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

NCT05273684 | Completed

• 1 other identifier: CFAS_2021_1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

HIIT; COPD

Outcome Measures

Primary Outcomes (4)

• 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: 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

  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

Study Arms (1)

4*4 followed by 10*1 or 10*1 followed by 4*4

EXPERIMENTAL

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

Interventions

High intensity interval training OTHER

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

4*4 followed by 10*1 or 10*1 followed by 4*4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Nymand SB, Hartmann J, Rasmussen IE, Iepsen UW, Ried-Larsen M, Christensen RH, Berg RMG. Fidelity and tolerability of two high-intensity interval training protocols in patients with COPD: a randomised cross-over pilot study. BMJ Open Sport Exerc Med. 2023 Mar 8;9(1):e001486. doi: 10.1136/bmjsem-2022-001486. eCollection 2023.

  PMID: 36919122 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ronan Berg, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Associate professor

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: March 10, 2022
• Study Start: November 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)