NCT00658853

Brief Summary

4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

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

January 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

April 10, 2008

Last Update Submit

July 15, 2016

Conditions

Pulmonary Disease, Chronic ObstructiveHyperoxia

Keywords

COPDtrainingVO2peakperformanceventilationhigh aerobic intensity treadmill walkingone leg training by cycling

Outcome Measures

Primary Outcomes (4)

  • VO2peak

    10 weeks

  • Ventilation

    10 weeks

  • FEV1

    10 weeks

  • Walking performance

    10 weeks

Secondary Outcomes (2)

  • Quality of life

    3 months

  • SPSS

    3 months

Study Arms (3)

1

ACTIVE COMPARATOR

High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a 5% graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.

Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling

2

ACTIVE COMPARATOR

4 times 4 minutes interval training in hyperoxia - 100% oxygen

Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling

3

ACTIVE COMPARATOR

One leg at a time training 4 times 4 minutes interval training using cycling ergometer

Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling

Interventions

4 times 4 minutes high aerobic intensity one leg cyclingBEHAVIORAL

3 times per week for 10 weeks

123

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD

You may not qualify if:

  • Heart disease
  • Walking or cycling inabilities
  • Other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, NO-7489, Norway

Location

Related Publications (1)

  • Bjorgen S, Helgerud J, Husby V, Steinshamn S, Richadson RR, Hoff J. Aerobic high intensity one-legged interval cycling improves peak oxygen uptake in chronic obstructive pulmonary disease patients; no additional effect from hyperoxia. Int J Sports Med. 2009 Dec;30(12):872-8. doi: 10.1055/s-0029-1238292.

    PMID: 19821224RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHyperoxiaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsRespiration Disorders

Study Officials

  • Jan Helgerud, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 15, 2008

Study Start

January 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

NO(1)