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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Alpha 1-Antitrypsin Deficiency
• Intervention / Treatment: Procedure: Exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaus Kenn, Prof. Dr.; Phone Number: 1540 0865293; Email: kkenn@schoen-klinik.de
• Study Contact Backup: Name: Inga Jarosch, Dr.; Phone Number: 1730 0865293; Email: ijarosch@schoen-klinik.de

Study Locations

• Germany
  • Schönau Am Königssee, Germany, 83471
    • Recruiting
    • Schoen Klinik Berchtesgadener Land
    • Contact: Klaus Kenn, Prof. Dr.; Phone Number: 1540 0865293; Email: kkenn@schoen-klinik.de
    • Contact: Inga Jarosch, Dr.; Phone Number: 1730 0865293; Email: ijarosch@schoen-klinik.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").	Change in the oxygen saturation at isotime from day 1 to day 21
Heart rate	Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").	Change in the heart rate at isotime from day 1 to day 21
Partial pressure of carbon dioxide (CO2)	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").	Change in the partial pressure of CO2 at isotime from day 1 to day 21
Lactate concentration	Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").	Change in lactate concentration at isotime from day 1 to day 21
Perceived Dyspnea	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").	Change in perceived dyspnea at isotime from day 1 to day 21
Strength capacity in knee extension	Strength will be measured by a Hand Held Dynamometer (Microfet (R)).	Change in strength from day 1 to day 21
Balance performance	absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance	Change in balance performance from day 1 to day 21

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Investigators: Principal Investigator: Klaus Kenn, Prof. Dr., Schoen Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Exercise training; Alpha-1 Antitrypsin deficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Liver Diseases; Genetic Diseases, Inborn; Subcutaneous Emphysema; Emphysema; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Alpha 1-Antitrypsin Deficiency
• Other Study ID Numbers: AAT Training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No