Chronic Obstructive Pulmonary Disease (COPD)NCT07109687
HIIT Versus MICT in COPD: Effects on Oxygenation, Pulmonary Function, and Strength
A study testing HIIT GROUP and MICT in people with Chronic Obstructive Pulmonary Disease (COPD), run by Aynur Demirel.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive condition marked by airflow limitation and chronic inflammation, leading to reduced exercise capacity, peripheral muscle dysfunction, and dyspnea. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- HIIT GROUP and MICT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Chronic Obstructive Pulmonary Disease (COPD),
- GOLD stage 2, 3, or 4,
- Willing to participate in the study,
- Aged between 40 and 80 years,
- Clinically stable (no significant deterioration in the current medical condition, no recent initiation of a new treatment, and no complications requiring hospitalization).
Who cannot join
- Presence of visual, auditory, vestibular, cognitive, or neurological impairments that may affect balance,
- Any orthopedic, neurological, or cardiac conditions that may interfere with study participation or exercise,
- Presence of serious chronic diseases such as congestive heart failure, coronary artery disease, or chronic renal failure,
- Conditions that may cause physical limitations (e.g., limb amputation, significant musculoskeletal disorders, or postural abnormalities such as kyphosis or lordosis).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Peripheral and Respiratory Muscle Oxygenation, Pulmonary Function, Exercise Capacity, and Peripheral Muscle Strength in Individuals With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD) is a progressive condition marked by airflow limitation and chronic inflammation, leading to reduced exercise capacity, peripheral muscle dysfunction, and dyspnea. High-Intensity Interval Training (HIIT) may offer a promising alternative for patients with low exercise tolerance; however, evidence on its effectiveness remains limited.
This study aims to compare the effects of HIIT and Moderate-Intensity Continuous Training (MICT) on muscle oxygenation, pulmonary function, exercise capacity, and peripheral muscle strength in individuals with COPD. Participants will undergo an 8-week exercise program, twice weekly. HIIT will consist of 1-minute intervals at 90% and 30-40% of peak workload, while MICT will involve continuous cycling at 65% of peak workload. Outcomes will be assessed at baseline, week 4, and week 8. Data will be analyzed using SPSS. This study seeks to determine the more effective training modality to optimize COPD rehabilitation.
- Being tested
- HIIT GROUP, MICT
- Keywords
- High Intensity Interval Training, Exercise Training, Muscle Oxygenation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT GROUPOther
Participants will perform a 31-minute protocol on a cycle ergometer consisting of 1-minute high-intensity intervals at 90% of peak workload (W peak) and low-intensity intervals at 30-40% of W peak, twice a week for 8 weeks.
MICTOther
Moderate intensity continous exercise
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | standard aerobic exercise will apply in moderate intensity continuous training. Receives: Other: MICT |
| interval exercise group | Experimental | Not described Receives: Other: HIIT GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral and Respiratory Muscle Oxygenation
Muscle oxygenation will be measured using Near-Infrared Spectroscopy from the dominant quadriceps (peripheral) and 7th intercostal space (respiratory) during rest, warm-up, exercise, recovery phases, and 5 minutes post-exercise. Parameters include SmO₂_basal, SmO₂_max, SmO₂_min, SmO₂_maxrec, ∆SmO₂_max, SmO₂_deox, SmO₂_reoxy, and ∆SmO₂_maxrec.
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Secondary outcomes (8)
Pulmonary Function test
Pulmonary function will be evaluated using spirometry in accordance with ATS/ERS guidelines. the outcomes presented as liter/minute.
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Functional Exercise Capacity
Functional exercise capacity will be assessed using the 6-Minute Walk Test (6MWT) according to ATS guidelines.
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Dyspnea
Dyspnea will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale, a 5-point ordinal scale evaluating activity-induced breathlessness.
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Upper extremity Muscle Strength
Upper extremity will measure by hand dynomometer. The highest grip force will be recorded as kilograms.
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Activities of Daily Living
Activity limitation due to dyspnea will be assessed by the London Chest Activity of Daily Living Scale (LCADL). Total and subscale scores will be analyzed (range: 0-75).
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Health-Related Quality of Life
Quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ). Total and subscale scores (Symptoms, Activity, Impacts) will be recorded (range: 0-100).
Measured: at the baseline, at the 4th week, at the end of the 8th week.
Comorbidities
Comorbidity burden will be assessed using the Charlson Comorbidity Index (CCI)
Measured: at the baseline, at the 4th week, at the end of the 8th week.
lower extremity endurance test
30 second chair stand test will use. The number of repetitions will be recorded.
