Exercises Using Virtual Reality on Cancer Patients

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: exercises using virtual reality technology

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 3994
    • University of Hail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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; Other Names: Pablo©Handle training
Active Comparator: 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	Other: 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; Other Names: Pablo©Handle training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	will be measured by Pablo system for the affected and unaffected upper limbs	at baseline
handgrip strength	will be measured by Pablo system for the affected and unaffected upper limbs	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	baseline
wrist joint active ROM	flexion and extension active ROM of the wrist joints will be assessed using Pablo system	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.	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.	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.	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.	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	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	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	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	after the end of the treatment (after 8 weeks)

Collaborators and Investigators

• Sponsor: University of Hail

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: H-2023-366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No