Exercises Using Virtual Reality on Cancer Patients

NCT ID: NCT06058936

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-07-30

Brief Summary

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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

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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

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized controlled trial with 2 arms parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Concealed allocation will be performed by a researcher who will not be involved in the treatment of assessment. Permuted blocks will be used to ensure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the data analyzer will be blindfolded (double-blinded)

Study Groups

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virtual reality

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

Group Type EXPERIMENTAL

exercises using virtual reality technology

Intervention Type OTHER

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

regular exercises

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

Group Type ACTIVE_COMPARATOR

exercises using virtual reality technology

Intervention Type OTHER

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

Interventions

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exercises using virtual reality technology

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

Intervention Type OTHER

Other Intervention Names

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Pablo©Handle training

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Hail

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelmoniem Ibrahim

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Hail

Hail, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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H-2023-366

Identifier Type: -

Identifier Source: org_study_id

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