NCT01765816

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

January 8, 2013

Last Update Submit

September 25, 2020

Conditions

Keywords

ExerciseElderlyBlood volumeHemoglobin

Outcome Measures

Primary Outcomes (1)

  • total blood volume

    carbon monoxide-rebreathing spirometry (Bayreuth, Germany)

    24 hours

Secondary Outcomes (1)

  • hemoglobin volume

    24 hours

Study Arms (2)

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

Behavioral: high intensity interval trainingBehavioral: moderate intensity training

moderate intensity training

ACTIVE COMPARATOR

45 minutes of moderate continuous training at 75% of maximal heart rate

Behavioral: high intensity interval trainingBehavioral: moderate intensity training

Interventions

high intensity interval trainingmoderate intensity training
high intensity interval trainingmoderate intensity training

Eligibility Criteria

Age70 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7006, Norway

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ulrik Wisløff, Professor

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

August 1, 2012

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

September 28, 2020

Record last verified: 2020-09

Locations