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

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Brief Title

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

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.
    



Study Type

Interventional


Primary Outcome

Endurance shuttle walk test (ESWT)

Secondary Outcome

 Oxygen saturation

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Exercise training

Study Arms / Comparison Groups

 High training intensity
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

January 10, 2019

Completion Date

December 31, 2021

Primary Completion Date

October 31, 2021

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
      

Gender

All

Ages

40 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Klaus Kenn, Prof. Dr., 0865293, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03802357

Organization ID

AAT Training


Responsible Party

Principal Investigator

Study Sponsor

Schön Klinik Berchtesgadener Land


Study Sponsor

Klaus Kenn, Prof. Dr., Principal Investigator, Schoen Klinik Berchtesgadener Land


Verification Date

January 2019