Recruiting

Hand Exercises

Sponsor:

Texas Woman's University

Code:

NCT05983380

Conditions

Breast Cancer Lymphedema

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hand Mobility and Grip Strengthening Exercises

Usual Care

Study Details

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.

Conditions

Breast Cancer Lymphedema

Study ID

NCT05983380

Start date

Oct 1, 2023

Status verified date

Apr, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Comparison

Participants will receive only the usual care for breast cancer-related lymphedema.

Interventions

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.

Primary outcome measure

  • Upper Limb volume [ Time Frame: Day 1, at 4 weeks, at 8 weeks of treatment/completion of study. ]

Central Contacts and Locations

Central contacts

Elisabeth Wise, DPT

505-772-1770EWise@phs.org

Tiffany Ryan, MOT/R

505-772-1775TRyan3@phs.org

Locations

Presbyterian Healthplex

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Elisabeth Wise, DPT

EWise@phs.org

Presbyterian Southern Outpatient Rehab

Recruiting

Rio Rancho, New Mexico, United States, 87124

Contacts

Elisabeth Wise, DPT

EWise@phs.org

Presbyterian Santa Fe Medical Center

Recruiting

Santa Fe, New Mexico, United States, 87507

Contacts

Elisabeth Wise, DPT

EWise@phs.org

More Information

Sponsor

Texas Woman's University

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Woman's University on 2024-04-17.