Effect of Exercise Mode in Breast Cancer-Related Lymphedema

NCT ID: NCT04724356

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-05-05

Brief Summary

Gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema. Therefore, the purpose of this work was to compare the effects of Xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with Breast cancer-related lymphedema.

Detailed Description

Breast cancer-related lymphedema is a common and debilitating side effect of cancer treatment. This study compared the effect of Xbox kinect rehabilitation and resistance exercises on breast cancer-related lymphedema volume and severity, as well as participant's physical function and quality of life. Women diagnosed with unilateral breast cancer related lymphedema were randomly divided into two groups: the kinect based rehabilitation group KBRG and resistance exercise group REG. woman in The KBRG received virtual reality therapy using Xbox Kinect-based games, the REG received resistance training in addition both groups received complex decongestive physiotherapy. The intervention was five sessions per week for 8 weeks. The outcome measures included limb volume, symptoms severity, physical function (muscle strength and range of motion) and quality of life. All these outcomes were assessed at pretreatment (baseline) and after the end of treatment at week eight (W8).

Conditions

Breast Cancer Lymphedema; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Group

The Kinect based rehabilitation group received virtual reality therapy using Xbox Kinect-based games, in addition to complex decongestive physiotherapy. The intervention was led once per day, five days a week, over 8 weeks. All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

Intervention was led once per day, five days a week, over 8 weeks.

Resistance exercise Group

The resistance exercise group received resistance training, in addition to complex decongestive physiotherapy. The intervention was led once per day, five days a week, over 8 weeks. All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.

Group Type: EXPERIMENTAL

Resistance Exercise

Intervention Type: OTHER

Intervention was led once per day, five days a week, over 8 weeks.

Interventions

Virtual Reality

Intervention was led once per day, five days a week, over 8 weeks.

Intervention Type: OTHER

Resistance Exercise

Intervention was led once per day, five days a week, over 8 weeks.

Intervention Type: OTHER

Other Intervention Names

complex decongestive physiotherapy; complex decongestive physiotherapy

Eligibility Criteria

Inclusion Criteria

• Age more than 30.
• Histological diagnosis of breast cancer at least 1 year prior to the study.
• Clinical diagnosis of unilateral Breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons.
• Clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference.

Exclusion Criteria

• Unstable lymphedema, receiving intensive therapy within the previous 3 months.
• A musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Maged Basha

Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maged Basha, PhD

Role: PRINCIPAL_INVESTIGATOR

College of medical rehabilitation, Qassim University

Fatma Alzahraa Kamel, PhD

Role: STUDY_DIRECTOR

Cairo University

Locations

Shorook Physical Therapy Centers

Cairo, , Egypt

Countries

Egypt

References

Vicini F, Shah C, Arthur D. The Increasing Role of Lymphedema Screening, Diagnosis and Management as Part of Evidence-Based Guidelines for Breast Cancer Care. Breast J. 2016 May;22(3):358-9. doi: 10.1111/tbj.12586. Epub 2016 Feb 29. No abstract available.

Reference Type: BACKGROUND

PMID: 26929240 (View on PubMed)

Morgan PA, Franks PJ, Moffatt CJ. Health-related quality of life with lymphoedema: a review of the literature. Int Wound J. 2005 Mar;2(1):47-62. doi: 10.1111/j.1742-4801.2005.00066.x.

Reference Type: BACKGROUND

PMID: 16722853 (View on PubMed)

Aguilar-Lazcano CA, Rechy-Ramirez EJ, Hu H, Rios-Figueroa HV, Marin-Hernandez A. Interaction Modalities Used on Serious Games for Upper Limb Rehabilitation: A Systematic Review. Games Health J. 2019 Oct;8(5):313-325. doi: 10.1089/g4h.2018.0129. Epub 2019 Jul 9.

Reference Type: RESULT

PMID: 31287734 (View on PubMed)

Basha MA, Aboelnour NH, Alsharidah AS, Kamel FH. Effect of exercise mode on physical function and quality of life in breast cancer-related lymphedema: a randomized trial. Support Care Cancer. 2022 Mar;30(3):2101-2110. doi: 10.1007/s00520-021-06559-1. Epub 2021 Oct 20.

Reference Type: DERIVED

PMID: 34669036 (View on PubMed)

Other Identifiers

2449PT

Identifier Type: -

Identifier Source: org_study_id