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

• ClinicalTrials.gov Identifier: NCT05273684
• Recruitment Status: Completed
• First Posted: March 10, 2022
• Last Update Posted: October 17, 2022
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Ronan Berg, Rigshospitalet, Denmark

Tracking Information

• First Submitted Date: November 9, 2021
• First Posted Date: March 10, 2022
• Last Update Posted Date: October 17, 2022
• Actual Study Start Date: November 1, 2021
• Actual Primary Completion Date: July 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: High-intensity Interval Training in Patients With COPD: a Fidelity and Tolerability Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: COPD

Intervention

Other: High intensity interval training

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

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.

Intervention: Other: High intensity interval training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2022): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 1, 2022
• Actual Primary Completion Date: July 1, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT05273684
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Ronan Berg, Rigshospitalet, Denmark
• Original Responsible Party: Same as current
• Current Study Sponsor: Rigshospitalet, Denmark
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ronan Berg, MD; Rigshospitalet, Denmark

• PRS Account: Rigshospitalet, Denmark
• Verification Date: October 2022