Exercises Using Virtual Reality on Cancer Patients

NCT06058936 | Completed

• 1 other identifier: H-2023-366
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (12)

• Handgrip strength

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

  at baseline

• handgrip strength

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

  after the end of the treatment (after 8 weeks)

• wrist joint active range of motion (ROM)

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

  baseline

• 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)

• 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

• 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)

• 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

• 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)

• 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

• 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)

• 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

• 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)

Study Arms (2)

virtual reality

EXPERIMENTAL

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

regular exercises

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Pablo©Handle training

regular exercises; virtual reality

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: due to the nature of the study population (breast cancer). only females who suffered breast cancer and underwent surgical treatment will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

University of Hail

Hail, 3994, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: a randomized controlled trial with 2 arms parallel design

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 15, 2023
• Primary Completion: June 12, 2024
• Study Completion: July 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)