Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases
NCT ID: NCT05244382
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2022-02-07
2025-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Overcome group
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.
Overcome
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.
Usual treatment
Usual medical treatment for the same period of time
No interventions assigned to this group
Interventions
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Overcome
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.
Eligibility Criteria
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Inclusion Criteria
2. The bone metastasis is located only at bone level (low neurological risk).
3. Not having exercised regular physical during last 3 months.
4. ECOG (Eastern Cooperative Oncology Group) ≤ 1.
5. \> 4 weeks from a major surgery and full recovery.
Exclusion Criteria
2. Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
3. Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
4. Have started or changed treatment hormonal during the last 3 months at recruitment.
5. Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
6. Present brain metastasis.
7. Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations \<160/90 regardless of whether a regimen of antihypertensive therapy or not).
8. Having had a serious cardiovascular event recently (in the last 12 months), including, but not limited to ischemic attack transient (TIA), cerebrovascular accident (CVA) or myocardial infarction (MI).
9. Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.
18 Years
FEMALE
No
Sponsors
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Universidad de Granada
OTHER
Responsible Party
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Mario Lozano-Lozano
Principal investigator
Locations
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Faculty of Health Sciences
Granada, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Overcome project
Identifier Type: -
Identifier Source: org_study_id