Eccentric Training in Individuals With COPD

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04785469

Collaborator

(none)

Enrollment

Location

Arms

13.6

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Copd	Other: Low-load eccentric training Other: Usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Impact of a Low-load Eccentric Training Program on Peripheral Muscle Function in Patients With Chronic Obstructive Pulmonary Disease

Actual Study Start Date :

Sep 13, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eccentric training group	Other: Low-load eccentric training 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.
Active Comparator: Control group	Other: Usual care 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.

Arm

Intervention/Treatment

Experimental: Eccentric training group

Other: Low-load eccentric training

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.

Active Comparator: Control group

Other: Usual care

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.

Outcome Measures

Primary Outcome Measures

Maximal muscle strength [Change from baseline up to 4 weeks]
Isometric peak torque of the quadriceps.

Secondary Outcome Measures

Six-minute walk distance [Change from baseline up to 4 weeks]
The distance that an individual can walk on an indoor 30-m flat corridor for a 6-min period.
Mobility function [Change from baseline up to 4 weeks]
The Short Physical Performance Battery (SPPB) is a test made by 3 components (standing balance, 4-m gait speed, and 5-repetitions sit-to-stand) measured by total time and kinematic parameters.
Muscle function [Change from baseline up to 4 weeks]
Measures of muscle accuracy and steadiness intended as the ability to control muscle force performing submaximal contractions during standardized tasks.
Body composition [Change from baseline up to 4 weeks]
Fat-free mass Index (FFM; calculated as the sum of lean mass and bone mineral mass)
Airways resistance [Change from baseline up to 4 weeks]
Measure of airway Resistance [Rrs (cmH2O/L/s)]
Airways reactance [Change from baseline up to 4 weeks]
Measure of airway Reactance [Xrs (cmH2O/L/s)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Fondazione Don Carlo Gnocchi	Milan		Italy	20100

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT04785469

Other Study ID Numbers:

Eccentric Training_COPD_FDG

First Posted:

Mar 8, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Don Carlo Gnocchi Onlus

Copd

Pulmonary rehabilitation

Muscle strength

Resistance training

Study Results

No Results Posted as of Apr 4, 2022