NCT04205448

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

December 18, 2019

Last Update Submit

January 26, 2021

Conditions

Fall

Outcome Measures

Primary Outcomes (1)

  • Fall-related injuries

    identified in electronic patient record in primary care

    First year

Study Arms (2)

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

Physical exercizeBEHAVIORAL

10 weeks group exercize followed by community-based voluntary exercize

Exercize group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bomlo municipality

Bremnes, Bomlo, 5430, Norway

Location

Study Officials

  • Kjetil A Gjoesaeter

    Bomlo Municipality

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Community physician

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 19, 2019

Study Start

March 1, 2019

Primary Completion

March 31, 2020

Study Completion

January 25, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Accepted for publication in Norwegian scientific journal "Utposten".

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Spring 2021
Access Criteria
Open access, available in Norwegian
More information

Locations

NO(1)