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Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
treadmill endurance training
cycling endurance 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 Pulmonary Disease focused on measuring COPD, exercise, training, cycling, treadmill, walking, pulmonary rehabilitation

Eligibility Criteria

50 Years - 80 Years (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
  • impaired exercise capacity (6 Minute walk distance of less than 70% of the reference values from Troosters et al.)

Exclusion Criteria:

  • acute, severe exacerbation of COPD
  • carbon dioxide of more than 45 mmHg at rest
  • any disabilities that prevent patient form walking or cycling
  • Patient is not able to walk 20 meters without any aid (for example rollator)

Sites / Locations

  • Schoen Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

treadmill endurance training

cycling endurance training

Arm Description

Outcomes

Primary Outcome Measures

Change in step symmetry during 20m walking
Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis

Secondary Outcome Measures

Change in balance performance during semi-tandem stance
patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.
Change in balance performance during Romberg stance
patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.
Change in balance performance during single leg stance
patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.
Change in muscle power during counter movement jump
patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight
Change in 1 Minute sit to stand test
Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute
Change in 5 Repetition sit to stand test
Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible
Change in peak muscle strength
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
Change in 4 meter gait Speed test
patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.
Change in 6-minute Walk test
the best out of two 6- Minute Walk Tests will be used for analysis
Change in Hospital anxiety and Depression scale
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression

Full Information

First Posted
April 13, 2017
Last Updated
February 14, 2018
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT03120169
Brief Title
Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD
Official Title
Effects of a Three Week Treadmill Versus Cycling Endurance Training on Balance, Gait Performance and Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Aim of this study is to investigate the effects of treadmill versus cycling endurance training on Balance, gait performance and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. Walking intensity in the treadmill group will be set at 80 percent of the average speed of the 6-minute walking test. The cycling group will exercise at an intensity of 60 percent according to an Initial incremental cycling test. Patients will perform 5 to 6 training sessions per week. The total exercise duration will be progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be progressively increased if perceived exertion during exercise is rated below 3 on the modified 10-point Borg scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, exercise, training, cycling, treadmill, walking, pulmonary rehabilitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
treadmill endurance training
Arm Type
Active Comparator
Arm Title
cycling endurance training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
treadmill endurance training
Intervention Description
n = 15 patients with COPD. Walking intensity will be initially set at 80 percent of 6-minute Walking test Speed with progressive increase in Duration and intensity.
Intervention Type
Other
Intervention Name(s)
cycling endurance training
Intervention Description
n=15 patients with COPD. Cycling intensity will initially be set at 60 percent of Peak work rate with progressive increase in Duration and intensity
Primary Outcome Measure Information:
Title
Change in step symmetry during 20m walking
Description
Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis
Time Frame
measurement on day 1 and 21
Secondary Outcome Measure Information:
Title
Change in balance performance during semi-tandem stance
Description
patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.
Time Frame
measurement on day 1 and 21
Title
Change in balance performance during Romberg stance
Description
patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.
Time Frame
measurement on day 1 and 21
Title
Change in balance performance during single leg stance
Description
patients stand still for 10 seconds on a force platform that measures absolute path length of the center of force.
Time Frame
measurement on day 1 and 21
Title
Change in muscle power during counter movement jump
Description
patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight
Time Frame
measurement on day 1 and 21
Title
Change in 1 Minute sit to stand test
Description
Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute
Time Frame
measurement on day 1 and 21
Title
Change in 5 Repetition sit to stand test
Description
Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible
Time Frame
measurement on day 1 and 21
Title
Change in peak muscle strength
Description
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
Time Frame
measurement on day 1 and 21
Title
Change in 4 meter gait Speed test
Description
patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk.
Time Frame
measurement on day 1 and 21
Title
Change in 6-minute Walk test
Description
the best out of two 6- Minute Walk Tests will be used for analysis
Time Frame
measurement on day 1 and 21
Title
Change in Hospital anxiety and Depression scale
Description
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression
Time Frame
measurement on day 1 and 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD Stage III or IV according to the global initiative for chronic obstructive lung disease impaired exercise capacity (6 Minute walk distance of less than 70% of the reference values from Troosters et al.) Exclusion Criteria: acute, severe exacerbation of COPD carbon dioxide of more than 45 mmHg at rest any disabilities that prevent patient form walking or cycling Patient is not able to walk 20 meters without any aid (for example rollator)
Facility Information:
Facility Name
Schoen Klinik Berchtesgadener Land
City
Schoenau Am Koenigssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

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Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD

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