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Completed

NCT Number: NCT06058936

Exercises Using Virtual Reality on Cancer 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

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Key information

Conditions

Breast Cancer Female

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Hail

Ha'il, 3994, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercises using virtual reality technology

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

Other names: Pablo©Handle training

Primary outcomes

  1. Handgrip strength

    Time frame: at baseline

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

  2. handgrip strength

    Time frame: 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)

    Time frame: baseline

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

  4. wrist joint active ROM

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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