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

NCT03802357 | Unknown

• 1 other identifier: AAT Training
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Alpha 1-Antitrypsin Deficiency

Keywords

Pulmonary rehabilitation; Exercise training; Alpha-1 Antitrypsin deficiency

Outcome Measures

Primary Outcomes (1)

• Endurance shuttle walk test (ESWT)

  The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.

  Change in the duration of the ESWT from day 1 to day 21

Secondary Outcomes (7)

• Oxygen saturation

  Change in the oxygen saturation 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

• 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

Study Arms (2)

High training intensity

EXPERIMENTAL

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

moderate training intensity

ACTIVE COMPARATOR

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

Interventions

Exercise training 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.

High training intensity; moderate training intensity

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No written informed consent
• Non-compliance

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; alpha 1-Antitrypsin Deficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Klaus Kenn, Prof. Dr.

  Schoen Klinik Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Kenn, Prof. Dr.

CONTACT

0865293; kkenn@schoen-klinik.de

Inga Jarosch, Dr.

CONTACT

0865293; ijarosch@schoen-klinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician

Model Details: Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: January 10, 2019
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)