ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Physical Training in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01097473
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : April 1, 2010
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Asthma Procedure: Exercise training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics
Study Start Date : April 1996
Actual Primary Completion Date : January 1998
Actual Study Completion Date : March 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Exercise training
Subjects participate in a once weekly supervised exercise training group, duration of 60 min.
Procedure: Exercise training
Exercise training in outpatient sport groups once weekly with a duration of 60 min each
No Intervention: Control
Control group receives no intervention



Primary Outcome Measures :
  1. Maximum oxygen uptake [ Time Frame: One year ]
    Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.


Secondary Outcome Measures :
  1. General quality of life [ Time Frame: One year ]
    Assessment of general quality of life using the german version of the SF-36 questionaire.

  2. Disease-specific quality of life [ Time Frame: One year ]
    Assessment of the disease-specific quality of life using the Asthma Quality of Life Questionnaire (AQLQ)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097473


Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Andreas Meyer, M.D. Kliniken Mariahilf GmbH, Mönchengladbach, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andreas Meyer, Krankenhaus St. Kamillus, Mönchengladbach, Germany
ClinicalTrials.gov Identifier: NCT01097473     History of Changes
Other Study ID Numbers: AM-001
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: April 1, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases