Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD (COPDEX)

August 12, 2024 updated by: Ronan Berg, Rigshospitalet, Denmark

Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD: a Randomized Controlled Trial (the COPDEX Study)

The aim of this prospective randomised controlled trial in which the impact of high intensity interval training (HIIT) on pulmonay blood volume, pulmonary gas exchange during exercise, and lung tissue mass.

The primary objective is to investigate whether 6 months of supervised HIIT leads to an increase in pulmonary blood volume in patients with COPD with a concomitant improvement in pulmonary gas exchange.

Key objectives are to determine whether an increase in pulmonary blood volume is associated with the formation of new lung tissue. Other secondary objectives include investigating the effect of supervised HIIT on formation of lung tissue, symptom severity, pulmonary gas exchange at supine rest and on pulmonary blood volume at rest. Finally, exploratory objectives include investigating the effects of HIIT on lung function, V̇O2peak, functional outcomes, body composition, blood samples and cardiac output.

Participants will be randomly allocated (1:1) stratified by sex to either

  1. 24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or
  2. A control group who will not undergo HIIT training. The control group will be encouraged not to change their exercise or eating habits.

The participants will visit the clinic pre- and post the intervention. Exercise habits, adverse events, hospital admisseions, infections and medications will be assessed by phone at week 4, 8, 12, 16, 20 and at follow-up visit. All participants will undergo 24-h accelerometry for five consecutive days to measure posture allocation and daily physical activity behavior. The devices will be attached just before the randomization, after one month, at 12 weeks and just before the 6 months testing.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
66

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Men and women
  • Age >=40 and <80 years
  • COPD (GOLD stage I to III)
  • Modified Medical Research Council score (mMRC) of 0 to 3
  • Resting arterial oxygenation > 90% Exclusion criteria
  • Symptoms of ischaemic heart disease
  • Known heart failure
  • Unable to complete or understand HIIT training
  • Claudication
  • Symptoms of disease within 2 weeks prior to the study
  • Participation in pulmonary rehabilitation within 3 months
  • Known malignant disease
  • Pregnancy
  • Unstable cardiac arrhythmic disease

  • Renal or liver dysfunction

    • Known chronic kidney or liver disease
    • Elevated creatinine, urea, alanine transaminase (ALAT), aspartate transaminase (ASAT), bilirubin, basic phosphatases at blood test
  • Completion of pulmonary rehabilitation within the last 3 months

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: 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.
Experimental: Exercise
The HIIT intervention includes three supervised sessions per week over a 24-week period i.e., 72 exercise sessions and take place at CFAS or at home with supervision
Behavioral: High Intensity Interval Training (HIIT)

The HIIT intervention consist of 4 intervals with each lasting 4 minutes (4x4min). If a participant reports discomfort related to the length of the intervals or start to feel unmotivated by performing the same exercise, we will use another HIIT protocol: 10x1min.

The 4x4min HIIT consists of a warm-up period of 10 minutes with a target heart rate at 60-70% of HRmax, followed by 4 HIIT intervals with a target HR ≥85%. The intervals are separated by three minutes of active rest, in which the HR should drop to 60% of maximum. Following this, a cool down period of three minutes at warm up intensity is performed.

The 10x1min HIIT consists of a 10-minute warm-up period.The warm-up is followed by 10 intervals, each lasting 1 min at 100% of maximal workload, separated by three minutes of active rest, in which the HR should drop to 60% of maximum. Following the intervals, a cool down period of three minutes at warm up intensity is performed.
No Intervention: Control group
Controls will be encouraged to maintain current exercise habits for the duration of the study.

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
Pulmonary blood volume (mL) at rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in pulmonary blood volume (mL) at rest
6 months

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
DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest, 60% of current maximal workload (relative), and at follow-up including 60% of maximal workload at baseline (absolute)
6 months
Total LTM (g)
Time Frame: 6 months
Difference in change from baseline to six months between groups in total LTM (g)
6 months

