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:


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
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, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014