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Clinical Trials/NCT03802357
NCT03802357
Unknown
Not Applicable

Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients

Schön Klinik Berchtesgadener Land1 site in 1 country30 target enrollmentJanuary 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Schön Klinik Berchtesgadener Land
Enrollment
30
Locations
1
Primary Endpoint
Endurance shuttle walk test (ESWT)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2019
End Date
December 31, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Klaus Kenn

Head physician

Schön Klinik Berchtesgadener Land

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

Outcomes

Primary Outcomes

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 Outcomes

  • Oxygen saturation(Change in the oxygen saturation at isotime from day 1 to day 21)
  • Lactate concentration(Change in lactate concentration at isotime from day 1 to day 21)
  • Perceived Dyspnea(Change in perceived dyspnea at isotime from day 1 to day 21)
  • Heart rate(Change in the heart rate at isotime from day 1 to day 21)
  • Partial pressure of carbon dioxide (CO2)(Change in the partial pressure of CO2 at isotime from day 1 to day 21)
  • Strength capacity in knee extension(Change in strength from day 1 to day 21)
  • Balance performance(Change in balance performance from day 1 to day 21)

Study Sites (1)

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