- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627273
6MWT With and Without Walker
February 21, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Comparison of 6 Minute Walk Test With and Without Walker
Elderly subjects repeated 6MWT with or without walker
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
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
-
-
-
Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinically stable
- aged over 65 years
- could walk
- did not use walker frames in routine
Exclusion Criteria:
- criteria outlined in the European respiratory society/American thoracic society technical standard related to 6MWT
- impaired cognitive function
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: walker
'6 minutes walking test' with a walker
|
to walk during 6 minutes with walker
|
Active Comparator: no walker
'6 minutes walking test' without walker
|
to walk during 6 minutes with walker
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
six minutes walking test
Time Frame: six minutes
|
distance
|
six minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Borg scale
Time Frame: six minutes
|
dyspnea
|
six minutes
|
heart rate
Time Frame: six minutes
|
heart beat rate
|
six minutes
|
pulsed oxygen saturation
Time Frame: six minutes
|
saturation pulsed oxygen
|
six minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
July 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
July 15, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 13, 2018
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 6MWTrollator
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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