NCT01667913

Brief Summary

The purpose of this study is to examine the relative (ICC) and absolute intertester reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient facility. The data collection is conducted by two physiotherapists, who are blinded to each other. The physiotherapists are randomized so they each are doing an equal number of baseline tests.

Trial Health

57
Monitor

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 Sep 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

August 15, 2012

Last Update Submit

November 13, 2013

Conditions

Hip Fracture

Keywords

Hip Fracture6-minutes walking testReliability

Outcome Measures

Primary Outcomes (1)

  • The 6-Minutes Walking Test

    The 6-Minutes Walking Test performed according to International Guidelines, will be performed on hip fracture patients 3 to 5 weeks after surgery. The testing will be conducted on the same person by two physiotherapists with a one day pause in between test sessions.

    3 to 5 weeks post surgery

Study Arms (1)

6 minutes walking test

NO INTERVENTION
Other: 6 minutes walking test

Interventions

6 minutes walking testOTHER
6 minutes walking test

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or above
  • Hip fracture patients with a Intra - or Extra Capsular hip fracture
  • Testing within 3 - 5 weeks postsurgery in an outpatient facility
  • No weightbearing restrictions on the fractured limb
  • Normal cognitive level (Mini Mental State Examination(MMSE) - score ≥20 points)
  • Participants should not experiencing hip related pain more or less than moderate according to Verbal Ranking Scale when resting
  • To have the ability to write and understand danish language

You may not qualify if:

  • \- MMSE score ≤19 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Center Maribo

Maribo, 4930, Denmark

Location

Related Links

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Jan A Overgaard, Bachelor

    Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark

    PRINCIPAL INVESTIGATOR

  • Morten T Kristensen, Ph.d

    Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor in Physiotherapy

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

DK(1)