Exercises Using Virtual Reality on Cancer Patients

Breast Cancer Female Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058936
• Other study ID #: H-2023-366
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: University of Hail
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	University of Hail	Hail

Sponsors (1)

Lead Sponsor	Collaborator
University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip strength	will be measured by Pablo system for the affected and unaffected upper limbs	at baseline
Primary	handgrip strength	will be measured by Pablo system for the affected and unaffected upper limbs	after the end of the treatment (after 8 weeks)
Primary	wrist joint active range of motion (ROM)	flexion and extension active ROM of the wrist joints will be assessed using Pablo system	baseline
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)