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Muscular Training-induced Changes in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease, Healthy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Exercise training, Muscle dysfunction, COPD

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    COPD training group

    Healthy training group

    Arm Description

    COPD were required to be clinically stable at the time of study without episodes of exacerbation or oral steroid treatment in the previous four months. All COPD patients were on bronchodilators and inhaled corticosteroids. No patient presented severe co-morbidities. The intervention consists in an 8-week programe of exercise training.

    Healthy sedentary age-matched subjects were recruited from the outpatients' clinics of our hospital. The intervention consists in an 8-week programe of exercise training.

    Outcomes

    Primary Outcome Measures

    Muscle oxygen saturation (StO2)
    Near-infrared spectroscopy (NIRS)
    Skeletal muscle dysfunction
    Quadriceps muscle biopsies

    Secondary Outcome Measures

    Maximal cardiopulmonary response to exercise training
    Incremental exercise test
    Submaximal cardiopulmonary response to exercise training
    Constant work rate exercise test (CWRE)
    Systemic effects of COPD
    Blood sample

    Full Information

    First Posted
    May 23, 2017
    Last Updated
    May 25, 2017
    Sponsor
    Hospital Clinic of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03169270
    Brief Title
    Muscular Training-induced Changes in COPD
    Official Title
    Muscular Adaptations After Endurance Exercise Training in Patients With COPD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (Actual)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Clinic of Barcelona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease, Healthy
    Keywords
    Exercise training, Muscle dysfunction, COPD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD training group
    Arm Type
    Experimental
    Arm Description
    COPD were required to be clinically stable at the time of study without episodes of exacerbation or oral steroid treatment in the previous four months. All COPD patients were on bronchodilators and inhaled corticosteroids. No patient presented severe co-morbidities. The intervention consists in an 8-week programe of exercise training.
    Arm Title
    Healthy training group
    Arm Type
    Active Comparator
    Arm Description
    Healthy sedentary age-matched subjects were recruited from the outpatients' clinics of our hospital. The intervention consists in an 8-week programe of exercise training.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise training
    Intervention Description
    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 Outcome Measure Information:
    Title
    Muscle oxygen saturation (StO2)
    Description
    Near-infrared spectroscopy (NIRS)
    Time Frame
    Baseline - 8 weeks
    Title
    Skeletal muscle dysfunction
    Description
    Quadriceps muscle biopsies
    Time Frame
    Baseline - 8 weeks
    Secondary Outcome Measure Information:
    Title
    Maximal cardiopulmonary response to exercise training
    Description
    Incremental exercise test
    Time Frame
    Baseline - 8 weeks
    Title
    Submaximal cardiopulmonary response to exercise training
    Description
    Constant work rate exercise test (CWRE)
    Time Frame
    Baseline - 8 weeks
    Title
    Systemic effects of COPD
    Description
    Blood sample
    Time Frame
    Baseline - 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29463285
    Citation
    Tenyi A, Cano I, Marabita F, Kiani N, Kalko SG, Barreiro E, de Atauri P, Cascante M, Gomez-Cabrero D, Roca J. Network modules uncover mechanisms of skeletal muscle dysfunction in COPD patients. J Transl Med. 2018 Feb 20;16(1):34. doi: 10.1186/s12967-018-1405-y.
    Results Reference
    derived

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    Muscular Training-induced Changes in COPD

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