Authors
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Universidade Federal do Paraná -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2020
INTERVENTION: Functional electrostimulation Other The intervention (training) consists of two protocols: blood flow restriction and functional electrostimulation. Combined Group: The two techniques were applied to 9 individuals (right thigh + left thigh = N‐18), totaling 16 training sessions over 8 weeks. Individual Group: Applied only functional electro‐stimulation in 7 individuals (right thigh + left thigh ‐ N‐14), totaling 16 training sessions over 8 weeks. The intervention (training) consists of two protocols: blood flow restriction and functional electrostimulation. INTERVENTION DESCRIPTION: Blood flow restriction (BFR): The BFR was applied using a sphygmomanometer (25 cm wide x 92 cm long) placed around the thigh immediately below the inguinal crease. The BFR pressure for the training of each participant in the FES + BFR group was sufficient to interrupt the auscultatory pulse from tibial artery, as was measured by a vascular Doppler device (DV‐600, Martec, Ribeirão Preto, São Paulo). The training pressure was established to be 50% of the pressure obtained in the test, which has been shown to be effective in producing increases in thigh muscle mass (LAURENTINO et al., 2012). The average training pressure was 65.2 ± 7 mmHg. The pressure of the sphygmomanometer was maintained throughout the protocol of each session, including the intervals between series. The total time under pressure was approximately 15 minutes. No reported adverse reactions (e.g., dizziness or headache) were reported. Functional electrostimulation protocol (FES) Functional electro‐stimulation (FES) was applied with the participants sitting in their own wheelchairs, with their hips and knees flexed at approximately 80° and 30°, respectively. Successive contractions were evoked unilaterally thro CONDITION: C10.228. 854.763 Nerve and spinal cord injuries Spinal cord injuries. ; Nerve and spinal cord injuries SECONDARY OUTCOME: 1‐ Outcome secondary expected: ; Expected that muscle thickness will return to baseline after a detraining period (3 weeks after last trainnig session), mensured by ultrasound technique. 1‐ Outcome: ; Muscle thickness reduced to baseline after the detraining period, by ultrasound technique. 2‐ Outcome secondary expected: ; Expected edema will return to baseline after a detraining period (3 weeks after last trainnig session), mensured by echo intensity technique. 2‐ Outcome: ; Edema reduced to baseline after the detraining period (3 weeks after last trainnig session), mensured by echo intensity technique. Information after trial completion: ; ; ; ; INCLUSION CRITERIA: Men volunteers with complete spinal cord injury (ASIA A) and eligible for quadriceps responsiveness. PRIMARY OUTCOME: 1‐ Expected primary outcome:; Chronic increases in muscle mass measurement in the combined training group are expected to be significantly higher than the measurements in the individual group. It will be verified by the ultrasound technique, during the period of 8 weeks. 1‐ Primary outcome found:; Chronic increases in muscle mass measurements (11.7% = 2.67cm) in the combined training group significantly higher than the measurements in the individual group (non‐significant values), using the ultrasound technique, during the 8‐week period. 2‐ Expected primary outcome:; It is expected to find sharp increases in the measurement of muscle mass in the combined training group, significantly higher than the measurements in the individual group. It will be checked by ultrasound technique, before exercise and 5 minutes after the first training session. 2‐ Primary outcome found:; Acute increases in muscle mass measurements (19.7% = 2.79cm) in the combined training group are significantly higher than the values of the individual group (7.6% = 2.68cm), using the ultrasound technique, assessed before exercise and 5 minutes after the first training session. 3‐ Expected primary outcome:; It is expected to find sharp increases in the measure of edema in the combined training group significantly higher than the measures in the individual group. It will be checked by the echo intensity technique, before exercise and 5 minutes after the first training session. 3‐ Primary outcome found:; Acute increases in edema measurements (34.8% = 15 arbitrary units) in the combined training group are significantly higher than the values of the individual group (10.5% = 4 arbitrary units), using the echo intensity technique, assessed before the exercise and 5 minutes after the first training session. 4‐ Expected primary outcome:; It is expected to find chronic increases in the measure of edema in the combined training group, significantly higher than the measures of the individual group. It will be verified by the echo intensity technique, during the period of 8 weeks. 4‐ Primary outcome found:; Chronic increases in edema measurements (5.1% = 2 arbitrary units) in the combined training group are not significantly higher than the values of the individual group (non‐significant values). Checked by the echo intensity technique, over a period of 8 weeks. ; Muscle atrophy is one of the most evident consequences of spinal cord injuries (SCI), as a result of chronic immobility. The detrimental effects of SCI on large skeletal muscle groups may lead to secondary effects such as glucose intolerance, increased risk of metabolic syndrome and type 2 diabetes mellitus. Blood flow restriction (BFR) training has been proposed as an effective method to induce hypertrophy using low training loads, with little or no muscle damage. This study aimed to investigate the acute and chronic effects of low‐intensity functional electrical stimulation (FES) combined with blood flow restriction (BFR) on muscles affected by spinal cord injury. The acute effects of one bout of FES with (FES+BFR group) and without BFR (FES group) on muscle thickness (MT) and edema formation were compared. The chronic effects on MT and edema following 8‐weeks of twice weekly training with and without BFR were also compared. The FES+BFR group showed MT and edema increases compared to the FES only group (p<0,05). The FES+BFR group showed a chronic MT increase after 4 weeks of training (p<0.05), with no further MT increases from the 4th to the 8th week (p>0,05). Following 3 week of detraining, MT decreased to baseline values. No MT changes were observed in the FES group throughout the 8 weeks (p>0.05). This current study showed that 8 weeks of low‐intensity FES training combined with BFR induces MT increases on the paralyzed skeletal muscles of spinal cord‐injured men. The acute effects suggest that functional electrical stimulation induces a greater metabolites accumulation and edema, when combined with BFR. The chronic effects suggest that early increases in MT can be attributed to edema, whereas after the 4th week the increased MT can be interpreted predominantly as muscle hypertrophy.
Epistemonikos ID: 742133961ee2cc00c6dbbeb84cef7540471a3c79
First added on: Aug 24, 2024