Exercise Training in Chronic Obstructive Pulmonary Diseas... | NCT01218282

Studies
Exercise Training in Chronic Obstructive Pulmonary Disease (COPD)

NCT01218282

Sponsor

Università degli Studi di Ferrara

Status

Completed

Last Update Posted

Oct 27, 2010Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Home exercise training
NO Exercise Training

Countries

Italy

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

Oct 2010

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

Jan 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Oct 7, 2010

First Submission Date that Met QC Criteria

Oct 8, 2010

First Posted Date

Oct 11, 2010Estimated

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

Oct 26, 2010

Last Update Posted Date

Oct 27, 2010Estimated

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

Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity.

This study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in COPD patients. Outcome: exercise performance, daily physical activity and respiratory function.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home Exercise Training Group A1	Experimental	Patients assigned to this arm maintain the prescribed walking speed during the training with a metronome	Behavioral: Home exercise training
Home Exercise Training Group A2	Experimental	Patients assigned to this arm cover a fixed distance in a given period of time.	Behavioral: Home exercise training
Control	No Intervention		Behavioral: NO Exercise Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home exercise training	Behavioral	20-30 min/day for at least 4 days/week	Home Exercise Training Group A1 Home Exercise Training Group A2

Measure	Description	Time Frame
Exercise Capacity		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.

Exclusion Criteria:

COPD patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annalisa Cogo, MD	Università degli Studi di Ferrara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary respiratory unit- University Hospital		Ferrara	Ferrara	44100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided