Breast CancerNCT06432426
Virtual Exercise on Elderly Breast Cancer Survivors
A study testing Virtual reality training group and Standard physical exercise group in people with Breast Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Virtual reality training group and Standard physical exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Complejo Asistencial Dr. Sótero del Río
Santiago, Puente Alto
Karol Ramírez-Parada
Scarlet Muñoz
About this study
Official title: The Effect of Virtual Exercise on Elderly Breast Cancer Survivors on Functionality, Muscular Strength, and Quality of Life Effecto-B):
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.
Read the 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
- Being tested
- Virtual reality training group, Standard physical exercise group
- Keywords
- breast neoplasm, elderly, physical exercise, virtual reality
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality training groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Standard physical exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, week 9 and week 13
Secondary outcomes (4)
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.
Measured: Baseline, week 9 and week 13
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.
Measured: 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.
Measured: 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
Measured: Baseline, week 1-9 and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Oct 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karol Ramírez-Parada, PT, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432426
- Sponsor's protocol ID
- 38330628
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Exercise on Elderly Breast Cancer Survivors on Functionality, Muscular Strength, and Quality of Life Effecto-B):
- ClinicalTrials.gov ID
- NCT06432426
- Acronym / sponsor ID
- 38330628
- Conditions
- Breast Cancer
- Keywords
- breast neoplasm, elderly, physical exercise, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training Group | Experimental | Behavioral: Virtual reality training groupParticipants 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. |
| Standard physical exercise Group | Active comparator | Behavioral: Standard physical exercise groupParticipants will undergo a standardized physical exercise program based on a validated protocol designed for elderly breast cancer survivors |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality training groupParticipants 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. | Behavioural | Virtual Reality Training Group |
| Standard physical exercise groupParticipants 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. | Behavioural | Standard physical exercise Group |
Primary outcome
Change in the functionality
Time frame: Baseline, week 9 and week 13
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).
4 secondary outcomes
Change in upper limb muscle strength
Time frame: Baseline, week 9 and week 13
Change in lower limb muscle strength
Time frame: Baseline, week 9 and week 13
Change in the quality of life score
Time frame: Baseline, week 9 and week 13
Feasibility assesment
Time frame: Baseline, week 1-9 and week 13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karol Ramírez-Parada, PT principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality training group and Standard physical exercise group in people with Breast Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karol Ramírez-Parada, PT (22 3541168, kramirezp@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the functionality (time frame: Baseline, week 9 and week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.