Clinical trial NCT02522637: Exercise Training in Severe COPD
Official title: What is the Best Frequency of Exercise Training in Severe COPD?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: exercise
training
endurance
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
Collaborators: name: Villa Pineta Hospital
First posted: 2015-08-13
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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. 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.

Detailed description: Rehabilitation in-hospital program

The rehabilitation program (RP) will start the day after the in-hospital admission and will be continuously supervised by a physiotherapist. The patients will use the drugs and the oxygen therapy prescribed. RP will include a training session on cycloergometer at constant load once a day (Group F1) or twice-a day (Group F2) interrupted by at least three hours of rest. 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.

Measures

At baseline (T0) we will gather in both groups the following evaluations:

1. Anthropometric parameters (age, BMI)
2. Scale of comorbidity CIRS

At the baseline (T0) and end of the program (T1) we will collect, in all patients, the following evaluations:

1. 6-minute walking test walk (6MWT) will be performed according to international guidelines. In patients using oxygen during walking, the oxygen flow will be adjusted to increase the oxygen saturation over 96%.The 6MWT at T1 will be performed with the same amount of oxygen used in the initial test (T0).
2. Endurance cycloergometer test will be performed at 80% of Watts max predicted by the 6MWT. At the beginning, the test will be performed at charge "zero watts" for 2 minutes, then the workload will be increased to 80% of the theoretical max Watts until muscle exhaustion (Borg score \> 8), presence of high dyspnea (Borg score \> 8) or the achievement of 90% of theoretical maximal heart rate. The final endurance test will be repeated at the same load (speed 50-60 rpm). The time spent for performing the exercise will be registered. In a subset of patients (belonging to the Institute of Lumezzane) the endurance cycloergometer test on the quadriceps muscle will be executed by the Near Infrared Spectroscopy (NIRS ).
3. Scale of the MRC dyspnea
4. Arterial blood gas analysis
5. Respiratory muscle strength (Maximal lnspiratory Pressure \[MIP\] and Maximal Espiratory Pressure \[MEP\])
6. Biceps and quadriceps muscle strength evaluated with dynamometer manual
7. CAT scale

Only at the end of the program (T1) we will collect:

1. patient satisfaction by a Likert scale taking into consideration the quantity, quality, and impact of rehabilitation on hospitalization
2. The time consuming for the two programs
3. The side effect
4. The drop out (waste, flare)

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Endurance cycloergometer test: difference between F1 and F2 programs (time needing for the test execution)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri
state: Brescia
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Mara Paneroni, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.