Long Term Physical Training in Asthma

March 31, 2010 updated by: Universitätsklinikum Hamburg-Eppendorf

Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General quality of life
Time Frame: One year
Assessment of general quality of life using the german version of the SF-36 questionaire.
One year
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)
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Andreas Meyer, M.D., Kliniken Mariahilf GmbH, Mönchengladbach, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Primary Completion (Actual)

January 1, 1998

Study Completion (Actual)

March 1, 1998

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

March 31, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Estimate)

April 1, 2010

Last Update Submitted That Met QC Criteria

March 31, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-001 (TheraBionic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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