Effect of Exercise Mode in Breast Cancer-Related Lymphedema

Quality of Life Clinical Trial

— Lymphedema  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724356
• Other study ID #: 2449PT
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: September 2021
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 5, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Quality of Life

Intervention

Other:
• Virtual Reality
Intervention was led once per day, five days a week, over 8 weeks.
• Resistance Exercise
Intervention was led once per day, five days a week, over 8 weeks.

Locations

Country	Name	City	State
Egypt	Shorook Physical Therapy Centers	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Qassim University	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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 — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline
Primary	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.	after 8 weeks
Primary	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.	after 12 weeks
Primary	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.	at baseline
Primary	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.	after 8 weeks
Primary	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.	after 12 weeks
Secondary	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.	at baseline
Secondary	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.	after 8 weeks
Secondary	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.	after 12 weeks
Secondary	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)	at baseline
Secondary	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)	after 8 weeks
Secondary	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)	after 12 weeks
Secondary	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.	at baseline
Secondary	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.	after 8 weeks
Secondary	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.	after 12 weeks