Measured: at baseline, at the 4th week and at the end of 8th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HIIT or MICT will be applied in patients with COPD groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aynur Demirel
- Sponsor type
- University, hospital or other
- Collaborators
- Antalya Bilim University, Hacettepe University
- Responsible party
- Sponsor-investigator, Aynur Demirel, Hacettepe University
- Investigators
- Fulsen Bozkus, MD., Prof., Study director, Sağlık Bilimleri University Antalya Health Application and Research CenterAynur Demirel, PT, PhD, Assoc. Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109687
- Sponsor's protocol ID
- BSV-000021
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Peripheral and Respiratory Muscle Oxygenation, Pulmonary Function, Exercise Capacity, and Peripheral Muscle Strength in Individuals With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07109687
- Acronym / sponsor ID
- BSV-000021
- Keywords
- High Intensity Interval Training, Exercise Training, Muscle Oxygenation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aynur DemirelUniversity, hospital or other
- Collaborators
- Antalya Bilim University, Hacettepe University
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) is a progressive condition marked by airflow limitation and chronic inflammation, leading to reduced exercise capacity, peripheral muscle dysfunction, and dyspnea. High-Intensity Interval Training (HIIT) may offer a promising alternative for patients with low exercise tolerance; however, evidence on its effectiveness remains limited.
This study aims to compare the effects of HIIT and Moderate-Intensity Continuous Training (MICT) on muscle oxygenation, pulmonary function, exercise capacity, and peripheral muscle strength in individuals with COPD. Participants will undergo an 8-week exercise program, twice weekly. HIIT will consist of 1-minute intervals at 90% and 30-40% of peak workload, while MICT will involve continuous cycling at 65% of peak workload. Outcomes will be assessed at baseline, week 4, and week 8. Data will be analyzed using SPSS. This study seeks to determine the more effective training modality to optimize COPD rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- HIIT or MICT will be applied in patients with COPD groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: MICTstandard aerobic exercise will apply in moderate intensity continuous training. |
| interval exercise group | Experimental | Other: HIIT GROUP |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Chronic Obstructive Pulmonary Disease (COPD),
- GOLD stage 2, 3, or 4,
- Willing to participate in the study,
- Aged between 40 and 80 years,
- Clinically stable (no significant deterioration in the current medical condition, no recent initiation of a new treatment, and no complications requiring hospitalization).
Key exclusion criteria (4 listed)
- Presence of visual, auditory, vestibular, cognitive, or neurological impairments that may affect balance,
- Any orthopedic, neurological, or cardiac conditions that may interfere with study participation or exercise,
- Presence of serious chronic diseases such as congestive heart failure, coronary artery disease, or chronic renal failure,
- Conditions that may cause physical limitations (e.g., limb amputation, significant musculoskeletal disorders, or postural abnormalities such as kyphosis or lordosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT GROUPParticipants will perform a 31-minute protocol on a cycle ergometer consisting of 1-minute high-intensity intervals at 90% of peak workload (W peak) and low-intensity intervals at 30-40% of W peak, twice a week for 8 weeks. | Other | interval exercise group |
| MICTModerate intensity continous exercise | Other | Control Group |
Primary outcome
Peripheral and Respiratory Muscle Oxygenation
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Muscle oxygenation will be measured using Near-Infrared Spectroscopy from the dominant quadriceps (peripheral) and 7th intercostal space (respiratory) during rest, warm-up, exercise, recovery phases, and 5 minutes post-exercise. Parameters include SmO₂_basal, SmO₂_max, SmO₂_min, SmO₂_maxrec, ∆SmO₂_max, SmO₂_deox, SmO₂_reoxy, and ∆SmO₂_maxrec.
8 secondary outcomes
Pulmonary Function test
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Functional Exercise Capacity
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Dyspnea
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Upper extremity Muscle Strength
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Activities of Daily Living
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Health-Related Quality of Life
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
Comorbidities
Time frame: at the baseline, at the 4th week, at the end of the 8th week.
lower extremity endurance test
Time frame: at baseline, at the 4th week and at the end of 8th week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fulsen Bozkus, MD., Prof. study director
Sağlık Bilimleri University Antalya Health Application and Research Center
Aynur Demirel, PT, PhD, Assoc. Prof. principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing HIIT GROUP and MICT in people with Chronic Obstructive Pulmonary Disease (COPD), run by Aynur Demirel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aynur Demirel, PT, PhD, Assoc. Prof. (+903051576168, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral and Respiratory Muscle Oxygenation (time frame: at the baseline, at the 4th week, at the end of the 8th week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.