NCT00908765

Brief Summary

Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is poorly understood which form of exercise is the most effective in training this condition. The investigators want to study the physiological response to two different training programs (High intensity aerobe interval training and moderate continuous aerobe training)with special focus on cardiac and skeletal muscle adaptions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

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, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

April 20, 2009

Last Update Submit

January 2, 2013

Conditions

COPDChronic Obstructive Pulmonary Disease

Keywords

Exercise Training COPD

Outcome Measures

Primary Outcomes (1)

  • VO2-peak

    At inclusion and after 12 weeks of exercise training

Secondary Outcomes (2)

  • Cardiac function

    At inclusion and after 12 weeks of exercise training

  • Skeletal muscle function

    At inclusion and after 12 weeks of exercise training

Study Arms (2)

Aerobe Interval Training

ACTIVE COMPARATOR

High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.

Behavioral: Exercise

Moderate Continous Training

ACTIVE COMPARATOR

Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

1. High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. 2. Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks

Also known as: non
Aerobe Interval TrainingModerate Continous Training

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD with FEV1 25-60 % of exp , FEV1%FVC\<70 %. Age 45-80 years

You may not qualify if:

  • Heart failure
  • symptomatic coronary artery disease
  • cancer
  • alcohol and drug abuse
  • severe mental illness
  • Lower respiratory infection last 4 weeks
  • participation in exercise- or lung rehabilitation program last 3 months.
  • oral steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging , NTNU

Trondheim, Trondheim, 7089, Norway

Location

Related Publications (1)

  • Bronstad E, Tjonna AE, Rognmo O, Dalen H, Heggli AM, Wisloff U, Ingul CB, Steinshamn S. Aerobic exercise training improves right- and left ventricular systolic function in patients with COPD. COPD. 2013 Jun;10(3):300-6. doi: 10.3109/15412555.2012.745843. Epub 2012 Dec 28.

    PMID: 23272664RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sigurd Steinshamn, MD PhD

    NTNU , Trondheim

    PRINCIPAL INVESTIGATOR

  • Eivind Brønstad, MD

    NTNU, Trondheim

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2009

First Posted

May 27, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

September 1, 2009

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

NO(1)