Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03417908
Other study ID # 09-411
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 4, 2017
Est. completion date December 14, 2018

Study information

Verified date February 2018
Source Universidade Federal do Pampa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD.


Description:

All subjects (sixty men) will perform spirometry, measure of inspiratory capacity (IC) and maximal inspiratory and expiratory pressures (MIP and MEP). Baseline blood pressure (BP), respiratory rate (RR), heart rate (HR), sensation of dyspnea (Borg Scale) and oxygen saturation (pulse oximetry, SpO2) will be collected prior to the performance of pulmonary function tests.

The electrical activity of the scalene (ESC), sternocleidomastoid (SCM) and external intercostal muscles (INTER) will be measured by surface electromyography (sEMG) at rest and during the maneuvers of IC, MIP and MEP.

Control group: The control group will perform isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

Intervention group: The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) is maintained for 6 seconds. After that, the patient will be asked to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.

Statistical analysis will be carried out with the Statistical Package for the Social Sciences, version 18.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be assessed by the Shapiro-Wilk test.

Values will be presented as mean ± standard deviation (SD) or median (25-75%). To compare the differences between the baseline characteristics between the groups the t test for independent samples will be used. The effect of the intervention will be evaluated by paired t test. For the analysis of the electromyographic signal will be use the Wilcoxon T test. Statistical significance is accepted at p < 0.05.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 14, 2018
Est. primary completion date December 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Control group: Men without respiratory symptoms and lung disease, with normal spirometry.

- Interventional group: Men diagnosed with severe to very severe COPD (forced expiratory volume in one second / forced vital capacity - FEV1/FVC <0.7 and FEV1 <50% predicted after bronchodilator use); clinically stable over the past 4 weeks.

Exclusion Criteria:

- History of fracture in the spine and / or upper limb

- Herniated disc

- Connective tissue disease

- Ischemic heart disease or uncontrolled hypertension

- Obesity (BMI> 30 kg/m2)

- Aortic aneurysm

- Recent abdominal or thoracic surgery

- Glaucoma

- Retinal detachment

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PNF
The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.
Sham
Isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

Locations

Country Name City State
Brazil Anelise Dumke Uruguaiana Rio Grande Do Sul

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal do Pampa Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in inspiratory capacity Change in inspiratory capacity One day
Secondary Change in maximal respiratory pressure (MIP and MEP) Change in maximal respiratory pressure (MIP and MEP) One day
Secondary Change in electromyographic activity of accessory respiratory muscles Change in electromyographic activity of accessory respiratory muscles One Day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06000696 - Healthy at Home Pilot
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04105075 - COPD in Obese Patients
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting NCT04075331 - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial Phase 2/Phase 3
Terminated NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn NCT04210050 - Sleep Ventilation for Patients With Advanced Hypercapnic COPD N/A
Terminated NCT03284203 - Feasibility of At-Home Handheld Spirometry N/A
Recruiting NCT06110403 - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness Phase 1/Phase 2
Active, not recruiting NCT06040424 - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Completed NCT04485741 - Strados System at Center of Excellence
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A