Intensity of Physical Activity Measured by Activity Monit... | NCT02017847

Studies
Intensity of Physical Activity Measured by Activity Monitors in Elderly Persons

NCT02017847

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

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

Aug 2016

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

Nov 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Dec 17, 2013

First Posted Date

Dec 23, 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

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

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

Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70.

Detailed Description

Activity monitors measure activity in counts. The higher the counts, the higher the intensity of the measured activity. In this study the count cut off points for low, moderate and high intensity activity will be investigated in a population of elderly people over the age of 70. This information will subsequently (in future studies) be used to investigate the physical activity patterns in a population of elderly over the age of 70 who have worn an activity monitor for a duration of 7 days.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gen100		150 participants in the Generation 100 study with anticipated 3000 participants aged 70-75

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity of physical activity	measured in counts by activity monitors	1 year

Secondary Outcomes

Not provided

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
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

76 Years

Standard Ages

Older Adult

Study Population

Persons in the age of 70-76 living in Trondheim, Norway

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina Zisko, MSc	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NTNU, Faculty of Medicine Department, of Circulation and Medical Imaging		Trondheim		7491	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26238198	Result	Zisko N, Carlsen T, Salvesen O, Aspvik NP, Ingebrigtsen JE, Wisloff U, Stensvold D. New relative intensity ambulatory accelerometer thresholds for elderly men and women: the Generation 100 study. BMC Geriatr. 2015 Aug 4;15:97. doi: 10.1186/s12877-015-0093-1.