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CompletedNCT05273684COPDEX-HIITUpdated Oct 17, 2022

High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study

An interventional study of High intensity interval training in COPD, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-17.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • COPD

Keywords

  • HIIT
  • COPD
03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 35 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women
  • 18-80 years
  • Moderate to severe COPD(GOLD stage II to III)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    4*4 followed by 10*1 or 10*1 followed by 4*4

    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.

    Other: High intensity interval training

Interventions

  • OtherHigh intensity interval training

    Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 week

  2. Exercise feasibility: Exercise sessions requiring dose modifications

    Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.

    Time frame: 1 week

  3. 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: 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

    Time frame: 1 week

  4. Exercise feasibility: Exercise sessions attendance rate

    Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100

    Time frame: 1 week

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05273684
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Ronan Berg (MD, DMSc, Associate professor, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Mar 10, 2022
Start date
Nov 1, 2021
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022
Last update
Oct 17, 2022

Study contacts

Ronan Berg, MD
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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