Clinical trial NCT01977469: Randomized Controlled Study to Investigate the Impact of Different Intensities Training on ADL and BODE Index in COPD
Official title: Impact of Aerobic and High and Low Resistance Training on Daily Life Activities and BODE Index COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Activities of Daily Living
Mortality
Strength Training
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-11-06
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The local and systemic manifestations that affect patients with Chronic Obstructive Pulmonary Disease (COPD) cause severe dyspnoea and limitation of functional capacity, leading to impairment in the performance of activities of daily living (ADL). The combination of aerobic and resistance training, for both upper limbs (UL) and lower limbs (LL), appears to be the physiologically most complete resource for improving quality of life and increased survival of these patients. Therefore, the aim of the study is to assess the impact of aerobic and resistance training of different intensities on the performance and dyspnoea during activities of daily living and prediction of mortality in patients with COPD. There will be include 45 COPD patients with moderate to severe obstruction, aged between 50-80 years of both gender. All patients will undergo to the following assessments and reassessments: history and anthropometric data, Scale London Chest Activity of Daily Living Scale (LCADL), modified Medical Research Council (mMRC), BODE index, test peripheral muscle strength, mobility and balance tests, 6-minute walk test (6MWT), Circuit ADL Test, 1 repetition maximum (1RM) and Incremental Cardiopulmonary Testing (ICPT). Patients will be randomly divided into two groups and undergo to the treatment program will consist of sessions lasting approximately 1 hour, three times a week for 12 consecutive weeks, totaling 36 sessions. All patients will undergo general stretching and aerobic training on a cycle ergometer with the intensity between 70-80 % of the maximum load achieved in ICPT. After aerobic training, a group of patients will achieve a protocol of low-intensity resistance training (LI-RT), with emphasis on gaining muscle strength, and the other group will be submitted to a protocol of high intensity (HI-RT), aiming greater gain in muscle strength. The calculation of the intensity of training will be conducted by the 1RM test. After the training protocol, it is expected to find improved performance and dyspnoea during activities of daily living and reduction of BODE index for both groups, however, it is expected that the group of low-intensity resistance training presents greater benefits in ADL.


Eligibility criteria: Inclusion Criteria:Patients both genders, with a clinical diagnosis of COPD confirmed by post bronchodilator spirometry administered by a pneumologist, classified as moderate to very severe obstruction in accordance with the GOLD criteria; ex- or non-smokers; oxygen dependent or not; clinically stable; no history of infection and no exacerbation of respiratory symptoms or changes in medication for at least two months before the study and that no present cardiac, rheumatic or an associated orthopedic disease that prevent them from performing the proposed evaluation tasks.

Exclusion Criteria:Patients who present respiratory, cardiac, rheumatic, musculoskeletal, orthopedic and neuromuscular sequels that may prevent the testing and intervention proposal; that to modify the type of medication during the study; in cases of uncontrolled hypertension or refusal to provide consent proposed in the Resolution of National Council of Health.

Primary outcomes:
measure: Change in Oxygen Saturation During Activities of Daily Living
timeFrame: Baseline and after 36 sessions, an average of 3 months
measure: Change in Ventilation During Activities of Daily Living
timeFrame: Baseline and after 36 sessions, an average of 3 months
measure: Change in Oxygen Consumption During Activities of Daily Living
timeFrame: Baseline and after 36 sessions, an average of 3 months
measure: Change in Dyspnea Related During Activities of Daily Living
timeFrame: Baseline and after 36 sessions, an average of 3 months
Secondary outcomes:
measure: Change in BODE index
timeFrame: Baseline and after 36 sessions, an average of 3 months
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Special Respiratory Physiotherapy Unit of the Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Valéria Amorim Pires Di Lorenzo, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Sao Carlos
name: Júlia Gianjoppe dos Santos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Sao Carlos
name: Marina Sallum Barusso, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
citation: Beauchamp MK, O'Hoski S, Goldstein RS, Brooks D. Effect of pulmonary rehabilitation on balance in persons with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2010 Sep;91(9):1460-5. doi: 10.1016/j.apmr.2010.06.021.
citation: Bernard S, LeBlanc P, Whittom F, Carrier G, Jobin J, Belleau R, Maltais F. Peripheral muscle weakness in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Aug;158(2):629-34. doi: 10.1164/ajrccm.158.2.9711023.
citation: Clini E, Costi S, Romagnoli M, Florini F. Rehabilitation of COPD patients: which training modality. Monaldi Arch Chest Dis. 2004 Jul-Sep;61(3):167-73. doi: 10.4081/monaldi.2004.697.
citation: Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.
citation: Eisner MD, Blanc PD, Yelin EH, Sidney S, Katz PP, Ackerson L, Lathon P, Tolstykh I, Omachi T, Byl N, Iribarren C. COPD as a systemic disease: impact on physical functional limitations. Am J Med. 2008 Sep;121(9):789-96. doi: 10.1016/j.amjmed.2008.04.030.
citation: Man WD, Kemp P, Moxham J, Polkey MI. Skeletal muscle dysfunction in COPD: clinical and laboratory observations. Clin Sci (Lond). 2009 Aug 17;117(7):251-64. doi: 10.1042/CS20080659.
citation: Ortega F, Toral J, Cejudo P, Villagomez R, Sanchez H, Castillo J, Montemayor T. Comparison of effects of strength and endurance training in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 1;166(5):669-74. doi: 10.1164/rccm.2107081.
citation: O'Shea SD, Taylor NF, Paratz JD. Measuring muscle strength for people with chronic obstructive pulmonary disease: retest reliability of hand-held dynamometry. Arch Phys Med Rehabil. 2007 Jan;88(1):32-6. doi: 10.1016/j.apmr.2006.10.002.
citation: Panton LB, Golden J, Broeder CE, Browder KD, Cestaro-Seifer DJ, Seifer FD. The effects of resistance training on functional outcomes in patients with chronic obstructive pulmonary disease. Eur J Appl Physiol. 2004 Apr;91(4):443-9. doi: 10.1007/s00421-003-1008-y. Epub 2003 Nov 25.
citation: Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
citation: Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7.
citation: Troosters T, Casaburi R, Gosselink R, Decramer M. Pulmonary rehabilitation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Jul 1;172(1):19-38. doi: 10.1164/rccm.200408-1109SO. Epub 2005 Mar 18. No abstract available.
citation: Velloso M, Stella SG, Cendon S, Silva AC, Jardim JR. Metabolic and ventilatory parameters of four activities of daily living accomplished with arms in COPD patients. Chest. 2003 Apr;123(4):1047-53. doi: 10.1378/chest.123.4.1047.
citation: Wedzicha JA, Bestall JC, Garrod R, Garnham R, Paul EA, Jones PW. Randomized controlled trial of pulmonary rehabilitation in severe chronic obstructive pulmonary disease patients, stratified with the MRC dyspnoea scale. Eur Respir J. 1998 Aug;12(2):363-9. doi: 10.1183/09031936.98.12020363.
citation: Barusso MS, Gianjoppe-Santos J, Basso-Vanelli RP, Regueiro EM, Panin JC, Di Lorenzo VA. Limitation of Activities of Daily Living and Quality of Life Based on COPD Combined Classification. Respir Care. 2015 Mar;60(3):388-98. doi: 10.4187/respcare.03202. Epub 2014 Dec 9.