Trial Title:
The Effect of Hand Exercises on Upper Limb Volume, Quality of Life, and Hand Function in Breast Cancer Survivors
NCT ID:
NCT05983380
Condition:
Breast Cancer Lymphedema
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Participant)
Masking description:
Participants will be masked regarding whether they are assigned to the intervention or
comparison group.
Intervention:
Intervention type:
Other
Intervention name:
Hand Mobility and Grip Strengthening Exercises
Description:
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.
Arm group label:
Experimental
Intervention type:
Other
Intervention name:
Usual Care
Description:
Manual lymphatic drainage, compression, exercise, skin hygiene.
Arm group label:
Comparison
Arm group label:
Experimental
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Biologic women due to increased prevalence of breast cancer diagnosis.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Presbyterian Healthplex
Address:
City:
Albuquerque
Zip:
87109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elisabeth Wise, DPT
Email:
EWise@phs.org
Facility:
Name:
Presbyterian Southern Outpatient Rehab
Address:
City:
Rio Rancho
Zip:
87124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elisabeth Wise, DPT
Email:
EWise@phs.org
Facility:
Name:
Presbyterian Santa Fe Medical Center
Address:
City:
Santa Fe
Zip:
87507
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elisabeth Wise, DPT
Email:
EWise@phs.org
Start date:
October 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Texas Woman's University
Agency class:
Other
Collaborator:
Agency:
Presbyterian Healthcare Services
Agency class:
Other
Source:
Texas Woman's University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983380
