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Eva-Hip, Evaluation of Rehabilitation After Hip-fracture (Eva-Hip)

Primary Purpose

Hip Fracture

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

physiotherapy

conventional treatment

Arm Description

exercises

care as usual

Outcomes

Primary Outcome Measures

change in gait speed

Secondary Outcome Measures

change in activity level

Full Information

First Posted
June 15, 2011
Last Updated
November 19, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
Trondheim Kommune, Norsk kvinners sanitetsforening
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1. Study Identification

Unique Protocol Identification Number
NCT01379456
Brief Title
Eva-Hip, Evaluation of Rehabilitation After Hip-fracture
Acronym
Eva-Hip
Official Title
The Effect on Gait and Activity Level of a Physiotherapy Intervention Aimed at Improving Mediolateral Stability 4 Months After a Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Trondheim Kommune, Norsk kvinners sanitetsforening

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physiotherapy
Arm Type
Experimental
Arm Description
exercises
Arm Title
conventional treatment
Arm Type
No Intervention
Arm Description
care as usual
Intervention Type
Procedure
Intervention Name(s)
physiotherapy
Intervention Description
exercises, 20 sessions over 10 weeks
Primary Outcome Measure Information:
Title
change in gait speed
Time Frame
4,6 and 12 months postfracture
Secondary Outcome Measure Information:
Title
change in activity level
Time Frame
4,6 and 12 month postfracture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Sletvold, MD,PHD
Organizational Affiliation
Department of Neuroscience, Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24996117
Citation
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.
Results Reference
background
PubMed Identifier
28929932
Citation
Hektoen LF, Saltvedt I, Sletvold O, Helbostad JL, Luras H, Halsteinli V. One-year health and care costs after hip fracture for home-dwelling elderly patients in Norway: Results from the Trondheim Hip Fracture Trial. Scand J Public Health. 2016 Dec;44(8):791-798. doi: 10.1177/1403494816674162. Epub 2016 Oct 23.
Results Reference
background
PubMed Identifier
31738792
Citation
Taraldsen K, Thingstad P, Dohl O, Follestad T, Helbostad JL, Lamb SE, Saltvedt I, Sletvold O, Halsteinli V. Short and long-term clinical effectiveness and cost-effectiveness of a late-phase community-based balance and gait exercise program following hip fracture. The EVA-Hip Randomised Controlled Trial. PLoS One. 2019 Nov 18;14(11):e0224971. doi: 10.1371/journal.pone.0224971. eCollection 2019.
Results Reference
result

Learn more about this trial

Eva-Hip, Evaluation of Rehabilitation After Hip-fracture

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