Virtual Exercise on Elderly Breast Cancer Survivors

NCT ID: NCT06432426

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-07-01

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Training Group

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.

Group Type: EXPERIMENTAL

Virtual reality training group

Intervention Type: 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.

Standard physical exercise Group

Participants will undergo a standardized physical exercise program based on a validated protocol designed for elderly breast cancer survivors

Group Type: ACTIVE_COMPARATOR

Standard physical exercise group

Intervention Type: 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.

Interventions

Virtual reality training group

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.

Intervention Type: BEHAVIORAL

Standard physical exercise group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karol Ramírez-Parada, PT

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Complejo Asistencial Dr. Sótero del Río

Santiago, Puente Alto, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Karol Ramírez-Parada, PT

Role: CONTACT

kramirezp@uc.cl

22 3541168

Facility Contacts

Karol Ramírez-Parada

Role: primary

Other Identifiers

38330628

Identifier Type: -

Identifier Source: org_study_id