An interventional study of Hand Mobility and Grip Strengthening Exercises and Usual Care in Breast Cancer Lymphedema, sponsored by Texas Woman's University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Texas Woman's University · Not applicable, Interventional, and Treatment
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.
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.
124 studies on the registry are indexed under Breast Cancer Lymphedema; 40 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 97 interventional studies indexed under Breast Cancer Lymphedema.
Browse Breast Cancer Lymphedema studies →Texas Woman's University is the lead sponsor of 83 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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 · Other: Usual Care
Participants will receive only the usual care for breast cancer-related lymphedema.
Other: Usual Care
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.
Manual lymphatic drainage, compression, exercise, skin hygiene.
Upper Limb volume
Circumferential measurements of the upper limb, converted to volumetric measurements with frustrum equation through Epic EMR.
Time frame: Day 1, at 4 weeks, at 8 weeks of treatment/completion of study.
Grip Strength
Grip Strength assessed with Jamar Hand Dynamometer.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, at 4 weeks, and at 8 weeks of treatment/completion of study.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No plan to share IPD with other researchers.
Started Oct 2023 (actual). Primary completion is estimated for Sep 2024, 11 months after the start.
Of 66 non-industry interventional studies with no phase under Breast Cancer Lymphedema, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 11 months is below that.
Counting every sponsor, half of 69 studies reached it within 18 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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