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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03802357
• Other study ID #: AAT Training
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2019
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: Klaus Kenn, Prof. Dr.
• Phone: 0865293
• Email: kkenn[@]schoen-klinik.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schönau Am Königssee

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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