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

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ClinicalTrials.gov Identifier: NCT03802357
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, 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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Alpha 1-Antitrypsin Deficiency Procedure: Exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: High training intensity
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.
Procedure: Exercise 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.

Active Comparator: moderate training intensity
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.
Procedure: Exercise 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.




Primary Outcome Measures :
  1. Endurance shuttle walk test (ESWT) [ Time Frame: 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 :
  1. Oxygen saturation [ Time Frame: 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").

  2. Heart rate [ Time Frame: 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").

  3. Partial pressure of carbon dioxide (CO2) [ Time Frame: 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").

  4. Lactate concentration [ Time Frame: 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").

  5. Perceived Dyspnea [ Time Frame: 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").

  6. Strength capacity in knee extension [ Time Frame: Change in strength from day 1 to day 21 ]
    Strength will be measured by a Hand Held Dynamometer (Microfet (R)).

  7. Balance performance [ Time Frame: 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802357


Contacts
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Contact: Klaus Kenn, Prof. Dr. 0865293 ext 1540 kkenn@schoen-klinik.de
Contact: Inga Jarosch, Dr. 0865293 ext 1730 ijarosch@schoen-klinik.de

Locations
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Germany
Schoen Klinik Berchtesgadener Land Recruiting
Schönau Am Königssee, Germany, 83471
Contact: Klaus Kenn, Prof. Dr.    0865293 ext 1540    kkenn@schoen-klinik.de   
Contact: Inga Jarosch, Dr.    0865293 ext 1730    ijarosch@schoen-klinik.de   
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Investigators
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Principal Investigator: Klaus Kenn, Prof. Dr. Schoen Klinik Berchtesgadener Land
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Responsible Party: Klaus Kenn, Head physician, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT03802357    
Other Study ID Numbers: AAT Training
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Kenn, Schön Klinik Berchtesgadener Land:
Pulmonary rehabilitation
Exercise training
Alpha-1 Antitrypsin deficiency
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Liver Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes