NCT07285642

Brief Summary

This interventional study aims to investigate the acute effects of different types of exercise on cerebral and peripheral muscle oxygenation in patients with chronic obstructive pulmonary disease (COPD). Functional near-infrared spectroscopy (fNIRS) and near-infrared spectroscopy (NIRS) will be used simultaneously to measure oxygenation changes in the prefrontal cortex and the vastus lateralis muscle during rest, Stroop task performance, the six-minute walk test, aerobic, strengthening, and breathing exercises. The study will compare COPD patients and age- and sex-matched healthy controls to determine how brain and muscle oxygenation responses differ between groups and among exercise modalities. The findings are expected to guide the design of safe, individualized pulmonary rehabilitation programs that optimize oxygenation without compromising safety.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Apr 2025Nov 2026

Study Start

First participant enrolled

April 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

November 20, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

COPDFNIRSBrainQuadriceps femoris

Outcome Measures

Primary Outcomes (1)

  • Change in cerebral oxygenation during exercise

    fNIRS device (Artinis Brite Lite, The Netherlands) with 8-channel prefrontal montage, sampling at 10 Hz. Data analyzed with MATLAB-based Homer3 and NIRS-KIT software.

    Day 1

Secondary Outcomes (5)

  • Change in peripheral muscle oxygenation

    Day 1

  • Cognitive performance (reaction time, accuracy in Stroop task)

    Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).

  • Six-Minute Walk Distance (6MWD)

    Baseline

  • Perceived Dyspnea (Modified Borg Scale)

    Day 1

  • Physical Activity Level (IPAQ-Short Form)

    Baseline

Study Arms (2)

COPD

EXPERIMENTAL
Other: Aerobic Exercise (Treadmill Walking)Other: Resistance Exercise (Upper and Lower Limb Strength Training)Other: Breathing ExercisesOther: Cognitive Task (Stroop Task)

Healthy Individuals

EXPERIMENTAL
Other: Aerobic Exercise (Treadmill Walking)Other: Resistance Exercise (Upper and Lower Limb Strength Training)Other: Breathing ExercisesOther: Cognitive Task (Stroop Task)

Interventions

Participants perform controlled breathing exercises including diaphragmatic, chest, and lateral basal breathing techniques. Each pattern is executed in 10-repetition cycles, repeated for 15 minutes with 10-second rest intervals. All sessions begin with pursed-lip breathing instruction and are performed in a seated position.

COPDHealthy Individuals

A computerized color-word interference test (PsychoPy software) is administered before and after the exercise session to evaluate executive function and attention. Performance is analyzed in relation to concurrent fNIRS measurements from the prefrontal cortex.

COPDHealthy Individuals

Participants perform resistance exercises for upper and lower limb major muscle groups using 60% of one-repetition maximum (1RM). Each exercise consists of 12 repetitions per set, repeated for 15 minutes with 10-second rest intervals between sets. Movements include shoulder flexion/abduction/extension, hip flexion/abduction/adduction/extension, knee extension, and squatting.

COPDHealthy Individuals

Participants perform treadmill walking for 15 minutes at 60% of the heart rate reserve (HRR), following a 2-minute warm-up period. Exercise intensity is calculated individually using the Karvonen formula. Continuous oxygenation monitoring is conducted via fNIRS (prefrontal cortex) and NIRS (vastus lateralis).

COPDHealthy Individuals

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70 years
  • Diagnosis of moderate-to-severe COPD (GOLD stage II-III)
  • Stable disease (no exacerbation in previous 4 weeks)
  • BMI 18.5-24.9 kg/m²
  • Manual muscle strength ≥ 4 (MRC scale)
  • Ability to perform exercise tests safely
  • Written informed consent

You may not qualify if:

  • Severe comorbid conditions (uncontrolled cardiac, neurological, or orthopedic disease)
  • Need for high-flow oxygen therapy (\>2 L/min)
  • History of cerebrovascular disease or transient ischemic attack
  • Musculoskeletal or dermatological conditions impairing NIRS measurement sites
  • Restrictive lung disease, interstitial lung disease, or small-airway disease
  • Participation in an exercise program within the last 12 months
  • Healthy Controls
  • Age 40-70 years
  • No acute or chronic disease
  • Non-smoker
  • BMI 18.5-24.9 kg/m²
  • No musculoskeletal limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Pehlivan

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

ExerciseBreathing ExercisesStroop Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesNeuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 16, 2025

Study Start

April 30, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations