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The research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the established inclusion criteria. With this study, it is pretend to demonstrate the benefits of a program of therapeutic exercise and functional recovery of motor control with ultrasound feedback for the improvement of the functional capacity of the women eligible to participate in the study, as well as a positive impact on the quality of life of the patients other than their survival. The effect of the Overcome program will be compared with the usual treatment in this type of pathology. To do this, a pre-intervention evaluation and another at the end of the evaluation of the variables to be measured, such as functional capacity, will be carried out. In addition other evaluation will be carried out, after 6 months to assess the long-term effects.
In addition to the three main variables such as functional capacity and quality of life, another relationship of secondary variables will be studied, such as physical state, body composition or pain threshold, among others. This study in its entirety will be carried out by the "Oncology Patient Support Unit - Take Care" in the hands of a multidisciplinary team, carrying out the intervention protocolized by physiotherapists and occupational therapists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overcome group | Experimental | Three-month multimodal program. Aerobic exercise will be combined with the use of TRAG (AlterG® Anti-Gravity Treadmill®), functional recovery of motor control with feedback ultrasound and occupational therapy. |
|
| Usual treatment | No Intervention | Usual medical treatment for the same period of time |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overcome | Other | Multimodal program individualized and supervised 12 weeks duration (three months), with two sessions weekly face-to-face. This program will combine aerobic exercise in unloading through the use of the TRAG (AlterG® Anti-Gravity Treadmill®), functional recovery of motor control with feedback ultrasound and occupational therapy. Physical activity will be measured in parallel with the test. Likewise, the patients will be monitored by means of a heart rate sensor. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity | 6-minute walking test | Participants will be followed over 14 weeks |
| Quality of life (QLQ) | QLQ-C30 (Quality of Life of Cancer Patients) by the "European organization for reseach and treatment of cáncer quality life" (EORTC). This scale has 30 items, divided into a global health scale, 5 function subscales and 9 items/symptom scales. The scoring is obtained from through an Excel template. | Participants will be followed over 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| hand strength | Hand dynamometry, for which a digital dynamometer (TKK) 5101 Grip-D; Takey, Tokyo, Japan) | Participants will be followed over 14 weeks |
| Lower limb strength | sit-up text |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Lozano-Lozano, Dr | Contact | +34958249590 | mlozano@ugr.es | |
| Mario Lozano-Lozano | Contact | +34958249590 | mlozano@ugr.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences | Recruiting | Granada | 18016 | Spain |
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| Participants will be followed over 14 weeks |
| Body composition | Height will be measured (cm). Weight (kg), body mass index, skeletal muscle mass, and body fat percentage will be obtained using bioelectrical impedance analysis (InBody 720; Biospace, Seoul, South Korea) | Participants will be followed over 14 weeks |
| Muscle architecture of multifidus muscle | Muscle ultrasound and quantitative elastosonography will be performed of the multifidus muscle. We will obtain information in real time on the parameters related to the structural organization of the tissues (normal or abnormal elasticity) with respect to the adjacent tissue. of the multifidus muscle. | Participants will be followed over 14 weeks |
| Pain threshold on pressure, by algometry | Electronic algometer (Somedic AB, Farsta, Sweden) | Participants will be followed over 14 weeks |
| Anxiety and depression | "Hospital Anxiety and Depression Scale" (HADS). Composed of two subscales: Depression and Anxiety, each with seven items. The score of each subscale can vary between 0 and 21, since each item presents four response options, ranging from absence/minimal presence = 0, to maximum presence = 3. | Participants will be followed over 14 weeks |
| Opioid consumption and pain | By the scale"Brief Pain Inventory-SF". This questionnaire consists of 15 items of which only two subscales are scored organized into mean pain intensity (items 3-6) and mean pain interference (items 9A-9G), the rest of the items do not score. | Participants will be followed over 14 weeks |
| Specific quality of life of the patient with bone metastasis | QLQ-BM22 (quality of life questionnaire for bone metastases) by the "European organization for reseach and treatment of cáncer quality life" (EORTC). This questionnaire consists of 22 questions, which represent eight sections on symptom scales: five identify the painful sites, and three describe the characteristics of the pain; 14 headings represent functional scales: eight, of functional interferences, and six, refer to psychosocial aspects. | Participants will be followed over 14 weeks |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D013125 | Spinal Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013122 | Spinal Diseases |
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