Muscular Training-induced Changes in COPD

NCT03169270 | Completed

• 1 other identifier: Muscle-COPD
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Obstructive Pulmonary Disease; Healthy

Keywords

Exercise training; Muscle dysfunction; COPD

Outcome Measures

Primary Outcomes (2)

• Muscle oxygen saturation (StO2)

  Near-infrared spectroscopy (NIRS)

  Baseline - 8 weeks

• Skeletal muscle dysfunction

  Quadriceps muscle biopsies

  Baseline - 8 weeks

Secondary Outcomes (3)

• Maximal cardiopulmonary response to exercise training

  Baseline - 8 weeks

• Submaximal cardiopulmonary response to exercise training

  Baseline - 8 weeks

• Systemic effects of COPD

  Baseline - 8 weeks

Study Arms (2)

COPD training group

EXPERIMENTAL

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.

Other: Exercise training

Healthy training group

ACTIVE COMPARATOR

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.

Other: Exercise training

Interventions

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.

COPD training group; Healthy training group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Related Publications (1)

• 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.

  PMID: 29463285 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultor senior

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: November 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share