Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD

NCT06968273 | Not Yet Recruiting

• 1 other identifier: 020525
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental pre-post intervention study aims to evaluate the effect of a respiratory physiotherapy and combined strength and cardiovascular training program on muscle oxygen saturation and functional capacity in patients with Chronic Obstructive Pulmonary Disease (COPD). Oxygenation of the intercostal, quadriceps, and triceps surae muscles will be assessed using near-infrared spectroscopy (NIRS) during standard physical performance tests (6-Minute Walk Test and 30-Second Chair Stand Test). Additional functional parameters and quality of life will be recorded pre- and post-intervention. The results will contribute to optimizing rehabilitation programs and monitoring intensity and progress through muscle oxygenation data.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Muscle Oxygenation; Exercise; Respiratory Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Change in muscle oxygen saturation (%)

  Measured in intercostal, quadriceps, and triceps surae muscles using NIRS (Moxy Monitor) during 6MWT and 30CST, before and after the 4-week intervention.

  From baseline to end of intervention (4 weeks)

Secondary Outcomes (7)

• Distance covered in 6-Minute Walk Test (6MWT)

  From baseline to after the 4-week intervention

• Number of repetitions in the 30-Second Chair Stand Test

  From baseline to after the 4-week intervention

• Perceived dyspnea and lower limb fatigue (Borg Scale)

  From baseline to after the 4-week intervention

• Maximal inspiratory and expiratory pressures (Pimax and Pemax)

  From baseline to after the 4-week intervention

• FEV1/FEV6 ratio (portable COPD Vitalograph)

  From baseline to after the 4-week intervention

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants will undergo a 4-week combined respiratory physiotherapy and strength-cardio training program, supervised in hospital. Muscle oxygen saturation and functional variables will be measured pre- and post-intervention.

Behavioral: Combined respiratory physiotherapy and cardiovascular-strength training program

Interventions

Combined respiratory physiotherapy and cardiovascular-strength training program BEHAVIORAL

20-session supervised hospital-based program including respiratory physiotherapy, aerobic training (guided by Borg scale and HR monitoring), and strength training using progressive loads (based on 1RM). Duration: 4 weeks (5 sessions/week).

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Clinical diagnosis of COPD
• Medically cleared for physical exercise

You may not qualify if:

• Decompensated heart failure or exercise-limiting comorbidities
• Cognitive impairment or legal incapacity to consent
• Inability to perform physical tasks

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Unidade Local de Saúde do Alto Alentejo (ULSAALE), Hospitals of Portalegre and Elvas, Portugal

Portalegre, Portugal

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mª Dolores MD Apolo-Arenas, PhD

CONTACT

924489180; mdapolo@unex.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 2, 2025
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

PT (1)