The Effect of Hand Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Hand Mobility and Grip Strengthening Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Other: Hand Mobility and Grip Strengthening Exercises
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb. | Other: Hand Mobility and Grip Strengthening Exercises<br>* 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.<br>Other: Usual Care<br>* Manual lymphatic drainage, compression, exercise, skin hygiene.<br>|
| Active Comparator: Comparison<br>Participants will receive only the usual care for breast cancer-related lymphedema. | Other: Usual Care<br>* Manual lymphatic drainage, compression, exercise, skin hygiene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Limb volume | Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR. | Day 1, at 4 weeks, at 8 weeks of treatment/completion of study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength | Grip Strength assessed with Jamar Hand Dynamometer. | Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study. | 
| Nine-Hole Peg Test | Nine-Hole Peg Test with affected limb only to assess dexterity. | Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study. | 
| Lymphedema Life Impact Scale | Participants fill out Lymphedema Life Impact Scale, a self-report survey to assess quality of life. | Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study. |