Randomized Controlled Study to Investigate the Impact of Different Intensities Training on ADL and BODE Index in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Impact of Aerobic and High and Low Resistance Training on Daily Life Activities and BODE Index COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977469
• Other study ID #: EditalUniversal2011
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2019
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Low intensity resistance training
The LIRT group initiated the resistance training for UL with 30% of the 1RM, with 5% increases each nine sessions; therefore, the maximum load was 45% of the 1RM. The LL training initiated with 30% of the 1RM, increasing 7% each nine sessions, thus, the maximum load was 51% of the 1RM. Each exercise session consisted of three sets of 15 repetitions, with a 2 minutes interval between sets.
• High intensity resistance training
the initial load for HIRT group was 60% of 1RM for UL with 5% increases each nine sessions; therefore, the maximum load reached 75% of the 1RM. The LL training initiated with 60% of the 1RM with 7% increments each nine sessions, as a result, the maximum load after 36 sessions was 81% of the 1RM. These patients underwent three sets of eight repetitions, with two minutes intervals between sets.
• Aerobic training
Patients underwent an aerobic training in cycle ergometer, with load intensity determined as the same load the patient presented a VO2 value of 70-80% of the peak VO2 obtained in the symptom-limited CPET. Each session of aerobic training lasted 20-30min according to patient's tolerance.

Locations

Country	Name	City	State
Brazil	Special Respiratory Physiotherapy Unit of the Federal University of São Carlos	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (15)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Ortega F, Toral J, Cejudo P, Villagomez R, Sánchez 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. — View 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. Epub 2003 Nov 25. — View 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. Epub 2007 May 16. Review. — View 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. Epub 2006 Nov 7. — View 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. Epub 2005 Mar 18. Review. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oxygen Saturation During Activities of Daily Living	TThe ADL performance was assessed by an adapted laboratory circuit of ADL, including: Showering, lifting and lowering containers on a shelf above the shoulder girdle, and raising and lowering pots on a shelf below the pelvic girdle.; Oxygen saturation (SpO2, %) was assessed by pulse oxymeter.	Baseline and after 36 sessions, an average of 3 months
Primary	Change in Ventilation During Activities of Daily Living	The ADL performance was assessed by an adapted laboratory circuit of ADL, including: Showering, lifting and lowering containers on a shelf above the shoulder girdle, and raising and lowering pots on a shelf below the pelvic girdle.; Ventilation (VE-l/min) was captured by a portable metabolic system.	Baseline and after 36 sessions, an average of 3 months
Primary	Change in Oxygen Consumption During Activities of Daily Living	The ADL performance was assessed by an adapted laboratory circuit of ADL, including: Showering, lifting and lowering containers on a shelf above the shoulder girdle, and raising and lowering pots on a shelf below the pelvic girdle. Gas exchange (oxygen consumption - VO2-l/min) was captured by a portable metabolic system.	Baseline and after 36 sessions, an average of 3 months
Primary	Change in Dyspnea Related During Activities of Daily Living	Dyspnea in ADL was assessed by London Chest Activity of Daily Living Scale(LCADL), that consists 15 quantitative questions of 4 domains: self-care, domestic, physical, and leisure. Subjects indicate a score of 0-5, in a total of 75 points. A higher total score indicates greater limitation in performing ADL due to dyspnea.	Baseline and after 36 sessions, an average of 3 months
Secondary	Change in BODE index	In order to calculate the BODE index, the following variables were considered: BMI (body mass index), forced expiratory volume in one second, as the percentage of the predicted value (pred FEV1 %), mMRC score (modified Medical Research Council Scale) and in the 6MWD (Six-Minute Walk Distance). The score was considered according to the results obtained from the four variables (0-3 for FEV1; 0-3 for mMRC; 0-3 for 6MWD and 0-1 for BMI), and total score ranged from 0 to 10 (higher scores indicate more severity).	Baseline and after 36 sessions, an average of 3 months