Back to resultsReliability of 6-Minutes Walking Test in Hip Fracture Patients
Primary Purpose
Hip Fracture
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
6 minutes walking test
Sponsored by
About this trial
This is an interventional screening trial for Hip Fracture focused on measuring Hip Fracture, 6-minutes walking test, Reliability
Eligibility Criteria
Inclusion Criteria:
- 60 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
Exclusion Criteria:
- MMSE score ≤19 points
Sites / Locations
- Health Center Maribo
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
6 minutes walking test
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01667913
First Posted
August 15, 2012
Last Updated
November 13, 2013
Sponsor
Lolland Community, Denmark
Collaborators
Copenhagen University Hospital, Hvidovre, University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01667913
Brief Title
Reliability of 6-Minutes Walking Test in Hip Fracture Patients
Official Title
The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to low inclusion rate we terminated this study with n=20 participants instead of n=50.
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lolland Community, Denmark
Collaborators
Copenhagen University Hospital, Hvidovre, University of Southern Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Hip Fracture, 6-minutes walking test, Reliability
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 minutes walking test
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
6 minutes walking test
Primary Outcome Measure Information:
Title
The 6-Minutes Walking Test
Description
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.
Time Frame
3 to 5 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
60 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
Exclusion Criteria:
- MMSE score ≤19 points
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Overgaard, Bachelor
Organizational Affiliation
Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten T Kristensen, Ph.d
Organizational Affiliation
Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Health Center Maribo
City
Maribo
ZIP/Postal Code
4930
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.thoracic.org/statements/resources/pfet/sixminute.pdf
Description
Protocol for the 6-Minutes Walking Test
Learn more about this trial
Reliability of 6-Minutes Walking Test in Hip Fracture Patients
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