Clinical trial NCT04724356: Effect of Exercise Mode in Breast Cancer-Related Lymphedema
Official title: Effect of Exercise Mode on Physical Function and Quality of Life in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Quality of Life
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-01-26
Enrollment: 52
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Limb volume measurement
timeFrame: at baseline
measure: Limb volume measurement
timeFrame: after 8 weeks
measure: Limb volume measurement
timeFrame: after 12 weeks
measure: Health-related quality of life, Medical Outcomes Study short-form (SF-36)
timeFrame: at baseline
measure: Health-related quality of life, Medical Outcomes Study short-form (SF-36)
timeFrame: after 8 weeks
measure: Health-related quality of life, Medical Outcomes Study short-form (SF-36)
timeFrame: after 12 weeks
Secondary outcomes:
measure: Shoulder range of motion
timeFrame: at baseline
measure: Shoulder range of motion
timeFrame: after 8 weeks
measure: Shoulder range of motion
timeFrame: after 12 weeks
measure: Visual analogue scale
timeFrame: at baseline
measure: Visual analogue scale
timeFrame: after 8 weeks
measure: Visual analogue scale
timeFrame: after 12 weeks
measure: Muscle strength
timeFrame: at baseline
measure: Muscle strength
timeFrame: after 8 weeks
measure: Muscle strength
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shorook Physical Therapy Centers
Study officials:
affiliation: College of medical rehabilitation, Qassim University
name: Maged Basha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Fatma Alzahraa Kamel, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.