Exercises Using Virtual Reality on Cancer Patients

• Sponsor: University of Hail (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06058936
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Other: exercises using virtual reality technology	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: a randomized controlled trial with 2 arms parallel designa randomized controlled trial with 2 arms parallel design
• Masking: Single (Outcomes Assessor)
• Masking Description: 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)
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Oct 15, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Handgrip strength [at baseline]

   will be measured by Pablo system for the affected and unaffected upper limbs

2. handgrip strength [after the end of the treatment (after 8 weeks)]

   will be measured by Pablo system for the affected and unaffected upper limbs

3. wrist joint active range of motion (ROM) [baseline]

   flexion and extension active ROM of the wrist joints will be assessed using Pablo system

4. wrist joint active ROM [after the end of the treatment (after 8 weeks)]

   flexion and extension active ROM of the wrist joints will be assessed using Pablo system

5. Disabilities of the Arm, Shoulder and Hand (DASH) [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.

6. Disabilities of the Arm, Shoulder and Hand (DASH) [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.

7. Fatigue by Multidimensional Fatigue Inventory [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.

8. Fatigue by Multidimensional Fatigue Inventory [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.

9. Anxiety by The State Anxiety Inventory (SAI) [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

10. Anxiety by The State Anxiety Inventory (SAI) [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

11. Pain using Numerical Rating Scale (NRS) [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

12. Pain using Numerical Rating Scale (NRS) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Hail	Hail		Saudi Arabia	3994

Sponsors and Collaborators

• University of Hail

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abdelmoniem Ibrahim, principal investigator, University of Hail
• ClinicalTrials.gov Identifier: NCT06058936
• Other Study ID Numbers: H-2023-366
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 28, 2023