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

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Behavioral: Low intensity resistance training
Behavioral: High intensity resistance training
Behavioral: Aerobic training
Registration Number
NCT01977469
Lead Sponsor
Universidade Federal de Sao Carlos
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Low intensity resistance trainingAerobic trainingLow intensity resistance training + aerobic training
High intensity resistance trainingAerobic trainingHigh intensity resistance training + aerobic training
Low intensity resistance trainingLow intensity resistance trainingLow intensity resistance training + aerobic training
High intensity resistance trainingHigh intensity resistance trainingHigh intensity resistance training + aerobic training
Primary Outcome Measures
NameTimeMethod
Change in Oxygen Saturation During Activities of Daily LivingBaseline and after 36 sessions, an average of 3 months

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.

Change in Ventilation During Activities of Daily LivingBaseline and after 36 sessions, an average of 3 months

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.

Change in Dyspnea Related During Activities of Daily LivingBaseline and after 36 sessions, an average of 3 months

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.

Change in Oxygen Consumption During Activities of Daily LivingBaseline and after 36 sessions, an average of 3 months

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.

Secondary Outcome Measures
NameTimeMethod
Change in BODE indexBaseline and after 36 sessions, an average of 3 months

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).

Trial Locations

Locations (1)

Special Respiratory Physiotherapy Unit of the Federal University of São Carlos

🇧🇷

São Carlos, São Paulo, Brazil

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