NCT02631434

Brief Summary

Comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2013

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

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

November 25, 2015

Last Update Submit

December 11, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • number of sit-to-stand movement

    1 minute

  • walked distance

    6 minutes

Secondary Outcomes (3)

  • heart rate

    6 minutes

  • fraction of oxygen-saturated hemoglobin measured by pulsed oximeter

    6 minutes

  • breathlessness measured by visual analogic scale

    6 minutes

Study Arms (2)

sit-to-stand

EXPERIMENTAL

To perform a sit-to-stand test

Procedure: sit-to-stand test

six minute walking test

ACTIVE COMPARATOR

To perform a six minutes walking test

Procedure: six-minutes walking test

Interventions

sit-to-stand testPROCEDURE
sit-to-stand
six-minutes walking testPROCEDURE
six minute walking test

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically stable for a minimum of 4 weeks
  • no recent infectious exacerbations

You may not qualify if:

  • musculoskeletal or joint disorders
  • contra-indications to perform exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique universitaire Saint-Luc

Brussels, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 16, 2015

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

BE(1)