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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: High intensity interval training

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
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week
Exercise feasibility: Exercise sessions requiring dose modifications	Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.	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	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	1 week

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Ronan Berg, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COPD; HIIT
• Other Study ID Numbers: CFAS_2021_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No