Chronic Obstructive Pulmonary DiseaseNCT03802357
Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients
A study testing Exercise training in people with Chronic Obstructive Pulmonary Disease and Alpha 1-Antitrypsin Deficiency, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Pulmonary rehabilitation (PR) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Alpha 1-Antitrypsin Deficiency
- What is being tested?
- Exercise training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2019to 31 Dec 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients with A1ATD (genotype PiZZ)
- COPD patients without A1ATD (genotype PiMM)
- Global initiative for chronic obstructive lung disease (GOLD) stage III-IV
- Medical Treatment according to recent A1ATD guidelines
Who cannot join
- General exclusion criteria for physical Training such as acute coronary Syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic comorbidities which prevent patients from participating in exercise Training program.
- No written informed consent
- Non-compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, 83471
Klaus Kenn, Prof. Dr., 0865293 ext. 1540, kkenn@schoen-klinik.de
Inga Jarosch, Dr., 0865293 ext. 1730, ijarosch@schoen-klinik.de
About this study
Official title: Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients
Pulmonary rehabilitation (PR) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a 3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)[1]. These between-group differences were mirrored by missing adaptations of the fatigue-resistant skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial because it enables patients for physical endurance activities (walking, cycling etc.) during their daily life.
The aim of this study is to compare the effects of an exercise Training program with high vs. moderate Training intensity in order to find a Training modality which improves Training effects in A1ATD patients.
- Being tested
- Exercise training
- Keywords
- Pulmonary rehabilitation, Exercise training, Alpha-1 Antitrypsin deficiency
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingProcedure or surgery
Patients perform an exercise Training program of 3 weeks Duration including endurance Training, resistance Training and squat Training. This program is part of an inpatient pulmonary Rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| High training intensity | Experimental | Exercise Training with high intensities consists of a cycling Interval Training at 100% of the individual Peak work rate, resistance Training for 3 sets à 8 repetitions and squats on a Vibration plate. Receives: Procedure: Exercise training |
| moderate training intensity | Active comparator | Exercise Training with moderate intensities consists of a cycling endurance Training at 60% of the individual Peak work rate, resistance Training for 3 sets à 20 repetitions and squats on the floor. Receives: Procedure: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance shuttle walk test (ESWT)
The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.
Measured: Change in the duration of the ESWT from day 1 to day 21
Secondary outcomes (7)
Oxygen saturation
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Measured: Change in the oxygen saturation at isotime from day 1 to day 21
Heart rate
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Measured: Change in the heart rate at isotime from day 1 to day 21
Partial pressure of carbon dioxide (CO2)
Parameter will be measured by Sentec (R) device. Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Measured: Change in the partial pressure of CO2 at isotime from day 1 to day 21
Lactate concentration
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Measured: Change in lactate concentration at isotime from day 1 to day 21
Perceived Dyspnea
Dyspnea will be rated on a 0 to 10-point BORG scale where lower values represent less dyspnea and vice versa. The total score will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Measured: Change in perceived dyspnea at isotime from day 1 to day 21
Strength capacity in knee extension
Strength will be measured by a Hand Held Dynamometer (Microfet (R)).
Measured: Change in strength from day 1 to day 21
Balance performance
absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance
Measured: Change in balance performance from day 1 to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start10 Jan 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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
- Model description
- Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- Investigators
- Klaus Kenn, Prof. Dr., Principal investigator, Schoen Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802357
- Sponsor's protocol ID
- AAT Training
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients
- ClinicalTrials.gov ID
- NCT03802357
- Acronym / sponsor ID
- AAT Training
- Keywords
- Pulmonary rehabilitation, Exercise training, Alpha-1 Antitrypsin deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jan 2019 (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.
Pulmonary rehabilitation (PR) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a 3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)[1]. These between-group differences were mirrored by missing adaptations of the fatigue-resistant skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial because it enables patients for physical endurance activities (walking, cycling etc.) during their daily life.
The aim of this study is to compare the effects of an exercise Training program with high vs. moderate Training intensity in order to find a Training modality which improves Training effects in A1ATD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
| Arm | Type | Receives |
|---|---|---|
| High training intensity | Experimental | Procedure: Exercise trainingExercise Training with high intensities consists of a cycling Interval Training at 100% of the individual Peak work rate, resistance Training for 3 sets à 8 repetitions and squats on a Vibration plate. |
| moderate training intensity | Active comparator | Procedure: Exercise trainingExercise Training with moderate intensities consists of a cycling endurance Training at 60% of the individual Peak work rate, resistance Training for 3 sets à 20 repetitions and squats on the floor. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD patients with A1ATD (genotype PiZZ)
- COPD patients without A1ATD (genotype PiMM)
- Global initiative for chronic obstructive lung disease (GOLD) stage III-IV
- Medical Treatment according to recent A1ATD guidelines
Key exclusion criteria (3 listed)
- General exclusion criteria for physical Training such as acute coronary Syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic comorbidities which prevent patients from participating in exercise Training program.
- No written informed consent
- Non-compliance
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 |
|---|---|---|
| Exercise trainingPatients perform an exercise Training program of 3 weeks Duration including endurance Training, resistance Training and squat Training. This program is part of an inpatient pulmonary Rehabilitation. | Procedure or surgery | High training intensity, moderate training intensity |
Primary outcome
Endurance shuttle walk test (ESWT)
Time frame: Change in the duration of the ESWT from day 1 to day 21
The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.
7 secondary outcomes
Oxygen saturation
Time frame: Change in the oxygen saturation at isotime from day 1 to day 21
Heart rate
Time frame: Change in the heart rate at isotime from day 1 to day 21
Partial pressure of carbon dioxide (CO2)
Time frame: Change in the partial pressure of CO2 at isotime from day 1 to day 21
Lactate concentration
Time frame: Change in lactate concentration at isotime from day 1 to day 21
Perceived Dyspnea
Time frame: Change in perceived dyspnea at isotime from day 1 to day 21
Strength capacity in knee extension
Time frame: Change in strength from day 1 to day 21
Balance performance
Time frame: Change in balance performance from day 1 to day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Klaus Kenn, Prof. Dr. principal investigator
Schoen Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Chronic Obstructive Pulmonary Disease and Alpha 1-Antitrypsin Deficiency, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Kenn, Prof. Dr. (0865293 ext. 1540, kkenn@schoen-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance shuttle walk test (ESWT) (time frame: Change in the duration of the ESWT from day 1 to day 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 16 Jan 2019.