Generation 100: Blood Volume and Cardiac Function in Heal... | NCT01765816

Studies
Generation 100: Blood Volume and Cardiac Function in Healthy Aging

NCT01765816

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Sep 28, 2020Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Ageing

Interventions

high intensity interval training
moderate intensity training

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2020

Last Update Posted Date

Sep 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 training Behavioral: moderate intensity training
moderate intensity training	Active Comparator	45 minutes of moderate continuous training at 75% of maximal heart rate	Behavioral: high intensity interval training Behavioral: moderate intensity training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high intensity interval training	Behavioral		high intensity interval training moderate intensity training
moderate intensity training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total blood volume	carbon monoxide-rebreathing spirometry (Bayreuth, Germany)	24 hours

Secondary Outcomes

Measure	Description	Time Frame
hemoglobin volume	carbon monoxide-rebreathing spirometry (Bayreuth, Germany)	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

75 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrik Wisløff, Professor	Norwegian University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian University of Science and Technology		Trondheim		7006	Norway

Label	URL
Generation 100 web page	View source

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D000072696	High-Intensity Interval Training

Ancestor Terms

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement

Browse Leaves

Not provided

Browse Branches

Not provided