Breast Cancer FemaleNCT06058936
Exercises Using Virtual Reality on Cancer Patients
A study testing exercises using virtual reality technology in people with Breast Cancer Female, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- exercises using virtual reality technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Sep 2023to 30 Jul 2024
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer female patients
- Age ≥40 years
- All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
- Having to undergo primary treatment with surgery, chemotherapy, and/or radiotherapy based on the patient's need
Who cannot join
- Severe anemia (Hb ≤ 8 g/dL)
- Uncontrolled hypertension, diabetes
- severe infection, neurologic or muscular diseases prohibiting physical activity
- severe heart disease or myocardial infarction during the last six months, and a severe chronic obstructive pulmonary disease
- uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
- Contraindications given by the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Virtual Reality Using Pablo Game Training Program on Upper Extremity Muscle Strength, Pain, Function and Activity of Daily Living in Post-operative Breast Cancer Female Patients.
in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment
Read the detailed description
in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment.
A virtual reality (VR) environment is created by combining computer systems and sensor technology with the use of three-dimensional graphics and enabling users to experience a more real, immersive experience by utilizing their various senses (vision, hearing, touch, etc.) through the use of the computer and sensor technologies and it is characterized by immersion, imagination, and interaction 2 groups will be selected randomly to receive experimental and control intervention for 1 month and outcomes will be collected before and after treatment.
- Conditions
- Breast Cancer Female
- Being tested
- exercises using virtual reality technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercises using virtual reality technologyOther
Also called Pablo©Handle training
this is a one-dimensional therapy game using (Handle/ or Multiball) five games are available for the Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Applehunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | The patients in this group are under exercise training and pneumatic pressure followed by Pablo©Handle training for 45 minutes per week for 8 week
-Pablo©Handle training One-dimensional therapy games using five games are available for Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Apple hunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week Receives: Other: exercises using virtual reality technology |
| regular exercises | Active comparator | The patients in this group will receive exercise training and pneumatic pressure only for 30 min3 times per week for 8 week
* Exercise training will be done by the following exercise for 15 min3 times per week for 8 week
* Intermittent Compression Therapy Parameters: using the (Care Pump expert 8)
* Pressure. 60 mmHg, Direction. Distal to proximal, Speed 4 to 5, for 15 min /3 times per week for 8 week Receives: Other: exercises using virtual reality technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
will be measured by Pablo system for the affected and unaffected upper limbs
Measured: at baseline
handgrip strength
will be measured by Pablo system for the affected and unaffected upper limbs
Measured: after the end of the treatment (after 8 weeks)
wrist joint active range of motion (ROM)
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Measured: baseline
wrist joint active ROM
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Measured: after the end of the treatment (after 8 weeks)
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH is a 30-item questionnaire. Each item is scored on a 1 (no difficulty) to 5 (unable) scale. The total score may range from 0 to 100 points. High scores indicate a high level of disability.
Measured: at baseline
Disabilities of the Arm, Shoulder and Hand (DASH)
DASH is a 30-item questionnaire. Each item is scored on a 1 (no difficulty) to 5 (unable) scale. The total score may range from 0 to 100 points. High scores indicate a high level of disability.
Measured: after the end of the treatment (after 8 weeks)
Fatigue by Multidimensional Fatigue Inventory
The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
Measured: at baseline
Fatigue by Multidimensional Fatigue Inventory
The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
Measured: after the end of the treatment (after 8 weeks)
Anxiety by The State Anxiety Inventory (SAI)
SAI is a valid and commonly used measure for anxiety The SAI includes 20 items; each item is scored on a 4-point Likert scale The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety
Measured: at baseline
Anxiety by The State Anxiety Inventory (SAI)
SAI is a valid and commonly used measure for anxiety The SAI includes 20 items; each item is scored on a 4-point Likert scale The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety
Measured: after the end of the treatment (after 8 weeks)
Pain using Numerical Rating Scale (NRS)
this scale is valid and reliable measure of pain intensity. the patient is asked to rate pain intensity be choosing a number from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain ever
Measured: at baseline
Pain using Numerical Rating Scale (NRS)
this scale is valid and reliable measure of pain intensity. the patient is asked to rate pain intensity be choosing a number from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain ever
Measured: after the end of the treatment (after 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Sep 2023
- Primary completion12 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Model description
- a randomized controlled trial with 2 arms parallel design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelmoniem Ibrahim, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058936
- Sponsor's protocol ID
- H-2023-366
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Using Pablo Game Training Program on Upper Extremity Muscle Strength, Pain, Function and Activity of Daily Living in Post-operative Breast Cancer Female Patients.
