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NCT Number: NCT06968273

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Portalegre, Portugal

Location contact

Mª Dolores Apolo Arenas, PhD

PRINCIPAL_INVESTIGATOR

Mª Dolores MD Apolo-Arenas, PhD

CONTACT

[email protected]

924489180

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Distance covered in 6-Minute Walk Test (6MWT)

    Time frame: From baseline to after the 4-week intervention

  2. Number of repetitions in the 30-Second Chair Stand Test

    Time frame: From baseline to after the 4-week intervention

  3. Perceived dyspnea and lower limb fatigue (Borg Scale)

    Time frame: From baseline to after the 4-week intervention

  4. Maximal inspiratory and expiratory pressures (Pimax and Pemax)

    Time frame: From baseline to after the 4-week intervention

  5. FEV1/FEV6 ratio (portable COPD Vitalograph)

    Time frame: From baseline to after the 4-week intervention

  6. Heart rate variability and max/min heart rate (Polar system + Kubios HRV)

    Time frame: From baseline to after the 4-week intervention

  7. Quality of life (COPD Assessment Test - CAT)

    Time frame: From baseline to after the 4-week intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Mª Dolores MD Apolo-Arenas, PhD

CONTACT

[email protected]

924489180

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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