Eva-Hip, Evaluation of Rehabilitation After Hip-fracture | NCT01379456

Studies
Eva-Hip, Evaluation of Rehabilitation After Hip-fracture

NCT01379456

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Nov 21, 2019Actual

Enrollment

223Actual

Phase

Not Applicable

Conditions

Hip Fracture

Interventions

physiotherapy

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

Nov 2019

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

Feb 2011Actual

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jun 15, 2011

First Submission Date that Met QC Criteria

Jun 21, 2011

First Posted Date

Jun 23, 2011Estimated

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

Nov 19, 2019

Last Update Posted Date

Nov 21, 2019Actual

Name	Class
Trondheim Kommune	OTHER
Norsk kvinners sanitetsforening	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity.

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

223Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
physiotherapy	Experimental	exercises	Procedure: physiotherapy
conventional treatment	No Intervention	care as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physiotherapy	Procedure	exercises, 20 sessions over 10 weeks	physiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in gait speed		4,6 and 12 months postfracture

Secondary Outcomes

Measure	Description	Time Frame
change in activity level		4,6 and 12 month postfracture

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Home dwelling prior to fracture
age>70yr
able to walk 10m

Exclusion Criteria:

expected life expectancies <3 months
exercises contraindicated due to medical conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olav Sletvold, MD,PHD	Department of Neuroscience, Norwegian University of Science and Technology	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24996117	Background	Thingstad P, Taraldsen K, Hagen G, Sand S, Saltvedt I, Sletvold O, Helbostad JL. Effectiveness of task specific gait and balance exercise 4 months after hip fracture: protocol of a randomized controlled trial--the Eva-hip study. Physiother Res Int. 2015 Jun;20(2):87-99. doi: 10.1002/pri.1599. Epub 2014 Jul 3.
28929932	Background

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

ID	Term
D013812	Therapeutics
D012046	Rehabilitation