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

Not Applicable

Recruiting

• Conditions: Breast Cancer Lymphedema
• Interventions: Other: Hand Mobility and Grip Strengthening Exercises; Other: Usual Care

• Registration Number: NCT05983380
• Lead Sponsor: Texas Woman's University

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.

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-05
• Study First Posted: 2023-08-09
• Study Start: 2023-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Usual Care	Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb.
Comparison	Usual Care	Participants will receive only the usual care for breast cancer-related lymphedema.
Experimental	Hand Mobility and Grip Strengthening Exercises	Participants will receive hand mobility and grip strengthening exercises in addition to the usual care for breast cancer-related lymphedema of the upper limb.

Primary Outcome Measures

Name	Time	Method
Upper Limb volume	Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.	Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Presbyterian Santa Fe Medical Center; 🇺🇸 Santa Fe, New Mexico, United States

Presbyterian Healthplex; 🇺🇸 Albuquerque, New Mexico, United States

Presbyterian Southern Outpatient Rehab; 🇺🇸 Rio Rancho, New Mexico, United States