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CompletedNCT04724356LymphedemaUpdated Sep 16, 2021

Effect of Exercise Mode in Breast Cancer-Related Lymphedema

An interventional study of Virtual Reality and Resistance Exercise in Breast Cancer Lymphedema and Quality of Life, sponsored by Qassim University. Completed at 1 site in Egypt. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by Qassim University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jan 2019, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Breast Cancer Lymphedema
  • Quality of Life
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 52 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Qassim University is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    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.

    Other: Virtual Reality

  • Experimental
    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.

    Other: Resistance Exercise

Interventions

  • OtherVirtual Reality

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

    Also known as: complex decongestive physiotherapy

  • OtherResistance Exercise

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

    Also known as: complex decongestive physiotherapy

06

What researchers measure

Primary outcomes

  1. Limb volume measurement

    assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.

    Time frame: at baseline

  2. Limb volume measurement

    assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.

    Time frame: after 8 weeks

  3. Limb volume measurement

    assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.

    Time frame: after 12 weeks

  4. Health-related quality of life, Medical Outcomes Study short-form (SF-36)

    assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.

    Time frame: at baseline

  5. Health-related quality of life, Medical Outcomes Study short-form (SF-36)

    assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.

    Time frame: after 8 weeks

  6. Health-related quality of life, Medical Outcomes Study short-form (SF-36)

    assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.

    Time frame: after 12 weeks

Secondary outcomes

  1. Shoulder range of motion

    Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position. External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.

    Time frame: at baseline

  2. Shoulder range of motion

    Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position. External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.

    Time frame: after 8 weeks

  3. Shoulder range of motion

    Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position. External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.

    Time frame: after 12 weeks

  4. Visual analogue scale

    used to quantify the severity of perceived pain, heaviness, and tightness. Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)

    Time frame: at baseline

  5. Visual analogue scale

    used to quantify the severity of perceived pain, heaviness, and tightness. Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)

    Time frame: after 8 weeks

  6. Visual analogue scale

    used to quantify the severity of perceived pain, heaviness, and tightness. Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)

    Time frame: after 12 weeks

  7. Muscle strength

    The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.

    Time frame: at baseline

  8. Muscle strength

    The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.

    Time frame: after 8 weeks

  9. Muscle strength

    The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.

    Time frame: after 12 weeks

07

Study locations

1 site
  • Shorook Physical Therapy Centers
    Cairo, 11241, Egypt
08

References and documents

Publications

  • 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. PubMed 26929240 ↗
  • 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. PubMed 16722853 ↗
  • 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. PubMed 31287734 ↗
  • 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. PubMed 34669036 ↗

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04724356
Lead sponsor
Qassim University
Collaborators
Cairo University
Responsible party
Maged Basha (Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah., Qassim University) — Principal investigator
First posted
Jan 26, 2021
Start date
Jan 15, 2019
Primary completion
Apr 20, 2020
Completion
May 5, 2020
Last update
Sep 16, 2021

Study contacts

Maged Basha, PhD
principal investigator · College of medical rehabilitation, Qassim University
Fatma Alzahraa Kamel, PhD
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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