- ClinicalTrials.gov ID
- NCT06058936
- Acronym / sponsor ID
- H-2023-366
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 28 Sep 2023 (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.
in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment
Detailed description
in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment.
A virtual reality (VR) environment is created by combining computer systems and sensor technology with the use of three-dimensional graphics and enabling users to experience a more real, immersive experience by utilizing their various senses (vision, hearing, touch, etc.) through the use of the computer and sensor technologies and it is characterized by immersion, imagination, and interaction 2 groups will be selected randomly to receive experimental and control intervention for 1 month and outcomes will be collected before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a randomized controlled trial with 2 arms parallel design
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Other: exercises using virtual reality technologyThe patients in this group are under exercise training and pneumatic pressure followed by Pablo©Handle training for 45 minutes per week for 8 week -Pablo©Handle training One-dimensional therapy games using five games are available for Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Apple hunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week |
| regular exercises | Active comparator | Other: exercises using virtual reality technologyThe patients in this group will receive exercise training and pneumatic pressure only for 30 min3 times per week for 8 week * Exercise training will be done by the following exercise for 15 min3 times per week for 8 week * Intermittent Compression Therapy Parameters: using the (Care Pump expert 8) * Pressure. 60 mmHg, Direction. Distal to proximal, Speed 4 to 5, for 15 min /3 times per week for 8 week |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer female patients
- Age ≥40 years
- All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
- Having to undergo primary treatment with surgery, chemotherapy, and/or radiotherapy based on the patient's need
Key exclusion criteria (6 listed)
- Severe anemia (Hb ≤ 8 g/dL)
- Uncontrolled hypertension, diabetes
- severe infection, neurologic or muscular diseases prohibiting physical activity
- severe heart disease or myocardial infarction during the last six months, and a severe chronic obstructive pulmonary disease
- uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
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 |
|---|---|---|
| exercises using virtual reality technologyAlso: Pablo©Handle trainingthis is a one-dimensional therapy game using (Handle/ or Multiball) five games are available for the Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Applehunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week | Other | regular exercises, virtual reality |
Primary outcome
Handgrip strength
Time frame: at baseline
will be measured by Pablo system for the affected and unaffected upper limbs
handgrip strength
Time frame: after the end of the treatment (after 8 weeks)
will be measured by Pablo system for the affected and unaffected upper limbs
wrist joint active range of motion (ROM)
Time frame: baseline
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
wrist joint active ROM
Time frame: after the end of the treatment (after 8 weeks)
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: at baseline
DASH is a 30-item questionnaire. Each item is scored on a 1 (no difficulty) to 5 (unable) scale. The total score may range from 0 to 100 points. High scores indicate a high level of disability.
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: after the end of the treatment (after 8 weeks)
DASH is a 30-item questionnaire. Each item is scored on a 1 (no difficulty) to 5 (unable) scale. The total score may range from 0 to 100 points. High scores indicate a high level of disability.
Fatigue by Multidimensional Fatigue Inventory
Time frame: at baseline
The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
Fatigue by Multidimensional Fatigue Inventory
Time frame: after the end of the treatment (after 8 weeks)
The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
Anxiety by The State Anxiety Inventory (SAI)
Time frame: at baseline
SAI is a valid and commonly used measure for anxiety The SAI includes 20 items; each item is scored on a 4-point Likert scale The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety
Anxiety by The State Anxiety Inventory (SAI)
Time frame: after the end of the treatment (after 8 weeks)
SAI is a valid and commonly used measure for anxiety The SAI includes 20 items; each item is scored on a 4-point Likert scale The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety
Pain using Numerical Rating Scale (NRS)
Time frame: at baseline
this scale is valid and reliable measure of pain intensity. the patient is asked to rate pain intensity be choosing a number from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain ever
Pain using Numerical Rating Scale (NRS)
Time frame: after the end of the treatment (after 8 weeks)
this scale is valid and reliable measure of pain intensity. the patient is asked to rate pain intensity be choosing a number from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain ever
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises using virtual reality technology in people with Breast Cancer Female, run by University of Hail at 1 site in Saudi Arabia.
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 4 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength (time frame: at baseline). The study lists 12 primary outcomes in all. 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 7 Jan 2025.