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

NCT ID: NCT03802357

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Alpha 1-Antitrypsin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise training

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Exercise training

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* No written informed consent
* Non-compliance
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Head physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Schoen Klinik Berchtesgadener Land

Locations

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Schoen Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Klaus Kenn, Prof. Dr.

Role: CONTACT

0865293 ext. 1540

Inga Jarosch, Dr.

Role: CONTACT

0865293 ext. 1730

Facility Contacts

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Klaus Kenn, Prof. Dr.

Role: primary

0865293 ext. 1540

Inga Jarosch, Dr.

Role: backup

0865293 ext. 1730

Other Identifiers

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AAT Training

Identifier Type: -

Identifier Source: org_study_id

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