Comparison Of VR & CPT, With And Without Lifestyle Modification, On ULD In Breast Cancer Survivors

Superior University

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Combination Product: Conventional physical therapy + lifestyle modification; Combination Product: VR only; Combination Product: VR + lifestyle modification; Combination Product: Conventional physical therapy only

Study type: Interventional

Funder types: Other

Identifiers

NCT07068347

PhDRSW/Batch-Fall23/2223

Details and patient eligibility

About

The proposed study will compare the effect of an application of non-immersive virtual reality (VR) and conventional physical therapy (CPT) with and without lifestyle changes on upper limb dysfunction in breast cancer survivors, post-surgery. The purpose of this proposed RCT is to compare the effect of VR alone/in conjunction with lifestyle changes to that of CPT alone/in conjunction with lifestyle changes for the physical rehabilitation of female breast cancer survivors. Research will be conducted on 60 patients. This research employs parallel, randomized clinical trial design, which shall be conducted in NORI hospital, Shifa International Hospital and Kinifit physiotherapy in Islamabad/Rawalpindi over a period of 18 months. Thus, the type of sampling done in this study is purposive sampling.

Full description

Primary Objectives:

1. To compare the effects of immersive virtual reality and conventional physical therapy, with and without lifestyle modification, on upper limb functional disability in post-surgical breast cancer survivors.

   Secondary Objectives:

2. To assess the effects of immersive virtual reality compared to conventional physical therapy, with and without lifestyle modification, on improving pain, shoulder range of motion and muscle strength in post-surgical breast cancer survivors.

3. To determine the effects of immersive virtual reality compared to conventional physical therapy with and without lifestyle modification on quality of life and psychological wellbeing in post-surgical breast cancer survivors.

4. To evaluate self-reported adherence to the life style modification program among post-surgical breast cancer survivors.

Enrollment: 60 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female breast cancer survivors aged 30-60 years.
• Women with breast cancer who have undergone any type of breast cancer surgery (e.g., mastectomy, lumpectomy, or breast reconstruction), regardless of the specific surgical procedure will be included.
• Participants able to carry on upper limb and whole-body physical activity will be included.
• Participants able to use smart devices such as mobile phones and computers will be included.
• Patients obtaining a physician's clearance for fitness testing and exercise will be included.
• Patients having no physical limitations prohibiting exercise will be included.
• Patients diagnosed with grade 0-3 of breast cancer who had undergone surgery will be included.
• who were currently in the 2nd ~ 4th months after cancer surgery.
• Presence of upper limb dysfunction (e.g., pain, reduced range of motion and weakness).

Exclusion criteria

• Subjects suffering from active malignant tumors or bilateral breast cancer.
• Participants disabling physical or psychological ailments not allowing them to participate in the intervention .
• Patients who had lymphedema will be excluded.
• Participants with visual disorders that interfered with a video game- based exercise.
• Subjects with cognitive disorders, mental disorders, or cooperation issues will be excluded.Subjects with vascular or cardiopulmonary disorders.
• Subjects with previous breast cancer surgery on the present or contralateral side.
• Participants having upper extremity ROM limitation before the surgery will be excluded.
• Participants with presence of pace-maker, infection, open wounds, or wound drains will be excluded.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

VR + lifestyle modification

Experimental group

Treatment:

Combination Product: VR + lifestyle modification

VR only

Active Comparator group

Treatment:

Combination Product: VR only

Conventional physical therapy + lifestyle modification

Active Comparator group

Treatment:

Combination Product: Conventional physical therapy + lifestyle modification

Conventional physical therapy only

Active Comparator group

Treatment:

Combination Product: Conventional physical therapy only