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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Alpha 1-Antitrypsin Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary rehabilitation, Exercise training, Alpha-1 Antitrypsin deficiency

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schoen Klinik Berchtesgadener LandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High training intensity

moderate training intensity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oxygen saturation
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Heart rate
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
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").
Lactate concentration
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
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").
Strength capacity in knee extension
Strength will be measured by a Hand Held Dynamometer (Microfet (R)).
Balance performance
absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance

Full Information

First Posted
January 10, 2019
Last Updated
January 14, 2019
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT03802357
Brief Title
Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients
Official Title
Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Alpha 1-Antitrypsin Deficiency
Keywords
Pulmonary rehabilitation, Exercise training, Alpha-1 Antitrypsin deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High training intensity
Arm Type
Experimental
Arm Description
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.
Arm Title
moderate training intensity
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endurance shuttle walk test (ESWT)
Description
The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.
Time Frame
Change in the duration of the ESWT from day 1 to day 21
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Time Frame
Change in the oxygen saturation at isotime from day 1 to day 21
Title
Heart rate
Description
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Time Frame
Change in the heart rate at isotime from day 1 to day 21
Title
Partial pressure of carbon dioxide (CO2)
Description
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").
Time Frame
Change in the partial pressure of CO2 at isotime from day 1 to day 21
Title
Lactate concentration
Description
Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
Time Frame
Change in lactate concentration at isotime from day 1 to day 21
Title
Perceived Dyspnea
Description
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").
Time Frame
Change in perceived dyspnea at isotime from day 1 to day 21
Title
Strength capacity in knee extension
Description
Strength will be measured by a Hand Held Dynamometer (Microfet (R)).
Time Frame
Change in strength from day 1 to day 21
Title
Balance performance
Description
absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance
Time Frame
Change in balance performance from day 1 to day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Kenn, Prof. Dr.
Phone
0865293
Ext
1540
Email
kkenn@schoen-klinik.de
First Name & Middle Initial & Last Name or Official Title & Degree
Inga Jarosch, Dr.
Phone
0865293
Ext
1730
Email
ijarosch@schoen-klinik.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Prof. Dr.
Organizational Affiliation
Schoen Klinik Berchtesgadener Land
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Klinik Berchtesgadener Land
City
Schönau Am Königssee
ZIP/Postal Code
83471
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Prof. Dr.
Phone
0865293
Ext
1540
Email
kkenn@schoen-klinik.de
First Name & Middle Initial & Last Name & Degree
Inga Jarosch, Dr.
Phone
0865293
Ext
1730
Email
ijarosch@schoen-klinik.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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