Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients

January 2, 2013 updated by: Norwegian University of Science and Technology

Effects of Aerobe Interval Training and Moderate Continuous Training in COPD Patients

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Reduced exercise tolerance is one of the hallmarks of COPD and The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contributes to this impairment . Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction

Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation. It is still uncertain what type of endurance training that is most favourable for COPD patients.

In patients with heart failure and metabolic syndrome aerobe interval exercise have be shown to be superior in improving aerobic capacity and cardiac function

We therefore want conduct a study comparing training effects in patients with moderate to severe COPD, that participated in an identical training program that in HF and metabolic syndrome patients gave significant improvement in aerobic capacity, cardiac function and skeletal muscle function.

Patients will therefore be assigned to either 4x4 minutes high intensity interval treadmill exercise or continuous moderate intensity treadmill exercise 3 times pr week for 12 weeks. Aerobic capacity and work economy, pulmonary,cardiac and skeletal muscle function before and after the exercise training will be measured.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7089
        • Department of circulation and medical imaging , NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Aerobe Interval Training
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
  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
Other Names:
  • non
Active Comparator: Moderate Continous Training
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
  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
Other Names:
  • non

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
VO2-peak
Time Frame: At inclusion and after 12 weeks of exercise training
At inclusion and after 12 weeks of exercise training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cardiac function
Time Frame: At inclusion and after 12 weeks of exercise training
At inclusion and after 12 weeks of exercise training
Skeletal muscle function
Time Frame: At inclusion and after 12 weeks of exercise training
At inclusion and after 12 weeks of exercise training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sigurd Steinshamn, MD PhD, NTNU , Trondheim
  • Principal Investigator: Eivind Brønstad, MD, NTNU, Trondheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 42008754

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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