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

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD Undergoing a Cardiovascular and Strength Training Program

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06968273
Enrollment
15
Registered
2025-05-13
Start date
2025-05-02
Completion date
2025-10-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

This experimental pre-post study investigates the effects of a combined respiratory physiotherapy and physical training program on muscle oxygen saturation and functional capacity in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). COPD is a highly prevalent condition with a progressive impact on functional capacity, muscle performance, and quality of life. It is associated with systemic repercussions, including skeletal muscle dysfunction and oxygen transport limitations, which impair tolerance to physical activity. The study will evaluate the acute and cumulative effects of a structured, supervised intervention including respiratory physiotherapy techniques, cardiovascular training, and progressive resistance training. Measurements will be taken before and after the intervention period to assess changes in muscle oxygen saturation-measured using near-infrared spectroscopy (NIRS) devices (Moxy Monitor)-in key muscle groups (intercostal, quadriceps, and triceps surae). Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) and the 30-Second Chair Stand Test (30CST). Additional variables including inspiratory and expiratory pressures, pulmonary function (FEV1/FEV6), heart rate variability, dyspnea, lower limb fatigue, and quality of life (COPD Assessment Test) will also be recorded. The intervention consists of 20 hospital-based sessions over four weeks (five sessions per week). The protocol is designed to reflect real clinical settings and aims to provide evidence for the feasibility, safety, and functional relevance of combining respiratory and musculoskeletal rehabilitation strategies in COPD patients.

Interventions

BEHAVIORALCombined respiratory physiotherapy and cardiovascular-strength training program

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).

Sponsors

University of Extremadura
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle oxygen saturation (%)From baseline to end of intervention (4 weeks)Measured in intercostal, quadriceps, and triceps surae muscles using NIRS (Moxy Monitor) during 6MWT and 30CST, before and after the 4-week intervention.

Secondary

MeasureTime frame
Number of repetitions in the 30-Second Chair Stand TestFrom 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
Distance covered in 6-Minute Walk Test (6MWT)From baseline to after the 4-week intervention
Heart rate variability and max/min heart rate (Polar system + Kubios HRV)From baseline to after the 4-week intervention
Quality of life (COPD Assessment Test - CAT)From baseline to after the 4-week intervention
FEV1/FEV6 ratio (portable COPD Vitalograph)From baseline to after the 4-week intervention

Countries

Portugal

Contacts

Primary ContactMª Dolores MD Apolo-Arenas, PhD
mdapolo@unex.es924489180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026