Acute Effect of Whole-body Electrical Stimulation in ILD Patients
- Conditions
- ILD
- Interventions
- Other: whole-body electrical stimulation
- Registration Number
- NCT06167811
- Lead Sponsor
- Federal University of Health Science of Porto Alegre
- Brief Summary
Patients with interstitial lung disease present, in addition to respiratory symptoms, peripheral muscle dysfunction, which contributes to functional impairment. The aimof the study is to investigate the safetyof whole-body electrical stimulation in patients with interstitial lung disease (ILD). Patients Will perform two different EECI protocols, with na intervalo fone week between them. First the patients Will be submitted to the evaluation of the autonomic control. After a blood collection and measurement of muscles trength will be performed. The verification of vital signs: BP, SpO2, HR, FR and the perception of dyspnea and fatigue (BORG) Will occur immediately before and after the EECI session. During the protocol, SpO2, HR, RR and BORG Will be checked. After the session, a new blood collection Will be performed and autonomic control and muscle strength Will be reassessed. After 24, 48 and 72 hours, new blood samples Will be collected and muscle pain Will be measured.
- Detailed Description
Patients with ILD will be submitted to two whole body electrostimulation protocols, with an interval of one week between them. Miha Bodytec equipment will be properly calibrated, with electrodes on the quadriceps, hamstrings, glutes, biceps, triceps, pectorals, abdomen, trapezius, latissimus dorsi and quadratus lumborum muscles. Symmetric pulsed biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds. Protocol 1 will take eight minutes resulting in 32 muscle contractions, and protocol 2 will take 16 minutes resulting in 64 muscle contractions. Initially, patients will undergo an assessment of autonomic control. Then, blood collection will be performed, the serum lactate level will be checked and muscle strength will be measured. Verification of systolic blood pressure, diastolic blood pressure, peripheral oxygen saturation, heart rate, respiratory rate and perception of dyspnea and fatigue (BORG) will occur immediately before and after the whole body electrical stimulation session. During the protocol, peripheral oxygen saturation, heart rate, respiratory rate and BORG will be checked. After the session, the serum lactate level will be checked, a new blood collection will be performed and autonomic control and muscle strength will be reassessed. After 24, 48 and 72 hours, new blood samples will be collected and muscle pain will be measured.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 8
- Diagnosis of interstitial lung disease;
- Age between 18 and 80 years;
- Ability to ambulate.
- Cognitive dysfunction that prevents assessments from being carried out, as well as inability tounder standand sign the informed consent form (ICF);
- Intolerance to the electrostimulator and/or change in skin sensitivity;
- Patients with stroke sequelae;
- Recent acute myocardial infarction (two months);
- Uncontrolled hypertension;
- New York Heart Association grade IV heart failure or decompensated;
- Unstable angina or arrhythmia;
- Peripheral vascular changes in lower limbs such as deepvein thrombosis;
- Disabling osteoarticular or musculo skeletal disease;
- Uncontrolled diabetes (glycemia> 300mg/dL);
- Patients with câncer and/or under going câncer treatment;
- Patients with systemic disease or other autoimmune disease;
- Artificial cardiac pace maker;
- Epilepsy;
- Hemophilia;
- Live rand kidney diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description whole-body electrical stimulation, Protocol 2 whole-body electrical stimulation A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for 16 minutes, totaling 64 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings. whole-body electrical stimulation, Protocol 1 whole-body electrical stimulation A whole body electrical stimulation session. Symmetrical biphasic current will be used, pulse width of 400µs, frequency of 75Hz, contraction time of five seconds, rest time of 10 seconds, for eight minutes, totaling 32 muscle contractions. During the first two minutes of stimulation, the patient will remain in isometry to become familiar with the electrical current. Then with the use of a stick (for proprioception), a series of biceps exercises and a series of triceps exercises, a series of sit-ups and a squat, a series of step ups and downs, and a series of plantings.
- Primary Outcome Measures
Name Time Method Respiratory rate Immediately after the session Respiratory rate will be assessed by respiratory rate count for one minute
Dyspnea and fatigue Immediately after the session Dyspnea and fatigue will be assessed using a subjective perceived exertion scale ranging from 0 to 10, where 0 indicates no dyspnea and 10 indicates maximum dyspnea.
Peripheral oxygen saturation Immediately after the session Peripheral oxygen saturation will be assessed by pulse oximetry
Systolic blood pressure Immediately after the session Systolic blood pressure will be assessed through sphygmomanometer
Diastolic blood pressure Immediately after the session Diastolic blood pressure will be assessed through sphygmomanometer
Heart rate Immediately after the session Heart rate will be assessed by pulse oximetry
Autonomic control up to 10 minutes after the session Autonomic control will be assessed through variability heart rate
Adverse events 72 hours after the session Occurence of adverse events will be assessed through patient report
- Secondary Outcome Measures
Name Time Method Muscle damage 72 hours after the session Assessed through the serum level of creatine kinase (CK)
Delayed onset muscle pain 72 hours after the session Assessed by visual numerical scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain
Muscle fatigue 6 minutes after the session Assessed through the serum lactate level
Peripheral muscle strength up to 40 minutes after the session Assessed by dynamometry