Volume and Cardiac Function in Healthy Aging

This study is currently recruiting participants.
Verified January 2013 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01765816
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 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.


Condition Intervention
Ageing
 Behavioral: high intensity interval training
Behavioral: moderate intensity training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • total blood volume [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    carbon monoxide-rebreathing spirometry (Bayreuth, Germany)


Secondary Outcome Measures:
  • hemoglobin volume [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    carbon monoxide-rebreathing spirometry (Bayreuth, Germany)


Estimated Enrollment: 25
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Behavioral: high intensity interval training Behavioral: moderate intensity training
Active Comparator: moderate intensity training
45 minutes of moderate continuous training at 75% of maximal heart rate
 Behavioral: high intensity interval training Behavioral: moderate intensity training

  Eligibility

Ages Eligible for Study:   70 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765816

Contacts
Contact: Trine Karlsen, PhD 0047 72828058 trine.karlsen@ntnu.no

Locations
Norway
Norwegian University of Science and Technology Recruiting
Trondheim, Norway, 7006
Contact: Trine Karlsen, PhD     0047 72828058     trine.karlsen@ntnu.no    
Contact: Ulrik Wisløff, PhD prof     0047 7288113     ulrik.wisloff@ntnu.no    
Principal Investigator: Trine Karlsen, PhD            
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Ulrik Wisløff, Professor Norwegian University of Science and Technology
  More Information

Additional Information:
Generation 100 web page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01765816     History of Changes
Other Study ID Numbers: Gen-100-sub1
Study First Received: January 8, 2013
Last Updated: January 8, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
Exercise
Elderly
Blood volume
Hemoglobin

ClinicalTrials.gov processed this record on May 23, 2013