We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Ronan Berg, Rigshospitalet, Denmark

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
COPD Other: High intensity interval training Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
Actual Study Start Date : November 1, 2021
Actual Primary Completion Date : July 1, 2022
Actual Study Completion Date : July 1, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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


  4. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273684


Locations
Layout table for location information
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Ronan Berg, MD Rigshospitalet, Denmark
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ronan Berg, MD, DMSc, Associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05273684    
Other Study ID Numbers: CFAS_2021_1
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ronan Berg, Rigshospitalet, Denmark:
HIIT
COPD