REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT

March 11, 2021 updated by: Vibeke Backer, Bispebjerg Hospital

REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A Randomized Clinical Trial

To evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in asthmatics.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and undergo 6 months of intervention or usual lifestyle.

Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled corticosteroid, symptomatic and untrained.

At enrollment and during the study asthma medicine is adjusted based on asthma symptoms evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma, subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.

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.
150

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

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Respiratory Research Unit, Birpebjerg Hospital

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asthma (The diagnose of asthma is based on symptoms and at least one positive asthma test the last 5 years (AHR to either mannitol or methacholine, reversibility to beta2-agonist, peak flow variation or positive eucapnic voluntary hyperventilation test))
  • ACQ ≥ 1 and ≤ 2.5
  • On a daily dose of ICS at a minimum of 400 µg budesonide or equivalent ICS for 3 months and with no changes in asthma medicine 4 weeks prior to enrollment
  • Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 month)
  • Capable of exercising on bike

Exclusion Criteria:

  • Unable to speak and understand Danish
  • Infection within 4 weeks prior to visit 100*
  • Asthma exacerbation within 4 weeks prior to visit 100*
  • Hospitalized for an asthma attack during the last 2 months
  • Treatment with immunotherapy within 5 T½ of the treatment drug prior to visit 100
  • Initiation of allergen immunotherapy within 3 months prior to visit 100 or plan to begin therapy during study period
  • Treatment with peroral prednisolone
  • Respiratory: other chronic pulmonary disease of clinically significance
  • Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (NYHA III-IV or EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)
  • Pregnancy or breastfeeding or planned pregnancy within the next 12 months
  • Other inflammatory or metabolic diseases with the exception of rhinitis, atopy and well-controlled hypothyroidism treated with or without Eltroxin
  • Vaccination less than 2 weeks prior to any visit
  • Current or former smokers with > 20 pack years

  • Subjects, who by investigators determination, will not be able to adhere to study protocol

    • If patients are excluded due to a recent infection or exacerbation they can undergo re-screening after a total of 4 weeks after end of exacerbation treatment/clearing the infection.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Training group

Supervised High intensity interval training (HIIT) 3 times a week for 6 months.

Training session:

10 minutes warm up (Low-moderate intensity) 30 minutes intervention (16 minutes HIIT) 10 minutes cool down(Low-moderate intensity)
Behavioral: High Intensity Interval Training
Training (HIIT)
Other Names:
  • Training group
No Intervention: Control group
Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).

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
Measure Description
Time Frame
Reduced inhaled corticosteroid (ICS) 6 months
Time Frame: 6 months +/- 7 days
The proportion of participants at 6 months that have been down-titrated in ICS dose by at least 25% compared to the participants' baseline dose
6 months +/- 7 days

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
Measure Description
Time Frame
Reduced inhaled corticosteroid (ICS) 12 months
Time Frame: 12 months +/- 7 days
The proportion of participants at 12 months that have been down-titrated in ICS dose by at least 25 % compared to baseline.
12 months +/- 7 days
Cumulated ICS 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in cumulated dose of ICS at 6 months
6 months +/- 7 days
Cumulated ICS 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in cumulated dose of ICS at 12 months
12 months +/- 7 days
Cumulated Long acting beta2 agonists (LABA) 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in cumulated dose of LABA at 6 months
6 months +/- 7 days
Cumulated LABA 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in cumulated dose of LABA at 12 months
12 months +/- 7 days
Exacerbation rate 6 months
Time Frame: 6 months +/- 7 days
Number of exacerbations (moderate-severe) at 6 months
6 months +/- 7 days
Exacerbation rate 12 months
Time Frame: 12 months +/- 7 days
Number of exacerbations (moderate-severe) at 12 months
12 months +/- 7 days
miniAQLQ 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months
6 months +/- 7 days
miniAQLQ 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months
12 months +/- 7 days
Fraction of exhaled Nitrogen Oxid 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in Airway inflammation evaluated by FeNO at 6 months
6 months +/- 7 days
Fraction of exhaled Nitrogen Oxid 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in Airway inflammation evaluated by FeNO at 12 months
12 months +/- 7 days
Sputum cell count 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months
6 months +/- 7 days
Sputum cell count 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months
12 months +/- 7 days
Systemic inflammation 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 6 months
6 months +/- 7 days
Systemic inflammation 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 12 months
12 months +/- 7 days
Airway hyperresponsiveness
Time Frame: 6 months +/- 7 days
Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months
6 months +/- 7 days
FEV1 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in lung function evaluated by FEV1 at 6 months
6 months +/- 7 days
FVC 6 months
Time Frame: 6 months +/- 7 days
Change from baseline in lung function evaluated by FVC at 6 months
6 months +/- 7 days
FEV1 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in lung function evaluated by FEV1 at 12 months
12 months +/- 7 days
FVC 12 months
Time Frame: 12 months +/- 7 days
Change from baseline in lung function evaluated by FVC at 12 months
12 months +/- 7 days
Cardiopulmonary fitness
Time Frame: 6 months +/- 7 days
Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max)
6 months +/- 7 days
Change in fat and muscle composition (DEXA scan)
Time Frame: 6 months +/- 7 days
Change from baseline in fat and muscle composition evaluated by DEXA scan
6 months +/- 7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eosinophilic subpopulation - exploratory analyses 6 months
Time Frame: 6 months +/- 7 days
To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics. Both regarding primary outcome and secondary outcomes.
6 months +/- 7 days
Eosinophilic subpopulation - exploratory analyses 12 months
Time Frame: 12 months +/- 7 days
To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics with regards to secondary outcomes at 12 months.
12 months +/- 7 days

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.
Bispebjerg Hospital

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: Vibeke Backer, professor, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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.
October 13, 2017

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.
June 26, 2020

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.
December 4, 2020

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).
September 18, 2017

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.
September 19, 2017

First Posted (Actual)

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.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

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.
March 15, 2021

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.
March 11, 2021

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.
March 1, 2021

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.
  • REPLACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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