Clinical trial NCT05983380: The Effect of Hand Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors
Official title: The Effect of Hand Mobility and Grip Strengthening Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Presbyterian Healthcare Services
First posted: 2023-08-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be compared, with treatment occurring at the same time. One group will receive the experimental exercises plus the usual treatment, the comparison group will only receive the usual treatment for breast cancer-related lymphedema.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the addition of simple hand mobility and grip strengthening exercises to the usual care for upper extremity lymphedema will reduce limb volume and improve the quality of life, hand dexterity, and grip strength for those experiencing breast cancer-related lymphedema. Researchers will compare those receiving the usual treatment to those receiving the usual treatment plus hand mobility and grip strengthening exercises.

Detailed description: The purpose of this study is to determine whether the addition of simple hand mobility and grip strengthening exercises to the usual care for upper extremity lymphedema will reduce limb volume and improve the quality of life, hand dexterity, and grip strength for those experiencing early, moderate, or late stage breast cancer-related lymphedema.

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.

Eligibility criteria: Inclusion Criteria:

* Biologic women age 18 years or older with a diagnosis of clinical lymphedema of one upper extremity-early (clinical), moderate, or late stage, following treatment for breast cancer within the previous 10 years.
* 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:

* Prior history of paresis in either upper limb, though paresis related to nerve compression from increased lymphatic volume will be eligible for inclusion.
* 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.

Primary outcomes:
measure: Upper Limb volume
timeFrame: Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.
Secondary outcomes:
measure: Grip Strength
timeFrame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
measure: Nine-Hole Peg Test
timeFrame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
measure: Lymphedema Life Impact Scale
timeFrame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Presbyterian Healthplex
state: New Mexico
city: Rio Rancho
country: United States
facility: Presbyterian Southern Outpatient Rehab
state: New Mexico
city: Santa Fe
country: United States
facility: Presbyterian Santa Fe Medical Center
state: New Mexico
Study officials:
affiliation: Texas Woman's University
name: Elisabeth Wise, DPT
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.