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Effects of Regular Exercise on Adult Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Exercise, Asthma control, Physical fitness, Quality of life

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Asthma control
Asthma control based on symptom score and PEF-values

Secondary Outcome Measures

Physical fitness
Physical fitness measured with spiroergometry

Full Information

First Posted
May 30, 2013
Last Updated
May 10, 2017
Sponsor
University of Oulu
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
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1. Study Identification

Unique Protocol Identification Number
NCT02012400
Brief Title
Effects of Regular Exercise on Adult Asthma
Official Title
Effects of Regular Exercise on Physical Fitness, Asthma Control and Quality of Life of Adult Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Exercise, Asthma control, Physical fitness, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma control
Description
Asthma control based on symptom score and PEF-values
Time Frame
6-month period
Secondary Outcome Measure Information:
Title
Physical fitness
Description
Physical fitness measured with spiroergometry
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Lung function
Description
Lung function measured with spirometry
Time Frame
Baseline and 6 months
Title
Quality of Life
Description
Quality of life assessed using St. Georges Respiratory Questionnaire
Time Frame
Baseline and 6 months
Title
Step test
Description
Indirect maximal oxygen consumption test using with 6 min step-walk-test
Time Frame
Baseline and 6 months
Title
Muscle strength and flexibility
Description
Muscle strength and flexibility tests
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center for Environmental and Respiratory Health Research, University of Oulu
City
Oulu
ZIP/Postal Code
90014
Country
Finland

12. IPD Sharing Statement

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Effects of Regular Exercise on Adult Asthma

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