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High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study (COPDEX-HIIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05273684
Recruitment Status : Completed
First Posted : March 10, 2022
Last Update Posted : October 17, 2022
Information provided by (Responsible Party):
Ronan Berg, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE November 9, 2021
First Posted Date  ICMJE March 10, 2022
Last Update Posted Date October 17, 2022
Actual Study Start Date  ICMJE November 1, 2021
Actual Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
Official Title  ICMJE High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE COPD
Intervention  ICMJE Other: High intensity interval training
Participants will undergo 4x4 and 1x10 minutes of interval training on two separate days.
Study Arms  ICMJE 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.
Intervention: Other: High intensity interval training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2022)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2022
Actual Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05273684
Other Study ID Numbers  ICMJE CFAS_2021_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ronan Berg, Rigshospitalet, Denmark
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigshospitalet, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ronan Berg, MD Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP