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

April 15, 2024 updated by: Elisabeth Wise, Texas Woman's University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elisabeth Wise, DPT
  • Phone Number: 505-772-1770
  • Email: EWise@phs.org

Study Contact Backup

  • Name: Tiffany Ryan, MOT/R
  • Phone Number: 505-772-1775
  • Email: TRyan3@phs.org

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Presbyterian Healthplex
        • Contact:
      • Rio Rancho, New Mexico, United States, 87124
        • Recruiting
        • Presbyterian Southern Outpatient Rehab
        • Contact:
      • Santa Fe, New Mexico, United States, 87507
        • Recruiting
        • Presbyterian Santa Fe Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other: Usual Care
Manual lymphatic drainage, compression, exercise, skin hygiene.
Active Comparator: Comparison
Participants will receive only the usual care for breast cancer-related lymphedema.
Other: Usual Care
Manual lymphatic drainage, compression, exercise, skin hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Limb volume
Time Frame: 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.
Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
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
Time Frame: 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.
Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
Lymphedema Life Impact Scale
Time Frame: 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.
Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Collaborators

Presbyterian Healthcare Services

Investigators

  • Principal Investigator: Elisabeth Wise, DPT, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

August 5, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FY2023-183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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