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

Overview

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.

Full Title of Study: “Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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”).
  • 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”).
  • 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”).
  • 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”).
  • 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”).
  • 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)).
  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Schön Klinik Berchtesgadener Land
  • Provider of Information About this Clinical Study
    • Principal Investigator: Klaus Kenn, Head physician – Schön Klinik Berchtesgadener Land
  • Overall Official(s)
    • Klaus Kenn, Prof. Dr., Principal Investigator, Schoen Klinik Berchtesgadener Land
  • Overall Contact(s)
    • Klaus Kenn, Prof. Dr., 0865293, kkenn@schoen-klinik.de

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