Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Alpha 1-Antitrypsin Deficiency
• Interventions: Procedure: Exercise training

• Registration Number: NCT03802357
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-10
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High training intensity	Exercise training	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.
moderate training intensity	Exercise training	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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").
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").
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").
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").
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

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany