A 12 Week Physical Training Programme for Patients With C... | NCT00744484

Studies
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease

NCT00744484

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Mar 7, 2022Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Training in water
Training on land

Countries

Norway

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

ID	Type	Description	Link
17117	Other Identifier	NSD

Status Module

Record Verification Date

Feb 2022

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

Feb 2008Actual

Primary Completion Date

May 2009Actual

Completion Date

Sep 2010Actual

First Submitted Date

Aug 29, 2008

First Submission Date that Met QC Criteria

Aug 29, 2008

First Posted Date

Sep 1, 2008Estimated

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

Feb 18, 2022

Last Update Posted Date

Mar 7, 2022Actual

Name	Class
Helse Nord-Trøndelag HF	OTHER
Nord-Trøndelag University College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 determine whether water based or land based group training is more effective for people with COPD.

Detailed Description

COPD is a more common diagnosis today compared to 20 years ago, and the group is growing fast. The suffering caused by COPD and the financial cost to society is on the increasing. The principal causes of COPD are smoking and inactivity. So far it is poorly understood wich form of exercise is the most effective in training this condition.

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B1	Experimental	B1 - training in water	Behavioral: Training in water
S1	Experimental	S1 - training on land	Behavioral: Training on land

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training in water	Behavioral	45 minutes interval training in water, submaximal intensity, twice a week	B1

Measure	Description	Time Frame
VO2 peak		12 weeks

Measure	Description	Time Frame
Health related quality of life		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD GOLD II
Not taking part in physical activity during the last year

Exclusion Criteria:

COPD GOLD I, III, IV
Pain in the legs that make activity difficult

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 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
Thor Naustdal, MD	Hospital of Levanger / NTNU ISB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Levanger Hosp		Levanger	Nord-Trøndelag	7600	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D014867	Water

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided