NCT03627273

Brief Summary

Elderly subjects repeated 6MWT with or without walker

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

July 15, 2018

Last Update Submit

February 21, 2019

Conditions

HealthyElderly

Outcome Measures

Primary Outcomes (1)

  • six minutes walking test

    distance

    six minutes

Secondary Outcomes (3)

  • Modified Borg scale

    six minutes

  • heart rate

    six minutes

  • pulsed oxygen saturation

    six minutes

Study Arms (2)

walker

EXPERIMENTAL

'6 minutes walking test' with a walker

Diagnostic Test: 6 minutes walking test with walker

no walker

ACTIVE COMPARATOR

'6 minutes walking test' without walker

Diagnostic Test: 6 minutes walking test

Interventions

6 minutes walking test with walkerDIAGNOSTIC_TEST

to walk during 6 minutes with walker

walker
6 minutes walking testDIAGNOSTIC_TEST

to walk during 6 minutes with walker

no walker

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • clinically stable
  • aged over 65 years
  • could walk
  • did not use walker frames in routine

You may not qualify if:

  • criteria outlined in the European respiratory society/American thoracic society technical standard related to 6MWT
  • impaired cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2018

First Posted

August 13, 2018

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

January 1, 2017

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)