Effects of Regular Exercise on Adult Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Oulu
Sponsor:
Collaborators:
GlaxoSmithKline
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
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT02012400
First received: May 30, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Asthma
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Regular Exercise on Physical Fitness, Asthma Control and Quality of Life of Adult Asthmatics

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Asthma control [ Time Frame: 6-month period ] [ Designated as safety issue: No ]
    Asthma control based on symptom score and PEF-values


Secondary Outcome Measures:
  • Physical fitness [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Physical fitness measured with spiroergometry


Other Outcome Measures:
  • Lung function [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Lung function measured with spirometry

  • Quality of Life [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Quality of life assessed using St. Georges Respiratory Questionnaire

  • Step test [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Indirect maximal oxygen consumption test using with 6 min step-walk-test

  • Muscle strength and flexibility [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Muscle strength and flexibility tests


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02012400

Contacts
Contact: Maritta S. Jaakkola, MD, PhD +35883155643 maritta.jaakkola@oulu.fi

Locations
Finland
Center for Environmental and Respiratory Health Research, University of Oulu Recruiting
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
GlaxoSmithKline
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
Oulu University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02012400     History of Changes
Other Study ID Numbers: -
Study First Received: May 30, 2013
Last Updated: December 9, 2013
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by University of Oulu:
Asthma
Exercise
Asthma control
Physical fitness
Quality of life

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014