Exercise Training in Severe COPD

NCT02522637 | Completed

• 1 other identifier: Fondazione Salvatore Maugeri
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate COPD patients looking at the work setting, programs and frequency of training sessions in an outpatient program of rehabilitation. However, a new population of respiratory patients is growing: these are more serious and older patients, with several comorbidities and recurrent hospitalizations. In this population no guidelines are available to describe the optimum prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In this kind of patients, only few studies are available on the overtraining risk. The aims of the current study are:

1. 1.To detect and compare the response in terms of endurance of two endurance training programs with different time-frequencies (1 session / day versus 2 sessions / day) during 30 days of in-hospital admission to a pulmonary rehabilitation center
2. 2.To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and respiratory muscle strength, quality of life and psychological and functional impact of the disease.

Conditions

COPD

Keywords

exercise; training; endurance

Outcome Measures

Primary Outcomes (1)

• Endurance cycloergometer test: difference between F1 and F2 programs (time needing for the test execution)

  Evaluation of the time needing for the test execution

  30 days

Study Arms (2)

Exercise training F1

ACTIVE COMPARATOR

Patients will be treated with a specific rehabilitation in-hospital program consisting of one daily sessions of 30 minutes of exercise (Frequency 1 : Program F1 )

Other: Exercise training

Exercise training F2

EXPERIMENTAL

Patients will be treated with a specific rehabilitation in-hospital program consisting of two daily sessions of 30 minutes of exercise (Frequency 2 : Program F2 )

Other: Exercise training

Interventions

Exercise training OTHER

The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al. Each training session will begin with three minutes of warm-up and cool-down with a low load. At the end of each session, the physiotherapist will administer the Borg Scale (i.e. for dyspnea and muscle fatigue) and detect the oxygen saturation. The sessions will be conducted at constant load for 25 minutes and increase following the Maltais protocol (the workload increase in the next session will be 10 W, if dyspnea and muscle fatigue, evaluated at the Borg Scale, were each \< 5 ). The patients will perform a supervised 20-min light warm-up gym exercise before the endurance training session. The training will be carried out with the oxygen level necessary to maintain the saturation level ≥ 91%.

Exercise training F1; Exercise training F2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 40 to 80 years
• Diagnosis of moderate to severe COPD ( GOLD III and IV ) with clinical stability ( pH\> 7.38 and no need to change prescription of respiratory drugs in the last 10 days).

You may not qualify if:

• Patients with respiratory failure in absence of COPD
• Patients who had attended a pulmonary rehabilitation program in the last 6 months
• Patients with a recent myocardial infarction (in the last 3 months)
• Patients with congestive heart failure
• Patients with severe orthopedic diseases
• Patients with psychiatric illness and severe cognitive impairment.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead
• Villa Pineta Hospital: collaborator

Study Sites (1)

Fondazione Salvatore Maugeri

Lumezzane, Brescia, 25065, Italy

Location

Related Publications (5)

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

  PMID: 24127811 BACKGROUND

• Luxton N, Alison JA, Wu J, Mackey MG. Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology. 2008 Nov;13(6):856-62. doi: 10.1111/j.1440-1843.2008.01355.x.

  PMID: 18811884 BACKGROUND

• Brooks D, Solway S, Gibbons WJ. ATS statement on six-minute walk test. Am J Respir Crit Care Med. 2003 May 1;167(9):1287. doi: 10.1164/ajrccm.167.9.950. No abstract available.

  PMID: 12714344 BACKGROUND

• Hook JL, Arcasoy SM, Zemmel D, Bartels MN, Kawut SM, Lederer DJ. Titrated oxygen requirement and prognostication in idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):359-65. doi: 10.1183/09031936.00108111. Epub 2011 Sep 1.

  PMID: 21885386 BACKGROUND

• Paneroni M, Vogiatzis I, Belli S, Savio G, Visca D, Zampogna E, Aliani M, Carolis V, Maniscalco M, Simonelli C, Vitacca M. Is Two Better Than One? The Impact of Doubling Training Volume in Severe COPD: A Randomized Controlled Study. J Clin Med. 2019 Jul 18;8(7):1052. doi: 10.3390/jcm8071052.

  PMID: 31323895 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mara Paneroni, PT

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: August 13, 2015
• Study Start: May 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)