Eccentric Training in Individuals With COPD

NCT04785469 | Completed

• 1 other identifier: Eccentric Training_COPD_FDG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Skeletal muscle dysfunction as a systemic consequence of chronic obstructive pulmonary disease (COPD) has a major impact on quality of life, health care resource utilization, and mortality of patients with this disease. In fact, a vicious circle of inactivity and disuse is established in the advanced stages of the disease, inducing a progressive decline in exercise tolerance and a loss of muscle mass (especially in locomotor muscles), resulting in the inability of patients to perform even the simplest daily activities. In this context, the multidisciplinary rehabilitation approach includes not only recovery of exercise capacity but also training aimed at restoring muscle function in patients with COPD. However, there is considerable methodological variability among muscle resistance training programs used in clinical practice with patients with COPD. This is compounded by the need to identify alternative training strategies effective in inducing functional adaptation in skeletal muscle without increasing the degree of dyspnea or fatigue in those symptomatic patients with advanced stages of disease. Among these, eccentric exercise or negative work, i.e. the stretching of the muscle during the active contraction phase, represents a valid alternative to traditional concentric training in various rehabilitation contexts. The main advantages of this training method are: 1) eccentric contraction is able to produce greater forces than isometric and concentric contraction; 2) for the same resistance, eccentric contraction has a lower metabolic cost than concentric contraction. For these reasons, eccentric exercise is a valid method of muscle strengthening in rehabilitation and in particular in those subjects unable to sustain a high cardiorespiratory effort, as in the case of patients with moderate-severe COPD. Previous studies have also shown that eccentric exercise, even at low load, produces results equivalent if not superior to traditional training with respect to some particular characteristics of muscle function such as power and hypertrophy. However, eccentric training programs for muscle dysfunction recovery in patients with COPD are underused in clinical practice, so far. In contrast, the so called iso-weight eccentric training, more suitable for clinical practice, could also be applied to rehabilitation programs designed for COPD patients. The aim of this study is therefore to evaluate the reliability and efficacy of a low-load eccentric exercise training program compared to usual care for the improvement of muscle function in patients with COPD.

Conditions

Copd

Keywords

Copd; Pulmonary rehabilitation; Muscle strength; Resistance training

Outcome Measures

Primary Outcomes (1)

• Maximal muscle strength

  Isometric peak torque of the quadriceps.

  Change from baseline up to 4 weeks

Secondary Outcomes (6)

• Six-minute walk distance

  Change from baseline up to 4 weeks

• Mobility function

  Change from baseline up to 4 weeks

• Muscle function

  Change from baseline up to 4 weeks

• Body composition

  Change from baseline up to 4 weeks

• Airways resistance

  Change from baseline up to 4 weeks

Study Arms (2)

Eccentric training group

EXPERIMENTAL

Other: Low-load eccentric training

Control group

ACTIVE COMPARATOR

Other: Usual care

Interventions

Low-load eccentric training OTHER

* Aerobic exercise training on a downhill walking treadmill with the following settings: 10% negative incline and constant speed corresponding to 75% of the average speed recorded during the initial 6-Minute walk test. * Resistance training: 5 minutes of warm-up on the manual ergometer, then 3 sets for 10 repetitions of the leg extension (performed unilaterally in eccentric phase) with a load of 75% of 1 repetition maximum (concentric) for the first two weeks. The following two weeks, 3 sets for 10 repetitions will be performed on the leg press (performed unilaterally in the eccentric phase) with 75% load of 1 repetition maximum (concentric). In addition, patients will perform 3 upper extremity strengthening exercises (free weights or elastic bands), including 2 sets of 10 repetitions for each exercise.

Eccentric training group

Usual care OTHER

* Aerobic exercise training using the cycle ergometer at an intensity calculated as follows: 2 minutes with load equal to 20% of maximum load, then 25 minutes with initial load at 50% of maximum load calculated as 103.217 + (30.500xGender) + (-1.613xAge) + \[0.002x6-Minute walk work (6MWW)\]. \[Sex: female = 0; male:1\] \[6MWW = 6-Minute walk distance x weight in kg\]. * Resistance training: 5 minutes of warm-up on the manual ergometer, then 5 exercises for upper and lower limbs performed with free weights or elastic bands. For the first 2 weeks will be performed 2 sets X 20 repetitions with 1 minute break between sets and a load that allows to perform no more than 20 repetitions. For the following 2 weeks, 3 sets of 10 repetitions x 10 repetitions with 2 min break between sets and a load that allows for no more than 10 repetitions.

Control group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnosis (GOLD stage: II-III-IV), defined as post-bronchodilator forced expiratory volume in 1s (FEV1)/forced vital capacity \< 0.7 and FEV1 \< 80% predicted.

You may not qualify if:

• Restrictive lung disease, unstable conditions, recent exacerbation, infection, embolism, pneumothorax, thoracic or abdominal surgery (less than 3 months before recruitment).
• Cardiologic conditions like myocardial infarction (less than 6 months before recruitment), heart failure, or severe angina.
• Inability of perform the exercise training (e.g. orthopaedic conditions).
• Incapability to understand the instructions required to carry out the tests and assessments planned.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20100, Italy

Location

Related Publications (17)

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  PMID: 27647157 BACKGROUND

• Franchi MV, Maffiuletti NA. Distinct modalities of eccentric exercise: different recipes, not the same dish. J Appl Physiol (1985). 2019 Sep 1;127(3):881-883. doi: 10.1152/japplphysiol.00093.2019. Epub 2019 May 9. No abstract available.

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• Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.

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  PMID: 14979497 BACKGROUND

• Pancera S, Lopomo NF, Porta R, Sanniti A, Buraschi R, Bianchi LNC. Effects of Combined Endurance and Resistance Eccentric Training on Muscle Function and Functional Performance in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Mar;105(3):470-479. doi: 10.1016/j.apmr.2023.09.004. Epub 2023 Sep 15.

  PMID: 37716519 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 8, 2021
• Study Start: September 13, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-03

Locations

IT (1)