Virtual Exercise on Elderly Breast Cancer Survivors

NCT06432426 | Recruiting DMC

• 1 other identifier: 38330628
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast neoplasm; elderly; physical exercise; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in upper limb muscle strength

  Baseline, week 9 and week 13

• Change in lower limb muscle strength

  Baseline, week 9 and week 13

• Change in the quality of life score

  Baseline, week 9 and week 13

• Feasibility assesment

  Baseline, week 1-9 and week 13

Study Arms (2)

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.

Behavioral: Virtual reality training group

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

Behavioral: Standard physical exercise group

Interventions

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.

Virtual Reality Training Group

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.

Standard physical exercise Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Complejo Asistencial Dr. Sótero del Río

Santiago, Puente Alto, Chile

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Karol Ramírez-Parada, PT

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karol Ramírez-Parada, PT

CONTACT

22 3541168; kramirezp@uc.cl

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: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 29, 2024
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CL (1)