Clinical trial NCT03802357: Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients
Official title: Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Alpha 1-Antitrypsin Deficiency
Keywords: Pulmonary rehabilitation
Exercise training
Alpha-1 Antitrypsin deficiency
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Endurance shuttle walk test (ESWT)
timeFrame: Change in the duration of the ESWT from day 1 to day 21
Secondary outcomes:
measure: Oxygen saturation
timeFrame: Change in the oxygen saturation at isotime from day 1 to day 21
measure: Heart rate
timeFrame: Change in the heart rate at isotime from day 1 to day 21
measure: Partial pressure of carbon dioxide (CO2)
timeFrame: Change in the partial pressure of CO2 at isotime from day 1 to day 21
measure: Lactate concentration
timeFrame: Change in lactate concentration at isotime from day 1 to day 21
measure: Perceived Dyspnea
timeFrame: Change in perceived dyspnea at isotime from day 1 to day 21
measure: Strength capacity in knee extension
timeFrame: Change in strength from day 1 to day 21
measure: Balance performance
timeFrame: Change in balance performance from day 1 to day 21
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
Study officials:
affiliation: Schoen Klinik Berchtesgadener Land
name: Klaus Kenn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: