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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02012400
Other study ID # mjaakkola-001
Secondary ID
Status Completed
Phase N/A
First received May 30, 2013
Last updated May 10, 2017
Start date August 2011
Est. completion date June 30, 2015

Study information

Verified date May 2017
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of regular exercise on physical fitness, asthma control, and quality of life among adult asthmatics.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date June 30, 2015
Est. primary completion date June 30, 2015
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- diagnosis of asthma made by physician, or reimbursement for asthma medication from the National Social Insurance Institution of Finland (code 203), or patient fulfills the diagnostic criteria for asthma as outlined in the Finnish Guidelines for Asthma Management (Käypä hoito -suositus 2006 and 2012)

Exclusion Criteria:

- FEV1 < 60 % of predicted in spirometry

- PEF variability > 30 % at least 2 times during a 1-week monitoring period

- use of bronchodilating medication at least 4 times daily

- permanent, daily steroid tablet treatment

- patients who exercise regularly already at baseline at least 3 times a week at least 30 min at a time

- serious coronary heart disease

- severe hypotension

- severe heart failure

- severe musculoskeletal disorder

- dementia

- physician-diagnosed chronic obstructive lung disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
The exercise group is given a 24-week individualized training program, including aerobic exercise, muscular training, relaxation exercises and stretching. Patients are asked to observe their asthma control daily and to mark in their diary asthma symptoms and activity limitations as well as duration, intensity and form of exercising on daily basis. They are also asked to perform PEF-measurements twice a day for one-week period every 4 weeks. The control group receives ordinary instructions.

Locations

Country Name City State
Finland Center for Environmental and Respiratory Health Research, University of Oulu Oulu

Sponsors (8)

Lead Sponsor Collaborator
University of Oulu Foundation of the Finnish Anti-Tuberculosis Association, GlaxoSmithKline, Ida Montin Foundation, Jalmari and Rauha Ahokas Foundation, Oulu University Hospital, Research Foundation of the Pulmonary Diseases, Vaino and Laina Kivi Foundation

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Lung function Lung function measured with spirometry Baseline and 6 months
Other Quality of Life Quality of life assessed using St. Georges Respiratory Questionnaire Baseline and 6 months
Other Step test Indirect maximal oxygen consumption test using with 6 min step-walk-test Baseline and 6 months
Other Muscle strength and flexibility Muscle strength and flexibility tests Baseline and 6 months
Primary Asthma control Asthma control based on symptom score and PEF-values 6-month period
Secondary Physical fitness Physical fitness measured with spiroergometry Baseline and 6 months
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