Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432426
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-09
Brief Title:
Virtual Exercise on Elderly Breast Cancer Survivors
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
The Effect of Virtual Exercise on Elderly Breast Cancer Survivors on Functionality Muscular Strength and Quality of Life Effecto-B
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None