NCT02209207

Brief Summary

This study will investigate the effects of interval walking training versus continuous walking training in patients with chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized to one of the two intervention groups. All walking training sessions will be performed on the same treadmill. Walking intensity in the continuous walking group will be 60 percent of the average speed of the 6-minute walking test. Patients in the interval training group will perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds alternating with 60 seconds of rest. The total exercise duration will be progressively increased from 10 to 32 minutes.

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

Timeline
Completed

Started Jul 2014

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

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

July 31, 2014

Last Update Submit

February 23, 2016

Conditions

Keywords

chronic obstructive pulmonary diseaseendurance traininginterval trainingcontinuous trainingwalking training

Outcome Measures

Primary Outcomes (1)

  • perceived exertion for dyspnea during walking training

    measured via modified Borg scale (0 to 10)

    day 1 to 21

Secondary Outcomes (10)

  • heart rate during walking training

    day 1 to 21

  • perceived exertion for leg fatigue (Borg-scale)

    during three weeks of rehabilitation

  • Oxygen saturation during walking training

    day 1 to 21

  • fat free mass in kilogram

    day 1 to 21

  • forced expiratory volume in 1 second (FEV1) in liter

    day 1 to 21

  • +5 more secondary outcomes

Study Arms (2)

Continuous walking training

ACTIVE COMPARATOR

n=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed

Device: TreadmillOther: walking training

Interval walking training

ACTIVE COMPARATOR

n=10 patients with COPD Walking intensity 120 percent of 6-minute walking test speed for 1 minute alternating with 1 minute of rest

Device: TreadmillOther: walking training

Interventions

TreadmillDEVICE
Continuous walking trainingInterval walking training
Continuous walking trainingInterval walking training

Eligibility Criteria

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

You may qualify if:

  • COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease \[GOLD\]
  • stationary patient in the Schön Klinik Berchtesgadener Land

You may not qualify if:

  • acute, severe exacerbation of COPD
  • failure to comply with study process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physican (department of pneumology)

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 5, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations