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

NCT ID: NCT07068347

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2026-06-01

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

VR + lifestyle modification

Group Type: EXPERIMENTAL

VR + lifestyle modification

Intervention Type: COMBINATION_PRODUCT

VR + lifestyle modification (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.In lifestyle modification walking at home for 30 min in 3-5 days /week. Dietry habits will be given according to American Institute for cancer Research.

In sleep habits Recommended Sleep Hours 7-9 hours per night,Establish a Consistent Sleep Schedule,Create a Comfortable Sleep Environment,Limit Screen Time Before Bed,Engage in Relaxation Techniques,Limit Caffeine and Alcohol Intake,Manage Nighttime Discomfort,Maintain a Pre-Sleep Routine,Address Emotional Health,Avoid Daytime Naps.Deep breathing exercise for stress management

VR only

Group Type: ACTIVE_COMPARATOR

VR only

Intervention Type: COMBINATION_PRODUCT

VR only (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.

Conventional physical therapy + lifestyle modification

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy + lifestyle modification

Intervention Type: COMBINATION_PRODUCT

Conventional physical therapy + lifestyle modification In Conventional physical therapy(Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated)

Conventional physical therapy only

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy only

Intervention Type: COMBINATION_PRODUCT

Conventional physical therapy only((Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated) ,Trunk lateral flexion with arms in 90 degrees abduction in standing position,Theraband (flexion-extension-abduction, adduction and internal-external rotation),Muscles of upper limb strengthening ,Mobilization for passive glenohumeral joint ,Tissue massage for scars.

Interventions

VR + lifestyle modification

VR + lifestyle modification (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.In lifestyle modification walking at home for 30 min in 3-5 days /week. Dietry habits will be given according to American Institute for cancer Research.

In sleep habits Recommended Sleep Hours 7-9 hours per night,Establish a Consistent Sleep Schedule,Create a Comfortable Sleep Environment,Limit Screen Time Before Bed,Engage in Relaxation Techniques,Limit Caffeine and Alcohol Intake,Manage Nighttime Discomfort,Maintain a Pre-Sleep Routine,Address Emotional Health,Avoid Daytime Naps.Deep breathing exercise for stress management

Intervention Type: COMBINATION_PRODUCT

VR only

VR only (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.

Intervention Type: COMBINATION_PRODUCT

Conventional physical therapy + lifestyle modification

Conventional physical therapy + lifestyle modification In Conventional physical therapy(Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated)

Intervention Type: COMBINATION_PRODUCT

Conventional physical therapy only

Conventional physical therapy only((Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated) ,Trunk lateral flexion with arms in 90 degrees abduction in standing position,Theraband (flexion-extension-abduction, adduction and internal-external rotation),Muscles of upper limb strengthening ,Mobilization for passive glenohumeral joint ,Tissue massage for scars.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

District Head Quarters Hospital

Rawalpindi, Punjab Province, Pakistan

Holy Family Hospital

Rawalpindi, Punjab Province, Pakistan

Kinifit Physiotherapy Center

Islamabad, , Pakistan

Countries

Pakistan

Other Identifiers

PhDRSW/Batch-Fall23/2223

Identifier Type: -

Identifier Source: org_study_id