Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined respiratory physiotherapy and cardiovascular-strength training program.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Muscle Oxygenation, Exercise, Respiratory Physiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Behavioral Combined 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).
Primary outcome measures
- Change in muscle oxygen saturation (%) [Time frame: From baseline to end of intervention (4 weeks)]
Secondary outcome measures (7)
- Distance covered in 6-Minute Walk Test (6MWT) [Time frame: From baseline to after the 4-week intervention]
- Number of repetitions in the 30-Second Chair Stand Test [Time frame: From baseline to after the 4-week intervention]
- Perceived dyspnea and lower limb fatigue (Borg Scale) [Time frame: From baseline to after the 4-week intervention]
- Maximal inspiratory and expiratory pressures (Pimax and Pemax) [Time frame: From baseline to after the 4-week intervention]
- FEV1/FEV6 ratio (portable COPD Vitalograph) [Time frame: From baseline to after the 4-week intervention]
- Heart rate variability and max/min heart rate (Polar system + Kubios HRV) [Time frame: From baseline to after the 4-week intervention]
- Quality of life (COPD Assessment Test - CAT) [Time frame: From baseline to after the 4-week intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Portugal · 1 center
- Unidade Local de Saúde do Alto Alentejo (ULSAALE), Hospitals of Portalegre and Elvas, Port — Portalegre
Identifiers
NCT: NCT06968273 · 020525