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A prospective randomized clinical trial of patients undergoing bariatric surgery.
Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.
Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENS with training | Experimental | Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively |
|
| Specific training | Active Comparator | Patients undergoing specific training during 12 weeks postoperatively |
|
| No intervention | No Intervention | No specific treatment was assigned to these patients postoperatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PENS | Device | The participants underwent one 30-min session every week for 12 consecutive weeks. PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm. PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain. PENS was delivered simultaneously in both pectoral muscles. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction degree. 7-points Likert scale was used for the quantification. | The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment. | 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Ruiz-Tovar, MD, PhD | Hospital General Elche | Principal Investigator |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Specific training | Other | Patients underwent specific training exercises to improve pectoral fitness. |
|