Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases

NCT05244382 | Unknown

• 1 other identifier: Overcome project
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasm Female; Neoplasm Metastasis; Spinal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• hand strength

  Participants will be followed over 14 weeks

• Lower limb strength

  Participants will be followed over 14 weeks

• Body composition

  Participants will be followed over 14 weeks

• Muscle architecture of multifidus muscle

  Participants will be followed over 14 weeks

• Pain threshold on pressure, by algometry

  Participants will be followed over 14 weeks

Study Arms (2)

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.

Other: Overcome

Usual treatment

NO INTERVENTION

Usual medical treatment for the same period of time

Interventions

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.

Overcome group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having breast cancer controlled primary and occurrence of one or more bone lesions (metastases osteoblastic) with location in the pelvis, lumbar spine and / or thoracic, attributable to breast cancer
• The bone metastasis is located only at bone level (low neurological risk).
• Not having exercised regular physical during last 3 months.
• ECOG (Eastern Cooperative Oncology Group) ≤ 1.
• \> 4 weeks from a major surgery and full recovery.

You may not qualify if:

• Present cardiac toxicity secondary to treatments with decreased LVEF (If the LVEF percentage falls ≥ 10 points with respect to baseline or LVEF is below 50%) or QT prolongation
• Present any other toxicity greater than grade 2 in related to the treatments you are receiving or received in advance.
• Have spinal cord involvement, epidural involvement or instrumentation due to disease metastatic. (Moderate-high neurological risk)
• Have started or changed treatment hormonal during the last 3 months at recruitment.
• Present any pathology that prevents participation in a physical exercise program (PARQ-YOU).
• Present brain metastasis.
• Present uncontrolled hypertension (during recruitment, ≥2 / 3 evaluations \<160/90 regardless of whether a regimen of antihypertensive therapy or not).
• 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).
• Present a psychiatric illness, which would prevent the patient from signing the informed consent or adhere to the study protocol.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences

Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Spinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Central Study Contacts

Mario Lozano-Lozano, Dr

CONTACT

+34958249590; mlozano@ugr.es

Mario Lozano-Lozano

CONTACT

+34958249590; mlozano@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 17, 2022
• Study Start: February 7, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

ES (1)