Breast Cancer Clinical Trial
Official title:
The Effect of Virtual Exercise on Elderly Breast Cancer Survivors on Functionality, Muscular Strength, and Quality of Life Effecto-B):
NCT number | NCT06432426 |
Other study ID # | 38330628 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2023 |
Est. completion date | July 1, 2025 |
Breast cancer (BC) is the most common neoplasia. Frequent for women and half of the new cases occur in people over 65 years of age. The treatment of BC generates adverse effects that deteriorate the physical functionality, muscle strength and quality of life of the survivors. This is more noticeable in elderly BC survivors. Physical exercise improves some adverse effects of BC, but few studies have focused on physical functionality, especially in older people. The elderly population reports the lowest adherence and lower level of physical activity. It is relevant to explore innovative and specific proposals for physical exercise for elderly survivors of BC. One solution may be virtual reality game-based exercise, which has been shown in healthy older people to significantly improve physical functionality and adherence compared to traditional physical exercise. The objective of our study is to estimate the feasibility and effect of a virtual reality-based exercise program on the functionality, muscle strength, and quality of life of older BC survivors, compared to a group undergoing traditional physical exercise.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - Women between 60 and 80 years old. - Diagnosis of primary breast carcinoma. - Treated with at least two of the following treatments: surgery, radiotherapy, chemotherapy, hormone therapy, biological therapy. - Minimum of 2 years and a maximum of 10 years after finishing treatments (surgery, chemotherapy, and radiotherapy). - Being able to walk at least 4 meters independently or with a cane as assistive technology Exclusion Criteria: - Stage IV breast cancer. - Previous cancer treatment for any type of cancer other than breast cancer (chemotherapy, radiotherapy, or endocrine therapy). - Cognitive impairment measured by the abbreviated Mini-Mental State Examination with a score < 13 points. - Medical contraindication to perform physical exercise. - Self-reported of physical activity equivalent to the recent American College of Sports Medicine Exercise Guidelines for Cancer Patients and Survivors (150 min/week of moderate aerobic exercise and strength exercise twice a week). - Body mass index < 18.5 kg/m2 or > 40 kg/m2. |
Country | Name | City | State |
---|---|---|---|
Chile | Complejo Asistencial Dr. Sótero del Río | Santiago | Puente Alto |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the functionality | Functionality will be measured by the Short Physical Performance Battery (SPPB). This battery is specific for older individuals and assess balance, walking speed, and lower extremity strength/endurance. It is a tool with moderate to excellent validity and excellent test-retest reliability (ICC=0.91). | Baseline, week 9 and week 13 | |
Secondary | Change in upper limb muscle strength | Upper body muscle strength will be assessed by manual grip strength measured with a hydraulic dynamometer (Jamar© hydraulic hand dynamometer) in kilograms. It is considered the gold standard for quantitative and objective evaluation of isometric hand and forearm muscle strength. | Baseline, week 9 and week 13 | |
Secondary | Change in lower limb muscle strength | Lower body muscle strength will be measured using the 30-second Chair Stand Test. It has excellent validity and reliability in older adults. It is measured in the number of repetitions. The number of times the person can stand up from the chair in 30 seconds is recorded. | Baseline, week 9 and week 13 | |
Secondary | Change in the quality of life score | Quality if life will be assessed with the QLQ C-30 questionnaire and the specific module QLQ-ELD14. The questionnaire could be self-administered and is validated to assess health-related quality of life in breast cancer patients. It has been validated in Spanish and in the Chilean population. Better quality of life is defined by a higher score (0-100) for global health status or overall quality of life. | Baseline, week 9 and week 13 | |
Secondary | Feasibility assesment | It will be measured by the recruitment rate (>50%), retention rate (>80%), adherence rate (75% of total sessions >14 sessions), and the incidence of adverse effects. The measurements will be reported together as feasibility | Baseline, week 1-9 and week 13 |
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