- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02209207
Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study
February 23, 2016 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land
Continuous Versus Interval Walking Training in Patients With Severe Chronic Obstructive Pulmonary Disease - a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Schönau am Königssee, Germany, 83471
- Schön Klinik Berchtesgadener Land
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD]
- stationary patient in the Schön Klinik Berchtesgadener Land
Exclusion Criteria:
- acute, severe exacerbation of COPD
- failure to comply with study process
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Continuous walking training
n=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed
|
|
ACTIVE_COMPARATOR: Interval walking training
n=10 patients with COPD Walking intensity 120 percent of 6-minute walking test speed for 1 minute alternating with 1 minute of rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perceived exertion for dyspnea during walking training
Time Frame: day 1 to 21
|
measured via modified Borg scale (0 to 10)
|
day 1 to 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate during walking training
Time Frame: day 1 to 21
|
day 1 to 21
|
|
perceived exertion for leg fatigue (Borg-scale)
Time Frame: during three weeks of rehabilitation
|
during three weeks of rehabilitation
|
|
Oxygen saturation during walking training
Time Frame: day 1 to 21
|
measured via pulse oximeter
|
day 1 to 21
|
fat free mass in kilogram
Time Frame: day 1 to 21
|
measured via Bioimpedance Analysis
|
day 1 to 21
|
forced expiratory volume in 1 second (FEV1) in liter
Time Frame: day 1 to 21
|
measured by spirometry
|
day 1 to 21
|
Sit-to-stand-test
Time Frame: day 1 to 21
|
5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible
|
day 1 to 21
|
6-minute walking test
Time Frame: day 1 to 21
|
the best 6-minute walking test out of two tests on admission and at discharge will be taken
|
day 1 to 21
|
36 item short-form health Survey (SF-36)
Time Frame: day 1 to 21
|
questionnaire for disease unspecific quality of life
|
day 1 to 21
|
chronic respiratory questionnaire (CRQ)
Time Frame: day 1 to 21
|
disease specific quality of life questionnaire
|
day 1 to 21
|
hospital anxiety and depression scale (HADS)
Time Frame: day 1 to 21
|
questionnaire on symptoms of anxiety and depression
|
day 1 to 21
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
July 31, 2014
First Submitted That Met QC Criteria
August 1, 2014
First Posted (ESTIMATE)
August 5, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Walking trial 2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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