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Exercises Using Virtual Reality on Cancer Patients

Primary Purpose

Breast Cancer Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
exercises using virtual reality technology
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hail

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

virtual reality

regular exercises

Arm Description

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

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

Outcomes

Primary Outcome Measures

Handgrip strength
will be measured by Pablo system for the affected and unaffected upper limbs
handgrip strength
will be measured by Pablo system for the affected and unaffected upper limbs
wrist joint active range of motion (ROM)
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
wrist joint active ROM
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
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.
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.
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.
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.
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
University of Hail
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1. Study Identification

Unique Protocol Identification Number
NCT06058936
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomized controlled trial with 2 arms parallel design
Masking
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)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
virtual reality
Arm Type
Experimental
Arm Description
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
Arm Title
regular exercises
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
exercises using virtual reality technology
Other Intervention Name(s)
Pablo©Handle training
Intervention Description
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
Primary Outcome Measure Information:
Title
Handgrip strength
Description
will be measured by Pablo system for the affected and unaffected upper limbs
Time Frame
at baseline
Title
handgrip strength
Description
will be measured by Pablo system for the affected and unaffected upper limbs
Time Frame
after the end of the treatment (after 8 weeks)
Title
wrist joint active range of motion (ROM)
Description
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Time Frame
baseline
Title
wrist joint active ROM
Description
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Time Frame
after the end of the treatment (after 8 weeks)
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
at baseline
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
after the end of the treatment (after 8 weeks)
Title
Fatigue by Multidimensional Fatigue Inventory
Description
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.
Time Frame
at baseline
Title
Fatigue by Multidimensional Fatigue Inventory
Description
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.
Time Frame
after the end of the treatment (after 8 weeks)
Title
Anxiety by The State Anxiety Inventory (SAI)
Description
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
Time Frame
at baseline
Title
Anxiety by The State Anxiety Inventory (SAI)
Description
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
Time Frame
after the end of the treatment (after 8 weeks)
Title
Pain using Numerical Rating Scale (NRS)
Description
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
Time Frame
at baseline
Title
Pain using Numerical Rating Scale (NRS)
Description
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
Time Frame
after the end of the treatment (after 8 weeks)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
due to the nature of the study population (breast cancer). only females who suffered breast cancer and underwent surgical treatment will be included
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Hail
City
Hail
ZIP/Postal Code
3994
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisham Hussein
Email
hm.hussein@uoh.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercises Using Virtual Reality on Cancer Patients

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