Chronic Obstructive Pulmonary DiseaseNCT02915614
Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al., 2016, DOI: 10.1159/000449509). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2017to Jan 2024
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic obstructive pulmonary disease
- phenotype PiMM or PiZZ
- written informed consent
Who cannot join
- any comorbidities that prevent patients from participating in an exercise Training program
- necessity of anticoagulant therapy
- other genetic variants of alpha-1 antitrypsin than PiMM or PiZZ
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, 83471
Inga Jarosch, 0049-8652-931730, ijarosch@schoen-kliniken.de
About this study
Official title: Effects of Pulmonary Rehabilitation on Skeletal Muscle Morphology and Metabolism in PiMM vs. PiZZ COPD Patients
In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al., 2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise capacity compared to PiMM patients. This latter finding was mirrored by an increase of oxidative myofiber type I proportion - that is important for aerobic exercises in daily life - in PiMM but not PiZZ patients.
Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to compare the effects of pulmonary rehabilitation including exercise training on a) specific enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b) the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- alpha-1 antitrypsin deficiency, pulmonary rehabilitation, exercise training, skeletal muscle biopsy
- 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.
Pulmonary rehabilitationProcedure or surgery
3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)
| Study group | Role | What they receive |
|---|---|---|
| PiMM patients | Active comparator | COPD patients with the Alpha-1 antitrypsin genetic variant "PiMM" (Smoking-related COPD) Receives: Procedure: Pulmonary rehabilitation |
| PiZZ patients | Experimental | COPD patients with alpha-1 antitrypsin deficiency (genotype PiZZ) Receives: Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Will be measured during a constant work rate cycling test
Measured: 3 weeks
Secondary outcomes (3)
Myofibre type I Distribution
Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle
Measured: 3 weeks
Capillary to fibre ratio
Skeletal muscle sample will be taken from the M.vastus lateralis via Bergström muscle biopsy needle
Measured: 3 weeks
muscle strength
strength test in the right knee Extensor and flexor
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start2 Mar 2017
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof., Principal investigator, Department of respiratory medicine, Schoen Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915614
- Sponsor's protocol ID
- AAT 2016
- Status last verified
- Nov 2022
- First submitted
- 21 Sep 2016
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Skeletal Muscle Morphology and Metabolism in PiMM vs. PiZZ COPD Patients
- ClinicalTrials.gov ID
- NCT02915614
- Acronym / sponsor ID
- AAT 2016
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- alpha-1 antitrypsin deficiency, pulmonary rehabilitation, exercise training, skeletal muscle biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 27 Sep 2016 (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.
In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous deficient variant (PiZZ) (Jarosch et al., 2016, DOI: 10.1159/000449509). PiZZ COPD patients showed less improvement in exercise capacity compared to PiMM patients. This latter finding was mirrored by an increase of oxidative myofiber type I proportion - that is important for aerobic exercises in daily life - in PiMM but not PiZZ patients.
Based on this finding of impaired skeletal muscle adaptation, the aim of this study is to compare the effects of pulmonary rehabilitation including exercise training on a) specific enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b) the analogue gene expression of these oxidative enzymes in a cohort of PiMM and PiZZ COPD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PiMM patients | Active comparator | Procedure: Pulmonary rehabilitationCOPD patients with the Alpha-1 antitrypsin genetic variant "PiMM" (Smoking-related COPD) |
| PiZZ patients | Experimental | Procedure: Pulmonary rehabilitationCOPD patients with alpha-1 antitrypsin deficiency (genotype PiZZ) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic obstructive pulmonary disease
- phenotype PiMM or PiZZ
- written informed consent
Key exclusion criteria (3 listed)
- any comorbidities that prevent patients from participating in an exercise Training program
- necessity of anticoagulant therapy
- other genetic variants of alpha-1 antitrypsin than PiMM or PiZZ
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 |
|---|---|---|
| Pulmonary rehabilitation3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training) | Procedure or surgery | PiMM patients, PiZZ patients |
Primary outcome
Endurance time
Time frame: 3 weeks
Will be measured during a constant work rate cycling test
3 secondary outcomes
Myofibre type I Distribution
Time frame: 3 weeks
Capillary to fibre ratio
Time frame: 3 weeks
muscle strength
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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. principal investigator
Department of respiratory medicine, 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 Pulmonary rehabilitation 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 3 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 30 Nov 2022. 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 Inga Jarosch (+49865293 ext. 1730, ijarosch@schoen-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time (time frame: 3 weeks). 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 30 Nov 2022.