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Long Term Physical Training in Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • physician diagnosed asthma
  • non-smoker
  • stable condition
  • informed consent

Exclusion Criteria:

  • participation in pulmonary rehabilitation in the past 12 months prior to study inclusion
  • unability to attend training sessions on a regular basis for one year
  • symptomatic coronary heart disease
  • uncontrolled heart failure
  • hemodynamically relevant cardiac rhythm disorders
  • hemodynamically relevant cardiac valvular disorders
  • uncontrolled arterial hypertension
  • hypercapnic respiratory failure
  • severe hypoxemia (i.e. PaO2 <50 mm Hg resp. SaO2 <80% at rest)
  • history of decompensated right heart failure
  • pulmonary arterial hypertension (PA mean pressure at rest >20 mm Hg)
  • severe osteoporosis
  • severe airway obstruction (FEV1 <50% predicted, FEV1 <60% predicted following bronchodilatation)
  • maximum work rate of less than 50 watt during ergometer testing
  • uncontrolled asthma
  • COPD exacerbation
  • severe adipositas (BMI >35 kg/m2)

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise training

Control

Arm Description

Subjects participate in a once weekly supervised exercise training group, duration of 60 min.

Control group receives no intervention

Outcomes

Primary Outcome Measures

Maximum oxygen uptake
Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.

Secondary Outcome Measures

General quality of life
Assessment of general quality of life using the german version of the SF-36 questionaire.
Disease-specific quality of life
Assessment of the disease-specific quality of life using the Asthma Quality of Life Questionnaire (AQLQ)

Full Information

First Posted
March 31, 2010
Last Updated
March 31, 2010
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01097473
Brief Title
Long Term Physical Training in Asthma
Official Title
Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
January 1998 (Actual)
Study Completion Date
March 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.
Detailed Description
Physical training is well known to support a healthy lifestyle. Patients with asthma are often unnecessarily restricted of physical activities or avoid exercise due to the unpleasant experience of exercise-induced dyspnea. As a consequence both children and adults with asthma are less fit than their peers. Like in healthy individuals, regular training supports health in asthmatics. In short-term training programs improvements of physical capabilities have been achieved in children and young adults with asthma. Programs of longer durations than 3 months have not been published in controlled trials. Effects of exercise training on quality of life in adult asthmatics are lacking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Active Comparator
Arm Description
Subjects participate in a once weekly supervised exercise training group, duration of 60 min.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group receives no intervention
Intervention Type
Procedure
Intervention Name(s)
Exercise training
Intervention Description
Exercise training in outpatient sport groups once weekly with a duration of 60 min each
Primary Outcome Measure Information:
Title
Maximum oxygen uptake
Description
Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.
Time Frame
One year
Secondary Outcome Measure Information:
Title
General quality of life
Description
Assessment of general quality of life using the german version of the SF-36 questionaire.
Time Frame
One year
Title
Disease-specific quality of life
Description
Assessment of the disease-specific quality of life using the Asthma Quality of Life Questionnaire (AQLQ)
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: physician diagnosed asthma non-smoker stable condition informed consent Exclusion Criteria: participation in pulmonary rehabilitation in the past 12 months prior to study inclusion unability to attend training sessions on a regular basis for one year symptomatic coronary heart disease uncontrolled heart failure hemodynamically relevant cardiac rhythm disorders hemodynamically relevant cardiac valvular disorders uncontrolled arterial hypertension hypercapnic respiratory failure severe hypoxemia (i.e. PaO2 <50 mm Hg resp. SaO2 <80% at rest) history of decompensated right heart failure pulmonary arterial hypertension (PA mean pressure at rest >20 mm Hg) severe osteoporosis severe airway obstruction (FEV1 <50% predicted, FEV1 <60% predicted following bronchodilatation) maximum work rate of less than 50 watt during ergometer testing uncontrolled asthma COPD exacerbation severe adipositas (BMI >35 kg/m2)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Meyer, M.D.
Organizational Affiliation
Kliniken Mariahilf GmbH, Mönchengladbach, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25947010
Citation
Meyer A, Gunther S, Volmer T, Taube K, Baumann HJ. A 12-month, moderate-intensity exercise training program improves fitness and quality of life in adults with asthma: a controlled trial. BMC Pulm Med. 2015 May 7;15:56. doi: 10.1186/s12890-015-0053-8.
Results Reference
derived

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Long Term Physical Training in Asthma

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