Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

NCT01380626 | Completed

• 1 other identifier: AAT2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.

Conditions

Chronic Obstructive Pulmonary Disease; Alpha-1-antitrypsin-deficiency

Keywords

alpha-1-antitrypsin-deficiency; COPD; exercise training; muscle biopsy

Outcome Measures

Primary Outcomes (1)

• aerobic and anaerobic enzymes

  changes in quantity of enzymes from baseline to day 23

  day 2 and 23

Secondary Outcomes (2)

• maximal exercise capacity in incremental cycling test

  day 2 and 23

• 6-minute-walking distance

  day 3 and 24

Study Arms (1)

exercise training

EXPERIMENTAL

Procedure: exercise training

Interventions

exercise training PROCEDURE

strength and endurance training, 5 time per week.

Also known as: endurance training, strength training

exercise training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD
• Alpha-1-Antitrypsine-deficiency, phenotype: ZZ
• FEV1%pred. \<50

You may not qualify if:

• acute exacerbation
• exacerbation in the last 4 weeks

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• Grifols Therapeutics LLC: collaborator
• Alpha-1 Foundation: collaborator

Study Sites (1)

Klinikum Berchtesgadener Land

Berchtesgaden, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; alpha 1-Antitrypsin Deficiency

Interventions

Exercise; Endurance Training; Resistance Training

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; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Klaus Kenn, Dr. med.

  Klinikum Berchtesgadener Land, Schön Klinik

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician (department of pneumology)

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: February 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

DE (1)