Chronic Obstructive Airway DiseaseNCT02209207
Continuous Versus Interval Walking Training in Patients With COPD - a Pilot Study
A study testing Treadmill and walking training in people with Chronic Obstructive Airway Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- Treadmill and walking training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Nov 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD]
- stationary patient in the Schön Klinik Berchtesgadener Land
Who cannot join
- acute, severe exacerbation of COPD
- failure to comply with study process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Airway Disease
- Being tested
- Treadmill, walking training
- Keywords
- chronic obstructive pulmonary disease, endurance training, interval training, continuous training, walking training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillDevice
walking trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Continuous walking training | Active comparator | n=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed Receives: Device: Treadmill; Other: 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 Receives: Device: Treadmill; Other: walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
perceived exertion for dyspnea during walking training
measured via modified Borg scale (0 to 10)
Measured: day 1 to 21
Secondary outcomes (10)
heart rate during walking training
Measured: day 1 to 21
perceived exertion for leg fatigue (Borg-scale)
Measured: during three weeks of rehabilitation
Oxygen saturation during walking training
measured via pulse oximeter
Measured: day 1 to 21
fat free mass in kilogram
measured via Bioimpedance Analysis
Measured: day 1 to 21
forced expiratory volume in 1 second (FEV1) in liter
measured by spirometry
Measured: day 1 to 21
Sit-to-stand-test
5 repetitions of standing up and sitting down from a chair with crossed arms as quick as possible
Measured: day 1 to 21
6-minute walking test
the best 6-minute walking test out of two tests on admission and at discharge will be taken
Measured: day 1 to 21
36 item short-form health Survey (SF-36)
questionnaire for disease unspecific quality of life
Measured: day 1 to 21
chronic respiratory questionnaire (CRQ)
disease specific quality of life questionnaire
Measured: day 1 to 21
hospital anxiety and depression scale (HADS)
questionnaire on symptoms of anxiety and depression
Measured: day 1 to 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway 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
- 20 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
- NCT02209207
- Sponsor's protocol ID
- Walking trial 2014
- Status last verified
- Feb 2016
- First submitted
- 31 Jul 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Interval Walking Training in Patients With Severe Chronic Obstructive Pulmonary Disease - a Pilot Study
- ClinicalTrials.gov ID
- NCT02209207
- Acronym / sponsor ID
- Walking trial 2014
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- chronic obstructive pulmonary disease, endurance training, interval training, continuous training, walking training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous walking training | Active comparator | Device: Treadmill, Other: walking trainingn=10 patients with COPD Walking intensity 60 percent of 6-minute walking test speed |
| Interval walking training | Active comparator | Device: Treadmill, Other: walking trainingn=10 patients with COPD Walking intensity 120 percent of 6-minute walking test speed for 1 minute alternating with 1 minute of rest |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- COPD stage III or IV according to the Global Initiative for chronic obstructive lung disease [GOLD]
- stationary patient in the Schön Klinik Berchtesgadener Land
Key exclusion criteria (2 listed)
- acute, severe exacerbation of COPD
- failure to comply with study process
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 | Device | Continuous walking training, Interval walking training |
| walking training | Other | Continuous walking training, Interval walking training |
Primary outcome
perceived exertion for dyspnea during walking training
Time frame: day 1 to 21
measured via modified Borg scale (0 to 10)
10 secondary outcomes
heart rate during walking training
Time frame: day 1 to 21
perceived exertion for leg fatigue (Borg-scale)
Time frame: during three weeks of rehabilitation
Oxygen saturation during walking training
Time frame: day 1 to 21
fat free mass in kilogram
Time frame: day 1 to 21
forced expiratory volume in 1 second (FEV1) in liter
Time frame: day 1 to 21
Sit-to-stand-test
Time frame: day 1 to 21
6-minute walking test
Time frame: day 1 to 21
36 item short-form health Survey (SF-36)
Time frame: day 1 to 21
chronic respiratory questionnaire (CRQ)
Time frame: day 1 to 21
hospital anxiety and depression scale (HADS)
Time frame: day 1 to 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 24 Feb 2016.
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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 and walking training in people with Chronic Obstructive Airway 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 2 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 24 Feb 2016. 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?
perceived exertion for dyspnea during walking training (time frame: day 1 to 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 24 Feb 2016.