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
DL,NO (mmol/(min kPa)) during exercise at 60% of current maximal workload (relative)
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during exercise at 60% of current maximal workload (relative)
6 months
DL,NO (mmol/(min kPa)) during exercise at 60% of the maximal workload measured at baseline (absolute)
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during exercise at 60% of the maximal workload measured at baseline (absolute)
6 months
Pulmonary blood volume / total blood volume ratio
Time Frame: 6 months
Difference in change from baseline to six months between groups in pulmonary blood volume / total blood volume ratio
6 months
Health-related quality of life - COPD Assessment Test (CAT) score
Time Frame: 6 months
Difference in change from baseline to six months between groups in health-related quality of life
6 months
Health-related quality of life - St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 6 months
Difference in change from baseline to six months between groups in health-related quality of life
6 months
Lobar LTM (g)
Time Frame: 6 months
Difference in change from baseline to six months between groups in lobar LTM (g)
6 months
LTM/1.73 m2 BSA (g/m2)
Time Frame: 6 months
Difference in change from baseline to six months between groups in LTM/1.73 m2 BSA (g/m2)
6 months
Total blood volume
Time Frame: 6 months
Difference in change from baseline to six months between groups in total blood volume
6 months
DL,NO (mmol/(min kPa)) during upright rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during upright rest
6 months
DL,CO,5s (mmol/(min kPa)) during upright rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,CO,5s (mmol/(min kPa)) during upright rest
6 months
Pulmonary capillary blood volume (VC, mL) during upright rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in pulmonary capillary blood volume (VC, mL) during upright rest
6 months
Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during upright rest
6 months
DL,NO (mmol/(min kPa)) during supine rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,NO (mmol/(min kPa)) during supine rest
6 months
DL,CO,5s (mmol/(min kPa)) during supine rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in DL,CO,5s (mmol/(min kPa)) during supine rest
6 months
Pulmonary capillary blood volume (VC, mL) during supine rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in pulmonary capillary blood volume (VC, mL) during supine rest
6 months
Alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest
Time Frame: 6 months
Difference in change from baseline to six months between groups in alveolar-capillary membrane diffusing capacity (DM, mmol/(min kPa)) during supine rest
6 months
Cardiac output (L/min) during exercise
Time Frame: 6 months
Difference in change from baseline to six months between groups in cardiac output (L/min) during exercise at 60% of current maximal workload and 60% of baseline maximal workload, in the supine position, and during upright rest
6 months
DL,CO,NO-based V̇O2 during exercise
Time Frame: 6 months
DL,CO,NO-based V̇O2 during exercise at 60% of current maximal workload and 60% of baseline maximal workload, in the supine position, and during upright rest
6 months
V̇O2peak
Time Frame: 6 months
Difference in change from baseline to six months between groups in relative (mL/kg/min) and absolute (mL/min) V̇O2peak, ventilatory threshold (%), and ventilatory reserve (%)
6 months
Time constant (s)
Time Frame: 6 months
Difference in change from baseline to six months between groups in time constant from V̇O2kinetic test
6 months
Amplitude (ml/kg^-1/min^-1)
Time Frame: 6 months
Difference in change from baseline to six months between groups in amplitude measured by V̇O2kinetic test
6 months
Time delay (s)
Time Frame: 6 months
Difference in change from baseline to six months between groups in time delay measured by V̇O2kinetic test
6 months
Hand-grip strength (kg)
Time Frame: 6 months
Difference in change from baseline to six months between groups in hand-grip strength (kg)
6 months
Sit-to-stand test (n)
Time Frame: 6 months
Difference in change from baseline to six months between groups in numbers of completed 30 seconds sit-to-stand test (n)
6 months
Body composition:
Time Frame: 6 months
Difference in change from baseline to six months between groups in body composition: total mass (kg), total fat mass (kg and %), lean body mass (kg), fat percentage (%)
6 months
Lung function
Time Frame: 6 months
Difference in change from baseline to six months between groups in lung function: FEV1 (L and %pred), FVC (L and %pred), RV (L and %pred), TLC (L and %pred), single-breath diffusion capacity to carbon monoxide (mmol/(min kPa) and %pred)
6 months
6-minute walking test
Time Frame: 6 months
Difference in change in the distance (m) walked from baseline to six months between groups in a 6-minute walking test
6 months
Blood samples
Time Frame: 6 months
Difference in change from baseline to six months between groups in exercise-induced cytokine responses (interleukin-6 (pg/mL), tumour necrosis factor-α (pg/mL), C-reactive protein (μg/mL), interleukin-8 (pg/mL), and interleukin-10 (pg/mL))
6 months
Mean bolus transit time (s) (supine rest)
Time Frame: 6 months
Difference in change from baseline to six months between groups in mean bolus transit time (s) (supine rest)
6 months
Mean bolus transit time (s) (adenosine infusion)
Time Frame: 6 months
Difference in change from baseline to six months between groups in mean bolus transit time (s) (adenosine infusion)
6 months
Global coronary flow reserve (mL/min)
Time Frame: 6 months
Difference in change from baseline to six months between groups in global coronary flow reserve (mL/min)
6 months
Pulmonary blood volume reserve (mL)
Time Frame: 6 months
Difference in change from baseline to six months between groups in pulmonary blood volume reserve (mL)
6 months
Left ventricular ejection fraction (%)
Time Frame: 6 months
Difference in change from baseline to six months between groups in left ventricular ejection fraction (%)
6 months
Cardiac output (L/min) (supine rest)
Time Frame: 6 months
Difference in change from baseline to six months between groups in cardiac output (L/min) (supine rest)
6 months
Cardiac output (L/min) (adenosine infusion)
Time Frame: 6 months
Difference in change from baseline to six months between groups in cardiac output (L/min) (adenosine infusion)
6 months
Total plasma volume
Time Frame: 6 months
Difference in change from baseline to six months between groups in total plasma volume
6 months
Red blood cells
Time Frame: 6 months
Difference in change from baseline to six months between groups in red blood cells
6 months
Coronary calcium score
Time Frame: 6 months
Difference in change from baseline to six months between groups in coronary calcium score
6 months
Intima-media thickness (IMT) in the common carotid artery (mm)
Time Frame: 6 months
Difference in change from baseline to six months between groups in intima-media thickness (IMT) in the common carotid artery (mm)
6 months
Blood samples
Time Frame: 6 months
Difference in change from baseline to six months between groups in blood samples: lipids (cholesterol (mmol/l), LDL (mmol/l), HDL (mmol/l)), HbA1C (mmol/l), HsCRP (mg/L), pro-BNP (pmol/L), and TSH (10-3 IU/L)
6 months
Resistance (Rrs, R5-R20)
Time Frame: 6 months
Difference in change from baseline to six months between groups in resistance (Rrs, R5-R20) measured by IOS
6 months
Reactance (Xrs, X5)
Time Frame: 6 months
Difference in change from baseline to six months between groups in reactance (Xrs, X5) measured by IOS
6 months

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.
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.
August 1, 2024

Primary Completion (Estimated)

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.
August 1, 2026

Study Completion (Estimated)

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.
August 1, 2026

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).
June 19, 2024

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.
August 12, 2024

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.
August 13, 2024

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.
August 13, 2024

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.
August 12, 2024

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.
August 1, 2024

More Information

Terms related to this study

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.
  • H-24021751

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings