NCT01379456

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 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

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

5.3 years

First QC Date

June 15, 2011

Last Update Submit

November 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in gait speed

    4,6 and 12 months postfracture

Secondary Outcomes (1)

  • change in activity level

    4,6 and 12 month postfracture

Study Arms (2)

physiotherapy

EXPERIMENTAL

exercises

Procedure: physiotherapy

conventional treatment

NO INTERVENTION

care as usual

Interventions

physiotherapyPROCEDURE

exercises, 20 sessions over 10 weeks

physiotherapy

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7006, Norway

Location

Related Publications (3)

  • 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.

    PMID: 24996117BACKGROUND
  • 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.

    PMID: 28929932BACKGROUND
  • 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.

MeSH Terms

Conditions

Hip Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Olav Sletvold, MD,PHD

    Department of Neuroscience, Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 23, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations