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Completed

NCT Number: NCT03169270

Muscular Training-induced Changes in COPD

The current protocol is developed in the context of a large Research and Innovation (R&I) program aiming the promotion of daily life physical activity in chronic patients registered at clinicaltrials.gov (NCT02976064) and approved by the ethical committee of the Hospital Clinic de Barcelona (HCB/2016/0883). The project is partly supported by the Smart Innovation Strategies promoted by the EU Commission (COMRDI15-1-0016). Specifically, the protocol uses retrospective information collected between 2005-2008 as part of the EU project Biobridge (LSHG-CT-2006-037939).

The aims of the current analysis of the retrospective information are 1) to assess training-induced changes in muscle oxygen saturation (StO2) assessed by near-infrared spectroscopy (NIRS) during constant-work rate cycling exercise (CWRE) as a useful marker of the effects of training at limb muscle level in patients with chronic obstructive pulmonary disease (COPD), and 2) to further explore underlying mechanisms of skeletal muscle dysfunction as a characteristic systemic effect of COPD, potentially modifiable with preventive interventions as endurance muscle training.

Methods: Incremental exercise (VO2 peak) and CWRE at 70% baseline peak work rate, before and after 8-week of endurance exercise training, were done in healthy sedentary subjects and COPD patients. NIRS was used to assess StO2 in the left "vastus internus" during the CWRE (before an after training program) (objective 1); and blood samples and muscle biopsies of the quadriceps were obtained at rest (before an after training program) (objective 2).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Healthy Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • COPD diagnosis following GOLD criteria (FEV1/FVC post-broncodilator <0,7)
  • Clinical stability for at least 3 months

Exclusion criteria

  • Age <45 years
  • Any active cancer
  • Comorbidities which carry high-level of handicap
  • Other respiratory disease than COPD
  • No sign of informed consent

Treatment and study plan

Exercise training

Other

All subjects performed a supervised 8-week, 5 days-week of endurance exercise training program in cycle-ergometer Each session included 5 minutes of warm-up and cool-down pedalling at 30% of peak work-rate (WR) and 50 minutes of interval training. The interval training combined 2 minutes of high-intensity pedalling and 3 minutes of active rest. Work-rate progress during the 8-week period was tailored on individual basis, according to subjects' symptoms, to maximize the training effect. During the first 2 weeks, high intensity pedalling interval was at least 70% of peak WR and active rest interval was at least 40% of peak WR. Thereafter, work-rate was increased by approximately 5% every week up to a maximum of 100% of peak WR during the last 2 weeks for the high intensity period and 50% of peak WR for the active rest. The cycling rate during the sessions was maintained at 60-70 rpm.

Primary outcomes

  1. Muscle oxygen saturation (StO2)

    Time frame: Baseline - 8 weeks

    Near-infrared spectroscopy (NIRS)

  2. Skeletal muscle dysfunction

    Time frame: Baseline - 8 weeks

    Quadriceps muscle biopsies

Secondary outcomes

  1. Maximal cardiopulmonary response to exercise training

    Time frame: Baseline - 8 weeks

    Incremental exercise test

  2. Submaximal cardiopulmonary response to exercise training

    Time frame: Baseline - 8 weeks

    Constant work rate exercise test (CWRE)

  3. Systemic effects of COPD

    Time frame: Baseline - 8 weeks

    Blood sample

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Muscular Adaptations After Endurance Exercise Training in Patients With COPD

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 30, 2017
Registry last updated
May 30, 2017

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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