NCT02012400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

May 30, 2013

Last Update Submit

May 10, 2017

Conditions

Asthma

Keywords

AsthmaExerciseAsthma controlPhysical fitnessQuality of life

Outcome Measures

Primary Outcomes (1)

  • Asthma control

    Asthma control based on symptom score and PEF-values

    6-month period

Secondary Outcomes (1)

  • Physical fitness

    Baseline and 6 months

Other Outcomes (4)

  • Lung function

    Baseline and 6 months

  • Quality of Life

    Baseline and 6 months

  • Step test

    Baseline and 6 months

  • +1 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Exercise

Control group

NO INTERVENTION

Interventions

ExerciseOTHER

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.

Intervention group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Environmental and Respiratory Health Research, University of Oulu

Oulu, 90014, Finland

Location

MeSH Terms

Conditions

AsthmaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2013

First Posted

December 16, 2013

Study Start

August 1, 2011

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

FI(1)