Resistance training in clinical, inflammatory process control in patients with moderate, severe and difficult control asthma.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-4tbd4p
• Date of registration: 11/05/2012
• Primary sponsor: Universidade Nove de Julho - São Paulo, SP, Brazil
• Public title: Resistance training in clinical, inflammatory process control in patients with moderate, severe and difficult control asthma.
• Scientific title: Resistance training in clinical, inflammatory process control in patients with moderate, severe and difficult control asthma.
• Date of first enrolment: 15/01/2012
• Target sample size: 40
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4tbd4p/
• Study design: Therapeutic, cross-over, with 2-arms, double-blinded, randomized clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Luciana Sampaio
• Affiliation: Universidade Nove de Julho

• Name: Luciana Sampaio
• Affiliation: Universidade Nove de Julho

Key inclusion & exclusion criteria

Inclusion criteria: In medical treatment-outpatient for at least six months;
Clinical picture stable for three months; Optimized drug therapy.
Exclusion criteria: Heart disease associated with pulmonary disease;
Musculoskeletal pathology that may interfere with the conduct of reviews or exercises;
Pulmonary hypertension;
Difficulty to learn.

Age minimum: 17
Age maximum: 55
Gender: -

Health Condition(s) or Problem(s) studied

Asthma, Quality of life
C08.127.108
I01.800

Intervention(s)

The subject will be initially evaluated and randomized into 2 groups (1 Group (intervention)-20 participants and group 2 (control)-20 participants) and subjected to resistance training and educational program. After 12 weeks, all subjects shall be reassessed and the last evaluation will happen at the end of the training program. Educational program: enable the patient to participate actively in its treatment seeking in this way optimize it. The program will consist of two classes, one per week, lasting 2:0. The programmatic content will cover: the) know what is asthma, which slows the disease and how to avoid the trigger factors; b) use appropriate medications for each patient and with the proper technique; c) know how to recognize when the asthma is coming out of control, and how to act in the presence of an exacerbation; d) know the side effects of the medications used and understand how to minimize them; and learn to monitor their illness) using the peak flow meter. The lessons will be given in the form of lectures and group discussion. Program of resistance training: the training program will last 12 weeks beginning the week following the end of the implementation of the educational program. Patients will begin with an initial 70 maximum repetition (1RM: the maximum load which can be moved only once on the full range of motion without compensatory movements) in the first week (3 x 8 reps). Each week the load will be increased by 5 of the 1RM.

Primary Outcome(s)

Reduction of inflammatory process ápós resistance training, assessed by analysing the levels of cytokines by ELISA. Levels of interleukin-2 (IL-2), IL-4, IL-5 and IFN as well as levels of leukotrienes are analysed using commercial kits of enzyme immunoassay (EIA). All samples will be evaluated in duplicates. Improves lung function, evaluated through the procedure of simple pulmonary function test performed respecting the rules of CONSENSUS I BRAZILIAN SPIROMETRY (1996). The dynamic indices obtained will be: forced vital capacity (FVC); Forced Expiratory volume in one second (Fev1); peak flow (PFE) and forced expiratory flow 25-75; Tiffeneau index (VEF1CVF); and maximum voluntary ventilation (VVM). Increased quality of life, evaluated using the questionnaire of quality of life for asthma that evaluates the domains: physical limitation (activities of daily living and leisure), frequency, and severity of symptoms, adherence to treatment, psychosocial and socioeconomic situation. Should be applied by an interviewer, who is not involved with the study, and that will be trained not to interpret the questionnaire for patients. Decrease in anxiety and depression, measured through the self-esteem that will be evaluated by Rosemberg scale. As regards the other variables will be used the questionnaires of BECK et al. for anxiety and depression SPEILBERGER et al. questionnaires are applied by an interviewer that is not involved with the study-oriented, not provide interpretations for patients. Decrease of clinical symptoms, analysed by a journal designed specifically for this job, but based on a previously described (Robles, 2003). The journals will be filled out daily by patients and include questions about the emergence of crises and symptoms (cough, wheezing, shortness of breath, "" wake up the night ", using" firecrackers "). The days free from any of the symptoms will be totaled and considered monthly. Increased peak Expiratory flow values (PFE), assessed through the daily log of PFE. Concomitant to the registry of maximum voluntary contraction will be recorded electrical activity and the amplitude of the action potential (wave M) of the lateral deltoid, Vastus, Pectoral and dorsi dominant member by surface electromyography (EMGs) at a sampling frequency of 1000 Hz. collects will be used two surface electrodes associated with a conductive gel that will be adhered to the skin over the muscle belly of lower limb muscles (side wide, isquitibiais) and upper limb (kite, tricipes brachii and biceps brachii) being the electrodes positioned between the engine and the distal tendon to eletromiográfico signal capture. After the capture and EMGs are dropped the record first and last 10 seconds, staying 10 seconds for the effective analysis of muscle activation. Obtaining the signal will be amplified and converted to digital format for record and analysis of data, and the outcome variable of this measure the average square root (RQM) which quantifies the amount of muscular activity and the median frequency (FM) which reflects the rate of firing of the traction unit. The signal is recorded and stored on a personal computer for subsequent analysis. To get the peak of strength will be used a load cell.

Secondary Outcome(s)

Increasing peripheral muscle strength after resistance training, assessed by testing of maximum force. Before the performance of the tests of 1 repetition (1RM), patients will search four training sessions for learning exercises. After this period, the load test will be applied to assess the 1RM maximum strength exercises: supine straight (SR), leg press (LP), pulled behind (en), hack (HACK), 45th biceps with dumbbells (RB), leg extension (EP) and triceps doughnut in the pulley (RT). Decreased level of respiratory discomfort against determined physical effort, evaluated by numerical scale of Borg modified, ranging from 0 (lowest effort) to 10 (most effort). Decreased heart rate variability (FC), evaluated by the test of variability of FC held on an air-conditioned laboratory with temperatures between 22 and 24° C and air humidity between 50 and 60, in the same period of the day (between 8:0 and 12:0). For the day before and on the day of the test, each volunteer will receive the following guidelines: avoid stimulating beverages (tea, coffee, alcoholic beverages ...), not to make physical activity, perform light meals and have a proper night's sleep (at least 8:0). Before the start of collections, participants will be questioned and examined – systolic blood pressure measurement (PAS) and diastolic arterial pressure (PAD), heart rate (HR), listens to pulmonary and peripheral oxygen saturation. Initially the volunteers will be kept for approximately 10 min to sleep in the supine position so that the FC reaches the basal values. Instant will be collected later FC during 15 min at rest in the supine position. During the gathering, the volunteers will be geared not to speak, not moving and keep your breath and spontaneous in orthostatic position. Throughout the procedure patients are being monitored by polar frequency.

Secondary ID(s)

CAAE - 0261.0.241.000-08

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq - SP, Brazil

Secondary Sponsor(s)

Universidade Nove de Julho - São Paulo, SP, Brazil