6MWT With and Without Walker
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT03627273
Collaborator
(none)
86
1
2
30.1
2.9
Study Details
Study Description
Brief Summary
Elderly subjects repeated 6MWT with or without walker
Study Design
Study Type:
Interventional
Actual Enrollment
:
86 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
Comparison of 6 Minute Walk Test With and Without Walker
Actual Study Start Date
:
Jul 1, 2014
Actual Primary Completion Date
:
Jul 1, 2015
Actual Study Completion Date
:
Jan 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: walker '6 minutes walking test' with a walker |
Diagnostic Test: 6 minutes walking test with walker
to walk during 6 minutes with walker
|
| Active Comparator: no walker '6 minutes walking test' without walker |
Diagnostic Test: 6 minutes walking test
to walk during 6 minutes with walker
|
Outcome Measures
Primary Outcome Measures
- six minutes walking test [six minutes]
distance
Secondary Outcome Measures
- Modified Borg scale [six minutes]
dyspnea
- heart rate [six minutes]
heart beat rate
- pulsed oxygen saturation [six minutes]
saturation pulsed oxygen
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques universitaires Saint-Luc | Brussels | Belgium | 1200 |
Sponsors and Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03627273
Other Study ID Numbers:
- 6MWTrollator
First Posted:
Aug 13, 2018
Last Update Posted:
Feb 25, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No