Clinical trial NCT06968273: Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD
Official title: Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD Undergoing a Cardiovascular and Strength Training Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Muscle Oxygenation
Exercise
Respiratory Physiotherapy
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in muscle oxygen saturation (%)
timeFrame: From baseline to end of intervention (4 weeks)
Secondary outcomes:
measure: Distance covered in 6-Minute Walk Test (6MWT)
timeFrame: From baseline to after the 4-week intervention
measure: Number of repetitions in the 30-Second Chair Stand Test
timeFrame: From baseline to after the 4-week intervention
measure: Perceived dyspnea and lower limb fatigue (Borg Scale)
timeFrame: From baseline to after the 4-week intervention
measure: Maximal inspiratory and expiratory pressures (Pimax and Pemax)
timeFrame: From baseline to after the 4-week intervention
measure: FEV1/FEV6 ratio (portable COPD Vitalograph)
timeFrame: From baseline to after the 4-week intervention
measure: Heart rate variability and max/min heart rate (Polar system + Kubios HRV)
timeFrame: From baseline to after the 4-week intervention
measure: Quality of life (COPD Assessment Test - CAT)
timeFrame: From baseline to after the 4-week intervention
Other outcomes:
Locations:
city: Portalegre
country: Portugal
facility: Unidade Local de Saúde do Alto Alentejo (ULSAALE), Hospitals of Portalegre and Elvas, Portugal
Study officials:
References: