Effects of Regular Exercise on Adult Asthma

May 10, 2017 updated by: University of Oulu

Effects of Regular Exercise on Physical Fitness, Asthma Control and Quality of Life of Adult Asthmatics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

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

  • Finland
      • Oulu, Finland, 90014
        • Center for Environmental and Respiratory Health Research, University of Oulu

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control
Time Frame: 6-month period
Asthma control based on symptom score and PEF-values
6-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness
Time Frame: Baseline and 6 months
Physical fitness measured with spiroergometry
Baseline and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: Baseline and 6 months
Lung function measured with spirometry
Baseline and 6 months
Quality of Life
Time Frame: Baseline and 6 months
Quality of life assessed using St. Georges Respiratory Questionnaire
Baseline and 6 months
Step test
Time Frame: Baseline and 6 months
Indirect maximal oxygen consumption test using with 6 min step-walk-test
Baseline and 6 months
Muscle strength and flexibility
Time Frame: Baseline and 6 months
Muscle strength and flexibility tests
Baseline and 6 months

Collaborators and Investigators

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

Sponsor

University of Oulu

Collaborators

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

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.

Helpful Links

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

August 1, 2011

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mjaakkola-001

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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