Fall Prevention Study Among Seniors in Bomlo | NCT04205448

Studies
Fall Prevention Study Among Seniors in Bomlo

NCT04205448

Sponsor

Kjersti Helen Folleso

Status

Completed

Last Update Posted

Jan 28, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Fall

Interventions

Physical exercize

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

Jan 2021

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

Mar 1, 2019Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Jan 25, 2021Actual

First Submitted Date

Dec 18, 2019

First Submission Date that Met QC Criteria

Dec 18, 2019

First Posted Date

Dec 19, 2019Actual

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

Jan 26, 2021

Last Update Posted Date

Jan 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.

Detailed Description

Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercize group	Experimental	10 weeks of physical exercise. Testing of strength and balance.	Behavioral: Physical exercize
Control group	No Intervention	Testing of strength and balance.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical exercize	Behavioral	10 weeks group exercize followed by community-based voluntary exercize	Exercize group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fall-related injuries	identified in electronic patient record in primary care	First year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent.

Exclusion Criteria:

Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 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
Kjetil A Gjoesaeter	Bomlo Municipality	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bomlo municipality		Bremnes	Bomlo	5430	Norway

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Accepted for publication in Norwegian scientific journal "Utposten".

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

Spring 2021

Access Criteria

Open access, available in Norwegian

URL

http://www.utposten.no