COPDCOPDEX-HIITNCT05273684
High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
A study testing High intensity interval training in people with COPD, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- 18-80 years
- Moderate to severe COPD(GOLD stage II to III)
Who cannot join
- Known ischaemic heart disease
- Known heart failure
- Previous or current coronavirus disease 2019 (COVID-19)
- Dementia or other severe neurological disease
- Known vascular
- Symptoms of disease within 2 weeks prior to the study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs. 10x1min in patients with moderate to severe COPD.
Read the detailed description
12 patients with severe to moderate COPD will be included in the study, where two different HIIT interventions will be compared with regards to fidelity and tolerability. Baseline measurements will be performed to assess fitness and cardiopulmonary health status for the included patients. The baseline measurements include a medical health interview and examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test, lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity), and an assessment of body composition. The following two visits consist of two different HIIT protocols.
Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at least a 3-day wash-out period.
- Conditions
- COPD
- Being tested
- High intensity interval training
- Keywords
- HIIT, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.
| Study group | Role | What they receive |
|---|---|---|
| 4*4 followed by 10*1 or 10*1 followed by 4*4 | Experimental | Following baseline measurements, participants are allocated to the random sequence, by which they will complete the two HIIT protocols ⟨http://www.randomization.com⟩ and based on this, patients are randomized to a specific testing sequence. Receives: Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise feasibility: Relative dose intensity (RDI) of exercise
RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100
Evaluated with a Red-Amber-Green system:
- Green: If ≥85% of the training is completed
- Amber: If 50-85% of the training is completed
- Red: If ≤ 50% of the training is completed
Measured: 1 week
Exercise feasibility: Exercise sessions requiring dose modifications
Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.
Measured: 1 week
Exercise tolerability: Subjective rating of the exercise session
Tolerability is measured with a 10-point Likert scale, where the participants evaluate the two HIIT protocols.
They will anser two quesitens:
- How tolerable was todays traning?
- How much did you enjoy todays training? Where 1 means not at all, and 10 means alot.
The Likert scale is scored as:
Red: 1-2 Amber: 3-4 Green: +5
Measured: 1 week
Exercise feasibility: Exercise sessions attendance rate
Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronan Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ronan Berg, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273684
- Sponsor's protocol ID
- CFAS_2021_1
- Acronym
- COPDEX-HIIT
- Status last verified
- Oct 2022
- First submitted
- 9 Nov 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nymand SB, Hartmann J, Rasmussen IE, Iepsen UW, Ried-Larsen M, Christensen RH, Berg RMG. Fidelity and tolerability of two high-intensity interval training protocols in patients with COPD: a randomised cross-over pilot study. BMJ Open Sport Exerc Med. 2023 Mar 8;9(1):e001486. doi: 10.1136/bmjsem-2022-001486. eCollection 2023.
PubMed 36919122
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
- ClinicalTrials.gov ID
- NCT05273684
- Acronym / sponsor ID
- COPDEX-HIIT / CFAS_2021_1
- Conditions
- COPD
- Keywords
- HIIT, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although high-intensity training (HIIT) is widely used in the rehabilitation of patients with chronic obstructive pulmonary disease (COPD), the optimal duration of intervals in terms of patient tolerability and fidelity is unknown.Thus, we will examine the fidelity and tolerability of the two most commonly used HIIT protocols, the classical so-called 4x4min vs. 10x1min in patients with moderate to severe COPD.
Detailed description
12 patients with severe to moderate COPD will be included in the study, where two different HIIT interventions will be compared with regards to fidelity and tolerability. Baseline measurements will be performed to assess fitness and cardiopulmonary health status for the included patients. The baseline measurements include a medical health interview and examination (blood pressure, heart rate, ECG), a maximal oxygen consumption (VO2max) test, lung function testing (dynamic spirometry, whole body plethysmography, diffusing capacity), and an assessment of body composition. The following two visits consist of two different HIIT protocols.
Each training session is evaluated by Borg Scale (5) and the Likert Scale (6), as well as time spent in with a heart rate above 85% of maximum. Each HIIT session is separated by at least a 3-day wash-out period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4*4 followed by 10*1 or 10*1 followed by 4*4 | Experimental | Other: High intensity interval trainingFollowing baseline measurements, participants are allocated to the random sequence, by which they will complete the two HIIT protocols ⟨http://www.randomization.com⟩ and based on this, patients are randomized to a specific testing sequence. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women
- 18-80 years
- Moderate to severe COPD(GOLD stage II to III)
Key exclusion criteria (7 listed)
- Known ischaemic heart disease
- Known heart failure
- Previous or current coronavirus disease 2019 (COVID-19)
- Dementia or other severe neurological disease
- Known vascular
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval trainingParticipants will undergo 4x4 and 1x10 minutes of interval training on two separate days. | Other | 4*4 followed by 10*1 or 10*1 followed by 4*4 |
Primary outcome
Exercise feasibility: Relative dose intensity (RDI) of exercise
Time frame: 1 week
RDI (%) of exercise, defined as prescribed exercise dose / performed exercise dose x 100 Evaluated with a Red-Amber-Green system: * Green: If ≥85% of the training is completed * Amber: If 50-85% of the training is completed * Red: If ≤ 50% of the training is completed
Exercise feasibility: Exercise sessions requiring dose modifications
Time frame: 1 week
Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.
Exercise tolerability: Subjective rating of the exercise session
Time frame: 1 week
Tolerability is measured with a 10-point Likert scale, where the participants evaluate the two HIIT protocols. They will anser two quesitens: 1. How tolerable was todays traning? 2. How much did you enjoy todays training? Where 1 means not at all, and 10 means alot. The Likert scale is scored as: Red: 1-2 Amber: 3-4 Green: +5
Exercise feasibility: Exercise sessions attendance rate
Time frame: 1 week
Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 36919122Nymand SB, Hartmann J, Rasmussen IE, Iepsen UW, Ried-Larsen M, Christensen RH, Berg RMG. Fidelity and tolerability of two high-intensity interval training protocols in patients with COPD: a randomised cross-over pilot study. BMJ Open Sport Exerc Med. 2023 Mar 8;9(1):e001486. doi: 10.1136/bmjsem-2022-001486. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronan Berg, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training in people with COPD, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise feasibility: Relative dose intensity (RDI) of exercise (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.