The Effect of Hand Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors
NCT ID: NCT05983380
Last Updated: 2024-04-17
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-10-01
2024-12-30
Brief Summary
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Detailed Description
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This study is an experimental clinical trial to determine the effectiveness of hand mobility and grip exercises on limb volume, quality of life, hand dexterity, and grip strength in women with breast cancer-related lymphedema. The two independent variables are group, a between-subject factor, and time, a within subject factor. There are two levels of the independent variable of group: (1)usual care plus hand exercises and (2) usual care alone. The independent variable of time will be assessed at three timepoints: initial to 4 weeks, 4 to 8 weeks, and initial to 8 weeks of intervention. The four dependent variables are: (1) upper limb volume, (2) quality of life, (3) hand dexterity, and (4) grip strength. If a relationship (r\>0.5) is found between any of the dependent variables, MANOVA will used for analysis. If no relationship is found, a 2x3 mixed ANOVA will be used to analyze each dependent variable without a significant relationship to the others. The comparison group will receive the usual physical or occupational therapy treatment, including compression bandaging, manual lymphatic drainage, shoulder and scapular muscle exercises, and education regarding skin hygiene and monitoring. The experimental group will receive the usual treatment plus additional hand mobility and grip strengthening exercises.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental
Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb.
Hand Mobility and Grip Strengthening Exercises
Addition of hand mobility and grip strengthening exercises to the usual care for breast cancer-related lymphedema to assess changes in limb volume, quality of life, and hand function.
Usual Care
Manual lymphatic drainage, compression, exercise, skin hygiene.
Comparison
Participants will receive only the usual care for breast cancer-related lymphedema.
Usual Care
Manual lymphatic drainage, compression, exercise, skin hygiene.
Interventions
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Hand Mobility and Grip Strengthening Exercises
Addition of hand mobility and grip strengthening exercises to the usual care for breast cancer-related lymphedema to assess changes in limb volume, quality of life, and hand function.
Usual Care
Manual lymphatic drainage, compression, exercise, skin hygiene.
Eligibility Criteria
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Inclusion Criteria
* Women concurrently receiving immunotherapy or chemotherapy are eligible for inclusion, but an additional information request may be necessary (e.g., any activity restrictions and nadir periods) to determine whether they can safely participate in the exercise activities and apply compression.
Exclusion Criteria
* Current open wounds (\> 0.5 inch in length or diameter) of the axilla or edematous upper limb would be excluded, though the presence of lymphorrhea without visible skin tears will be eligible for inclusion.
* Previous treatment for upper limb lymphedema or a prior diagnosis of congestive heart failure or end-stage renal disease due to the impact on edematous limbs and risk of cardiac overload.
* Women who cannot speak or read English or Spanish sufficiently to complete the Lymphedema Life Impact Scale or understand the consent forms, educational information, and printed exercises will be excluded.
18 Years
FEMALE
No
Sponsors
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Presbyterian Healthcare Services
UNKNOWN
Texas Woman's University
OTHER
Responsible Party
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Elisabeth Wise
Primary Investigator, Physical Therapist
Principal Investigators
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Elisabeth Wise, DPT
Role: PRINCIPAL_INVESTIGATOR
Texas Woman's University
Locations
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Presbyterian Healthplex
Albuquerque, New Mexico, United States
Presbyterian Southern Outpatient Rehab
Rio Rancho, New Mexico, United States
Presbyterian Santa Fe Medical Center
Santa Fe, New Mexico, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Ahmad FB, Anderson RN. The Leading Causes of Death in the US for 2020. JAMA. 2021 May 11;325(18):1829-1830. doi: 10.1001/jama.2021.5469. No abstract available.
Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.
Chromy A, Zalud L, Dobsak P, Suskevic I, Mrkvicova V. Limb volume measurements: comparison of accuracy and decisive parameters of the most used present methods. Springerplus. 2015 Nov 19;4:707. doi: 10.1186/s40064-015-1468-7. eCollection 2015.
Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.
De Groef A, Van Kampen M, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. Effectiveness of postoperative physical therapy for upper-limb impairments after breast cancer treatment: a systematic review. Arch Phys Med Rehabil. 2015 Jun;96(6):1140-53. doi: 10.1016/j.apmr.2015.01.006. Epub 2015 Jan 13.
Feys P, Lamers I, Francis G, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. The Nine-Hole Peg Test as a manual dexterity performance measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):711-720. doi: 10.1177/1352458517690824. Epub 2017 Feb 16.
Giray E, Akyuz G. Assessment of Family Caregiver Burden and Its Relationships Between Quality of Life, Arm Disability, Grip Strength, and Lymphedema Symptoms in Women with Postmastectomy Lymphedema: A Prospective Cross-Sectional Study. Eur J Breast Health. 2019 Feb 15;15(2):111-118. doi: 10.5152/ejbh.2019.4385. eCollection 2019 Apr.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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FY2023-183
Identifier Type: -
Identifier Source: org_study_id
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