High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease (Effects of Hig)

November 2, 2026 updated by: Fu Jen Catholic University Hospital

Effects of High-Intensity Interval Alternating Concentric-Eccentric Training on Functional Performance in Patients With Chronic Respiratory Disease: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effects of high-intensity interval training incorporating alternating concentric and eccentric cycling on functional performance in adults with chronic respiratory disease undergoing pulmonary rehabilitation. A total of 45 participants will be randomly assigned to one of three groups: high-intensity interval alternating concentric-eccentric training, high-intensity interval concentric training, or usual care. Participants in the exercise training groups will complete a 12-week supervised exercise program, while the usual-care group will continue routine care with self-regulated exercise intensity. Functional performance, exercise capacity, and patient-reported outcomes will be assessed before and after the intervention. The study seeks to determine whether incorporating eccentric exercise into high-intensity interval training can improve physical function while reducing cardiopulmonary and perceived exercise burden.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic respiratory diseases, particularly chronic obstructive pulmonary disease (COPD), are commonly associated with exercise intolerance, dyspnea, peripheral muscle dysfunction, and reduced quality of life. Although exercise training is a central component of pulmonary rehabilitation, patients may have difficulty tolerating conventional high-intensity exercise because of ventilatory limitation and leg fatigue.

Eccentric exercise can generate relatively high mechanical workloads with lower oxygen consumption and cardiopulmonary demand than concentric exercise. High-intensity interval training (HIIT), on the other hand, is an effective approach for improving aerobic capacity. This study therefore investigates whether incorporating eccentric cycling into the recovery periods of HIIT can provide additional skeletal muscle stimulation without substantially increasing cardiopulmonary stress.

This is a single-center, prospective, randomized controlled trial conducted at Fu Jen Catholic University Hospital. Forty-five adults with chronic respiratory disease who have participated in pulmonary rehabilitation for more than 3 months will be enrolled and randomly allocated to three groups, with approximately 15 participants in each group: (1) high-intensity interval alternating concentric-eccentric training, (2) high-intensity interval concentric training, or (3) usual care.

Before randomization, participants will undergo graded exercise testing, functional performance assessments, and questionnaires. Participants assigned to the exercise groups will complete supervised training for 12 weeks. The alternating concentric-eccentric group will also undergo an eccentric exercise familiarization period before the formal training program. Participants in the usual-care group will continue routine care with self-regulated exercise intensity for 12 weeks. After the intervention, graded exercise testing, functional assessments, and questionnaires will be repeated.

The study will evaluate changes in functional performance, exercise capacity, muscle function, symptoms, and quality of life to determine whether alternating concentric-eccentric HIIT provides additional benefits compared with conventional concentric HIIT and usual care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • New Taipei City
      • New Taipei City, New Taipei City, Taiwan, 24352
        • Fu Jen Catholic University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able and willing to provide written informed consent. Adults aged 18 years or older with chronic respiratory disease. Have participated in a pulmonary rehabilitation program for more than 3 months. For participants with an implanted cardioverter-defibrillator (ICD), the programmed maximum heart rate must be higher than the target heart rate used during exercise training.

Considered medically suitable for exercise training by a specialist physician.

Exclusion Criteria:

  • Presence of a tracheostomy. Use of long-term home oxygen therapy or home mechanical ventilation. Severe left-sided heart failure classified as New York Heart Association (NYHA) functional class III or IV.

Diagnosis of a neuromuscular disease. Acute exacerbation of chronic obstructive pulmonary disease (COPD) within the previous 3 months.

Unable to complete or cooperate with cardiopulmonary exercise testing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alternating Concentric-Eccentric HIIT

Participants will undergo a 2-week eccentric cycling familiarization period followed by 12 weeks of high-intensity interval training. During the high-intensity intervals, concentric cycling will be performed at 80% of peak work rate, while the recovery intervals will use eccentric cycling at the same external workload.
Behavioral: Alternating Concentric-Eccentric High-Intensity Interval Training

Participants will complete a 2-week eccentric cycling familiarization period followed by 12 weeks of supervised high-intensity interval training, performed twice weekly. Each formal training session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of eccentric cycling performed at the same external workload as the high-intensity concentric interval.

Other Names:
  • Alternating Concentric-Eccentric HIIT
Active Comparator: Concentric HIIT

Participants will undergo 12 weeks of high-intensity interval concentric cycling training. High-intensity intervals will be performed at 80% of peak work rate, with recovery intervals performed concentrically at 40% of peak work rate.
Behavioral: Concentric High-Intensity Interval Training

Participants will complete 12 weeks of supervised high-intensity interval concentric cycling training, performed twice weekly. Each session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of concentric cycling at 40% Wpeak.

Other Names:
  • Concentric HIIT
Active Comparator: Usual Care

Participants will continue usual care with self-regulated exercise intensity for 12 weeks.
Behavioral: Usual Care

Participants will continue usual care with self-regulated exercise intensity for 12 weeks. No structured high-intensity interval or eccentric cycling training will be provided as part of the study intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 6-Minute Walk Distance
Time Frame: Baseline and 12 weeks

The 6-minute walk test will be used to assess functional exercise capacity. The distance walked in 6 minutes on a 30-meter indoor corridor will be recorded in meters. Change from baseline to post-intervention will be compared among the three study groups.
Baseline and 12 weeks
Change in Timed Up and Go Test
Time Frame: Baseline and 12 weeks

The Timed Up and Go test will be used to assess functional mobility, balance, and gait performance. Participants will stand from a chair, walk 3 meters, turn, return to the chair, and sit down. Three trials will be performed, and the fastest completion time in seconds will be used for analysis.
Baseline and 12 weeks
Change in Stair Climbing Performance
Time Frame: Baseline and 12 weeks

Stair climbing performance will be assessed using a fixed number of stairs to evaluate lower-extremity strength, balance, agility, and functional performance. Completion time will be recorded in seconds.
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in St. George's Respiratory Questionnaire Score
Time Frame: Baseline and after 12 weeks of formal training

Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). Changes in total score from baseline to post-intervention will be evaluated.
Baseline and after 12 weeks of formal training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fu Jen Catholic University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hui-Wen Hsu, M.S., Fu Jen Catholic University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FJUH115600

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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