Breast Cancer Female
Conditions
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.
Interventions
OTHERexercises 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
Sponsors
University of Hail
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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)
Intervention model description
a randomized controlled trial with 2 arms parallel design
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | at baseline | will be measured by Pablo system for the affected and unaffected upper limbs |
| handgrip strength | after the end of the treatment (after 8 weeks) | will be measured by Pablo system for the affected and unaffected upper limbs |
| wrist joint active range of motion (ROM) | baseline | flexion and extension active ROM of the wrist joints will be assessed using Pablo system |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
Saudi Arabia
Outcome results
None listed