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Not yet recruitingNCT06968273Updated May 13, 2025

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

An interventional study of Combined respiratory physiotherapy and cardiovascular-strength training program in Chronic Obstructive Pulmonary Disease (COPD), Muscle Oxygenation and Exercise, sponsored by University of Extremadura. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by University of Extremadura · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Muscle Oxygenation
  • Exercise
  • Respiratory Physiotherapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Decompensated heart failure or exercise-limiting comorbidities
  • Cognitive impairment or legal incapacity to consent
  • Inability to perform physical tasks
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Combined respiratory physiotherapy and cardiovascular-strength training program

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).

05

What researchers measure

Primary outcomes

  1. Change in muscle oxygen saturation (%)

    Measured in intercostal, quadriceps, and triceps surae muscles using NIRS (Moxy Monitor) during 6MWT and 30CST, before and after the 4-week intervention.

    Time frame: From baseline to end of intervention (4 weeks)

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

06

Study locations

1 site
  • Unidade Local de Saúde do Alto Alentejo (ULSAALE), Hospitals of Portalegre and Elvas, Portugal
    Portalegre, Portugal
    • Mª Dolores MD Apolo-Arenas, PhD · Contact · mdapolo@unex.es · 924489180
    • Mª Dolores Apolo Arenas, PhD · Principal investigator
07

Registry details

Key details

Study ID
NCT06968273
Lead sponsor
University of Extremadura
Responsible party
Alejandro Caña Pino (Investigator, University of Extremadura) — Principal investigator
First posted
May 13, 2025
Start date
May 2, 2025 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
May 13, 2025

Study contacts

Mª Dolores MD Apolo-Arenas, PhD
Contact
mdapolo@unex.es
924489180

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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