NCT02113748

Brief Summary

This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD. Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.

Trial Health

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Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

April 8, 2014

Last Update Submit

April 11, 2014

Conditions

Keywords

Pulmonary disease, chronic obstructiveDownhill walkingexercise

Outcome Measures

Primary Outcomes (1)

  • changes in 6-minute walking distance

    changes from baseline to Week 12

Study Arms (2)

Downhill walking training

EXPERIMENTAL

Exercise training including treadmill walking with a negative inclination.

Other: Downhill walking training

Conventional walking training

ACTIVE COMPARATOR

Exercise training including treadmill walking without inclination. Possible to progress training intensity with positive inclinations.

Other: Conventional walking training

Interventions

Walk on a treadmill with a negative inclination.

Downhill walking training

Walk on a treadmill without inclination. Possible to progress training intensity with positive inclinations

Conventional walking training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a primary diagnosis of COPD according to internationally accepted guidelines
  • Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium)

You may not qualify if:

  • Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities
  • Absence of exacerbations in the previous month before entering the present study
  • Patients included on the waiting list for lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vl-Brabant, 3000, Belgium

RECRUITING

Related Publications (1)

  • Camillo CA, Osadnik CR, Burtin C, Everaerts S, Hornikx M, Demeyer H, Loeckx M, Rodrigues FM, Maes K, Gayan-Ramirez G, Janssens W, Troosters T. Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. Eur Respir J. 2020 Sep 17;56(3):2000639. doi: 10.1183/13993003.00639-2020. Print 2020 Sep.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thierry Troosters, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Troosters, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations