Effects of Regular Exercise on Adult Asthma | NCT02012400

Studies
Effects of Regular Exercise on Adult Asthma

NCT02012400

Sponsor

University of Oulu

Status

Completed

Last Update Posted

May 11, 2017Actual

Enrollment

131Actual

Phase

Not Applicable

Conditions

Asthma

Interventions

Exercise

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

May 30, 2013

First Submission Date that Met QC Criteria

Dec 9, 2013

First Posted Date

Dec 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 11, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY
Foundation of the Finnish Anti-Tuberculosis Association	UNKNOWN
Research Foundation of the Pulmonary Diseases	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental		Other: Exercise
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Lung function	Lung function measured with spirometry	Baseline and 6 months
Quality of Life	Quality of life assessed using St. Georges Respiratory Questionnaire

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Environmental and Respiratory Health Research, University of Oulu		Oulu		90014	Finland

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D009043	Motor Activity

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided