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Long Term Physical Training in Asthma

This study has been completed.
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01097473
First received: March 31, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention
Asthma
 Procedure: Exercise training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Maximum oxygen uptake [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: No ]
    Assessment of general quality of life using the german version of the SF-36 questionaire.

  • Disease-specific quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
    Assessment of the disease-specific quality of life using the Asthma Quality of Life Questionnaire (AQLQ)


Enrollment: 24
Study Start Date: April 1996
Study Completion Date: March 1998
Primary Completion Date: January 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Andreas Meyer, Krankenhaus St. Kamillus, Mönchengladbach, Germany
ClinicalTrials.gov Identifier: NCT01097473     History of Changes
Other Study ID Numbers: AM-001
Study First Received: March 31, 2010
Last Updated: March 31, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 21, 2013