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Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study

Primary Purpose

Chronic Obstructive Airway Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Treadmill
walking training
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Airway Disease focused on measuring chronic obstructive pulmonary disease, endurance training, interval training, continuous training, walking training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous walking training

Interval walking training

Arm Description

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

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

Outcomes

Primary Outcome Measures

perceived exertion for dyspnea during walking training
measured via modified Borg scale (0 to 10)

Secondary Outcome Measures

heart rate during walking training
perceived exertion for leg fatigue (Borg-scale)
Oxygen saturation during walking training
measured via pulse oximeter
fat free mass in kilogram
measured via Bioimpedance Analysis
forced expiratory volume in 1 second (FEV1) in liter
measured by spirometry
Sit-to-stand-test
5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible
6-minute walking test
the best 6-minute walking test out of two tests on admission and at discharge will be taken
36 item short-form health Survey (SF-36)
questionnaire for disease unspecific quality of life
chronic respiratory questionnaire (CRQ)
disease specific quality of life questionnaire
hospital anxiety and depression scale (HADS)
questionnaire on symptoms of anxiety and depression

Full Information

First Posted
July 31, 2014
Last Updated
February 23, 2016
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT02209207
Brief Title
Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study
Official Title
Continuous Versus Interval Walking Training in Patients With Severe Chronic Obstructive Pulmonary Disease - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Airway Disease
Keywords
chronic obstructive pulmonary disease, endurance training, interval training, continuous training, walking training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous walking training
Arm Type
Active Comparator
Arm Description
n=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed
Arm Title
Interval walking training
Arm Type
Active Comparator
Arm Description
n=10 patients with COPD Walking intensity 120 percent of 6-minute walking test speed for 1 minute alternating with 1 minute of rest
Intervention Type
Device
Intervention Name(s)
Treadmill
Intervention Type
Other
Intervention Name(s)
walking training
Primary Outcome Measure Information:
Title
perceived exertion for dyspnea during walking training
Description
measured via modified Borg scale (0 to 10)
Time Frame
day 1 to 21
Secondary Outcome Measure Information:
Title
heart rate during walking training
Time Frame
day 1 to 21
Title
perceived exertion for leg fatigue (Borg-scale)
Time Frame
during three weeks of rehabilitation
Title
Oxygen saturation during walking training
Description
measured via pulse oximeter
Time Frame
day 1 to 21
Title
fat free mass in kilogram
Description
measured via Bioimpedance Analysis
Time Frame
day 1 to 21
Title
forced expiratory volume in 1 second (FEV1) in liter
Description
measured by spirometry
Time Frame
day 1 to 21
Title
Sit-to-stand-test
Description
5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible
Time Frame
day 1 to 21
Title
6-minute walking test
Description
the best 6-minute walking test out of two tests on admission and at discharge will be taken
Time Frame
day 1 to 21
Title
36 item short-form health Survey (SF-36)
Description
questionnaire for disease unspecific quality of life
Time Frame
day 1 to 21
Title
chronic respiratory questionnaire (CRQ)
Description
disease specific quality of life questionnaire
Time Frame
day 1 to 21
Title
hospital anxiety and depression scale (HADS)
Description
questionnaire on symptoms of anxiety and depression
Time Frame
day 1 to 21

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

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Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study

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