NCT02613351

Brief Summary

The aim of this study is to determine if: the large muscles of the leg, activated during walking, are also active during scooting; whether scooting alters the relationship between leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

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

Timeline
Completed

Started Dec 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

November 17, 2015

Last Update Submit

November 16, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Exercise ToleranceLung Diseases, Obstructive

Outcome Measures

Primary Outcomes (1)

  • slope of the relationship between self-reported breathing and leg heaviness using Borg scale

    Borg scale ratings of breathing and leg heaviness will be measured during stepwise incremental speed exercise tests. The relationship between leg and breathing heaviness with increasing demand (speed) is quantified by the slope of the relationship between self-reported breathing and leg heaviness under each condition of customary walking and scooting.

    1 week

Study Arms (1)

scooting

EXPERIMENTAL

incremental test to establish the relationship between leg and breathing heaviness with increasing demand (speed) during scooting

Device: scooting

Interventions

scootingDEVICE

three-wheeled scooter (Monark 662, Monark Exercise AB Sweden) comprised of a single front wheel that provides steering and two rear wheels that create a wide base of support.

scooting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD: FEV1 \< 80 % and FEV1/FVC \< 0.7;
  • Able to communicate in English
  • Clinically stable

You may not qualify if:

  • predominant co-morbidities or treatments that might influence the results of exercise testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westpark Health Care Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Roger S Goldstein, MD

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Directory Respiratory Medicine

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 24, 2015

Study Start

December 1, 2015

Primary Completion

August 14, 2017

Study Completion

August 14, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

CA(1)