NCT03735615

Brief Summary

Exercise therapy is a cornerstone in the management of patients with Chronic Obstructive Pulmonary disease (COPD), and supervised walking exercise three times a week over 12 weeks improves walking ability and quality of life. Despite this, very few patients exercise on a regular basis. The underuse of exercise in COPD patients can partly be explained by discomfort during exercise because it evokes dyspnea, and thereby explain lack of participation in exercise. If the goal is to offer the best medical therapy to these patients, new and effective exercise training methods must be explored and defined since exercise training is an important part of pulmonary rehabilitation. Intention is to study a new training method called sprint interval training (SIT), which consists of high intensity bouts with very short duration. The idea behind SIT is to avoid the dyspnea associated with traditional endurance training, thus maximizing exercise power without excessive discomfort. The investigators will study training adaptations in patients with COPD and compare the results with age-matched controls. It is expected that both COPD-patients and healthy elderly will improve exercise cycle time until exhaustion after SIT training, and also that the improvement will be larger in the healthy group due to higher absolute training intensity.

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 Nov 2018

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

November 7, 2018

Last Update Submit

January 9, 2020

Conditions

Keywords

Exercise therapyHigh-Intensity Interval Training

Outcome Measures

Primary Outcomes (1)

  • exercise cycle time to exhaustion

    3 weeks

Study Arms (2)

chronic obstructive lung disease

EXPERIMENTAL
Behavioral: sprint interval training

healthy control

EXPERIMENTAL
Behavioral: sprint interval training

Interventions

Each training session will be performed 3 times per week for 3 weeks. Each session consists of 3-5x20 sec all-out cycling efforts against a load corresponding to 0.05-0.07 kg/kg body mass, separated by 3-5 min of low intensity cycling (20-50 W), on a lode bicycle ergometer (Excalibur Sport V2.0, Groningen, the Netherlands). All training sessions includes a 5 min warm-up and 3 min cool-down.

chronic obstructive lung diseasehealthy control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable CPOD stage 3 and 4 according to GOLD guidelines (www.goldcopd.org)
  • post bronchodilator FEV \< 50%

You may not qualify if:

  • having participated in a pulmonary rehabilitation program during the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øystein Risa, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 10 patients with stable chronic obstructive lung disease (COPD) stage 3 and 4 according to GOLD guidelines (www.goldcopd.org), recruited from outpatient ward of the Lung Department at St Olav University Hospital. Control group of 10 age-matched but otherwise healthy subjects
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

November 15, 2018

Primary Completion

March 10, 2019

Study Completion

March 10, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations