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Completed

NCT Number: NCT04724356

Effect of Exercise Mode in Breast Cancer-Related Lymphedema

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.

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Key information

Conditions

Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shorook Physical Therapy Centers

Cairo, 11241, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality

Other

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

Other names: complex decongestive physiotherapy

Resistance Exercise

Other

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

Other names: complex decongestive physiotherapy

Primary outcomes

  1. Limb volume measurement

    Time frame: at baseline

    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.

  2. Limb volume measurement

    Time frame: after 8 weeks

    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.

  3. Limb volume measurement

    Time frame: after 12 weeks

    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.

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

    Time frame: at baseline

    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.

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

    Time frame: after 8 weeks

    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.

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

    Time frame: after 12 weeks

    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.

Secondary outcomes

  1. Shoulder range of motion

    Time frame: at baseline

    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.

  2. Shoulder range of motion

    Time frame: after 8 weeks

    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.

  3. Shoulder range of motion

    Time frame: after 12 weeks

    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.

  4. Visual analogue scale

    Time frame: at baseline

    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)

  5. Visual analogue scale

    Time frame: after 8 weeks

    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)

  6. Visual analogue scale

    Time frame: after 12 weeks

    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)

  7. Muscle strength

    Time frame: at baseline

    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.

  8. Muscle strength

    Time frame: after 8 weeks

    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.

  9. Muscle strength

    Time frame: after 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Effect of Exercise Mode on Physical Function and Quality of Life in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial

Acronym: Lymphedema

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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