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Long Term Physical Training in Asthma

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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

Tracking Information
First Submitted Date  ICMJE March 31, 2010
First Posted Date  ICMJE April 1, 2010
Last Update Posted Date April 1, 2010
Study Start Date  ICMJE April 1996
Actual Primary Completion Date January 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
  • General quality of life [ Time Frame: One year ]
    Assessment of general quality of life using the german version of the SF-36 questionaire.
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Physical Training in Asthma
Official Title  ICMJE Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Procedure: Exercise training
Exercise training in outpatient sport groups once weekly with a duration of 60 min each
Study Arms  ICMJE
  • Active Comparator: Exercise training
    Subjects participate in a once weekly supervised exercise training group, duration of 60 min.
    Intervention: Procedure: Exercise training
  • No Intervention: Control
    Control group receives no intervention
Publications * Meyer A, Günther 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2010)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1998
Actual Primary Completion Date January 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01097473
Other Study ID Numbers  ICMJE AM-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andreas Meyer, Krankenhaus St. Kamillus, Mönchengladbach, Germany
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Meyer, M.D. Kliniken Mariahilf GmbH, Mönchengladbach, Germany
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP