Chronic Obstructive Pulmonary DiseaseNCT03120169
Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD
A study testing treadmill endurance training and cycling endurance training in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- treadmill endurance training and cycling endurance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 30 Mar 2017to 27 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- treadmill endurance training, cycling endurance training
- Keywords
- COPD, exercise, training, cycling, treadmill, walking, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill endurance trainingOther
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.
cycling endurance trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| treadmill endurance training | Active comparator | Not described Receives: Other: treadmill endurance training |
| cycling endurance training | Active comparator | Not described Receives: Other: cycling endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: measurement on day 1 and 21
Secondary outcomes (10)
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.
Measured: measurement on day 1 and 21
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.
Measured: measurement on day 1 and 21
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.
Measured: measurement on day 1 and 21
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
Measured: measurement on day 1 and 21
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
Measured: measurement on day 1 and 21
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
Measured: measurement on day 1 and 21
Change in peak muscle strength
isometric peak torque of the knee extensor muscles are measured in 90° knee angle
Measured: measurement on day 1 and 21
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.
Measured: measurement on day 1 and 21
Change in 6-minute Walk test
the best out of two 6- Minute Walk Tests will be used for analysis
Measured: measurement on day 1 and 21
Change in Hospital anxiety and Depression scale
the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression
Measured: measurement on day 1 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start30 Mar 2017
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120169
- Sponsor's protocol ID
- treadmill vs. cycling in COPD
- Status last verified
- Feb 2018
- First submitted
- 13 Apr 2017
- Last updated
- 15 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03120169
- Acronym / sponsor ID
- treadmill vs. cycling in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, exercise, training, cycling, treadmill, walking, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treadmill endurance training | Active comparator | Other: treadmill endurance training |
| cycling endurance training | Active comparator | Other: cycling endurance training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treadmill endurance trainingn = 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. | Other | treadmill endurance training |
| cycling endurance trainingn=15 patients with COPD. Cycling intensity will initially be set at 60 percent of Peak work rate with progressive increase in Duration and intensity | Other | cycling endurance training |
Primary outcome
Change in step symmetry during 20m walking
Time frame: measurement on day 1 and 21
Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis
10 secondary outcomes
Change in balance performance during semi-tandem stance
Time frame: measurement on day 1 and 21
Change in balance performance during Romberg stance
Time frame: measurement on day 1 and 21
Change in balance performance during single leg stance
Time frame: measurement on day 1 and 21
Change in muscle power during counter movement jump
Time frame: measurement on day 1 and 21
Change in 1 Minute sit to stand test
Time frame: measurement on day 1 and 21
Change in 5 Repetition sit to stand test
Time frame: measurement on day 1 and 21
Change in peak muscle strength
Time frame: measurement on day 1 and 21
Change in 4 meter gait Speed test
Time frame: measurement on day 1 and 21
Change in 6-minute Walk test
Time frame: measurement on day 1 and 21
Change in Hospital anxiety and Depression scale
Time frame: measurement on day 1 and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill endurance training and cycling endurance training in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in step symmetry during 20m walking (time frame: measurement on day 1 and 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.