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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.
This is a randomized controlled study. It will be conducted at the Dr. Sotero del Río Assistance Complex, which receives Southeast Metropolitan Health Service patients. Participants: 60 women over 60yrs who completed their antineoplastic treatment at least two years ago will be recruited.
Functionality will be measured using the Short Physical Performance Battery (SPPB), which is specific for older individuals. Hydraulic Dynamometry (Jamar © hydraulic hand dynamometer) will evaluate isometric upper limb muscle strength. Quality of life shall be assessed using the EORTC QLQ C30 Quality of Life Questionnaire - with its EORTC QLQ-ELD14 module, validated in the Chilean population. Feasibility will be measured using recruitment rate (≥50%), retention rate (≥ 80%), adherence rate (75% of total sessions ≥14 sessions), and incidence of adverse events.
Candidates will be randomly assigned to either virtual reality or traditional exercise groups. Both training groups will involve supervised sessions twice a week for nine weeks. The traditional exercise group exercises will be for arms and legs, involving body weight and external weights. Meanwhile, the virtual reality group will follow a physical exercise protocol using the "Nintendo Wii Fit" console. After the 9th week, participants will be evaluated one month after completing the training program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Training Group | Experimental | Participants will undergo a postural balance rehabilitation program, utilizing a probed protocol for the elderly population with virtual reality via the Nintendo Wii Fit® and its peripheral Balance Board system. Supervised group sessions will be conducted twice a week for 9 weeks. |
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| Standard physical exercise Group | Active Comparator | Participants will undergo a standardized physical exercise program based on a validated protocol designed for elderly breast cancer survivors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality training group | Behavioral | Participants will be given virtual reality games on Nintendo Wii Fit® and its peripheral Balance Board system. This equipment offers safe and engaging training protocols. Additionally, it ensures physical exercise in the three planes of movement (sagittal, frontal, and transverse) and with three difficulty levels, thus providing a linear progressive demand. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karol Ramírez-Parada, PT | Contact | 22 3541168 | kramirezp@uc.cl |
| Name | Affiliation | Role |
|---|---|---|
| Karol Ramírez-Parada, PT | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Asistencial Dr. Sótero del Río | Recruiting | Santiago | Puente Alto | Chile |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Standard physical exercise group | Behavioral | Participants will be submitted to a standard physical exercise program based on the ACSM guidelines. Resistance training will involve exercises for arms and legs, using bodyweight self-loading and external weights. Balance exercises will include the three planes of movement. |
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| 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 |
| 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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |