- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667913
Reliability of 6-Minutes Walking Test in Hip Fracture Patients
November 13, 2013 updated by: Mr. Jan Overgaard, Lolland Community, Denmark
The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maribo, Denmark, 4930
- Health Center Maribo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 6 minutes walking test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 6-Minutes Walking Test
Time Frame: 3 to 5 weeks post surgery
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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.
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3 to 5 weeks post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan A Overgaard, Bachelor, Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark
- Study Director: Morten T Kristensen, Ph.d, Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (ESTIMATE)
August 17, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
November 14, 2013
Last Update Submitted That Met QC Criteria
November 13, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hip Fracture study 7/7-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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