Generation 100: Blood Volume and Cardiac Function in Healthy Aging

September 25, 2020 updated by: Norwegian University of Science and Technology

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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trondheim, Norway, 7006
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 71 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ulrik Wisløff, Professor, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

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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