Clinical trial NCT06058936: Exercises Using Virtual Reality on Cancer Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 54
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized controlled trial with 2 arms parallel design
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Handgrip strength
timeFrame: at baseline
measure: handgrip strength
timeFrame: after the end of the treatment (after 8 weeks)
measure: wrist joint active range of motion (ROM)
timeFrame: baseline
measure: wrist joint active ROM
timeFrame: after the end of the treatment (after 8 weeks)
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: at baseline
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: after the end of the treatment (after 8 weeks)
measure: Fatigue by Multidimensional Fatigue Inventory
timeFrame: at baseline
measure: Fatigue by Multidimensional Fatigue Inventory
timeFrame: after the end of the treatment (after 8 weeks)
measure: Anxiety by The State Anxiety Inventory (SAI)
timeFrame: at baseline
measure: Anxiety by The State Anxiety Inventory (SAI)
timeFrame: after the end of the treatment (after 8 weeks)
measure: Pain using Numerical Rating Scale (NRS)
timeFrame: at baseline
measure: Pain using Numerical Rating Scale (NRS)
timeFrame: after the end of the treatment (after 8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: University of Hail
Study officials:
References: