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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: High intensity interval training

• Registration Number: NCT05273684
• Lead Sponsor: Rigshospitalet, Denmark

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-10
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4*4 followed by 10*1 or 10*1 followed by 4*4	High intensity interval training	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.

Primary Outcome Measures

Name	Time	Method
Exercise tolerability: Subjective rating of the exercise session	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: Relative dose intensity (RDI) of exercise	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 attendance rate	1 week	Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
Exercise feasibility: Exercise sessions requiring dose modifications	1 week	Incidence of exercise sessions requiring dose modifications, defined as any deviation from the prescribed exercise.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark