NCT07109687

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2025Jun 2027

First Submitted

Initial submission to the registry

July 16, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

July 16, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

High Intensity Interval TrainingExercise TrainingMuscle Oxygenation

Outcome Measures

Primary Outcomes (1)

  • 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.

    at the baseline, at the 4th week, at the end of the 8th week.

Secondary Outcomes (8)

  • Pulmonary Function test

    at the baseline, at the 4th week, at the end of the 8th week.

  • Functional Exercise Capacity

    at the baseline, at the 4th week, at the end of the 8th week.

  • Dyspnea

    at the baseline, at the 4th week, at the end of the 8th week.

  • Upper extremity Muscle Strength

    at the baseline, at the 4th week, at the end of the 8th week.

  • Activities of Daily Living

    at the baseline, at the 4th week, at the end of the 8th week.

  • +3 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

standard aerobic exercise will apply in moderate intensity continuous training.

Other: MICT

interval exercise group

EXPERIMENTAL
Other: HIIT GROUP

Interventions

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.

interval exercise group
MICTOTHER

Moderate intensity continous exercise

Control Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fulsen Bozkus, MD., Prof.

    Sağlık Bilimleri University Antalya Health Application and Research Center

    STUDY DIRECTOR
  • Aynur Demirel, PT, PhD, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aynur Demirel, PT, PhD, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Statistical Analyzer will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: HIIT or MICT will be applied in patients with COPD groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PT, PhD, Assoc. Prof.

Study Record Dates

First Submitted

July 16, 2025

First Posted

August 7, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 7, 2025

Record last verified: 2025-07