Alpha 1-Antitrypsin Deficiency, Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Pulmonary rehabilitation, Exercise training, Alpha-1 Antitrypsin deficiency
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.
Interventions
PROCEDUREExercise training
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.
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endurance shuttle walk test (ESWT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Change in the heart rate at isotime from day 1 to day 21 | Outcome will be assessed at the the time Point of the end of the shortest ESWT (isotime). |
| Partial pressure of carbon dioxide (CO2) | Change in the partial pressure of CO2 at isotime from day 1 to day 21 | 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). |
| Lactate concentration | Change in lactate concentration at isotime from day 1 to day 21 | Outcome will be assessed at the the time Point of the end of the shortest ESWT (isotime). |
| Oxygen saturation | Change in the oxygen saturation at isotime from day 1 to day 21 | Outcome will be assessed at the the time Point of the end of the shortest ESWT (isotime). |
| Strength capacity in knee extension | Change in strength from day 1 to day 21 | Strength will be measured by a Hand Held Dynamometer (Microfet (R)). |
| Balance performance | Change in balance performance from day 1 to day 21 | absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance |
| Perceived Dyspnea | Change in perceived dyspnea at isotime from day 1 to day 21 | 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). |
Countries
Germany
Contacts
Primary ContactKlaus Kenn, Prof. Dr.
Backup ContactInga Jarosch, Dr.
Outcome results
None listed