Long Term Physical Training in Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097473
• Other study ID #: AM-001
• Status: Completed
• Phase: N/A
• First received: March 31, 2010
• Last updated: March 31, 2010
• Start date: April 1996
• Est. completion date: March 1998

Study information

• Verified date: March 2010
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1998
• Est. primary completion date: January 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Exercise training
Exercise training in outpatient sport groups once weekly with a duration of 60 min each

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen uptake	Maximum oxygen uptake measured during unsteady state cycle ergometer test with work increments of 10 watts each minute until exhaustion.	One year	No
Secondary	General quality of life	Assessment of general quality of life using the german version of the SF-36 questionaire.	One year	No
Secondary	Disease-specific quality of life	Assessment of the disease-specific quality of life using the Asthma Quality of Life Questionnaire (AQLQ)	One year	No