Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD Undergoing a Cardiovascular and Strength Training Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in muscle oxygen saturation (%)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention Group
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.
Intervention: Combined respiratory physiotherapy and cardiovascular-strength training program (Behavioral)
Outcomes
Primary Outcomes
Change in muscle oxygen saturation (%)
Time Frame: 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 Outcomes
- Perceived dyspnea and lower limb fatigue (Borg Scale)(From baseline to after the 4-week intervention)
- FEV1/FEV6 ratio (portable COPD Vitalograph)(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)
- 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)
- Maximal inspiratory and expiratory pressures (Pimax and Pemax)(From baseline to after the 4-week intervention)
Investigators
Alejandro Caña Pino
Investigator
University of Extremadura