Strength Training Intervention for Breast Cancer Survivors and the Effects on Lymphedema Status
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of Pennsylvania.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Pennsylvania
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194363
First received: September 13, 2005
Last updated: January 15, 2008
Last verified: January 2008
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Purpose
The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.
Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.
| Condition | Intervention |
|---|---|
|
Lymphedema |
Behavioral: Strength training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | The PAL Trial (Physical Activity and Lymphedema) |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary aim 1: To assess changes in physical functioning of the arms, as measured by tests of range of motion, coordination, pain, and strength that may result from strength training. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Secondary aim 2: To assess changes in body composition that may occur from strength training. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Secondary aim 3: To assess self-reported changes in health related quality of life, sleep, fatigue, self-esteem, optimism, life satisfaction, sexual function, body image, social support, and general quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Secondary aim 4: To assess changes in psychosocial mediators of exercise behavior, as well as achievement of outcome expectancies that may occur from participation in strength training. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Secondary aim 5: To assess changes in biomarkers related to breast cancer, among the participants who start the study with a BMI over 25. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 295 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Behavioral: Strength training
13 weeks of supervised strength training (twice weekly for 90 minutes per session), 39 weeks of unsupervised strength training (twice weekly for 90 minutes per session)
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women without lymphedema must be 1-5 years post breast cancer diagnosis
- Women with lymphedema must be 1-15 years post breast cancer diagnosis
Women with lymphedema must have stable lymphedema. ONE of the following:
- 0-40>10% girth volume difference between the affected and non- affected limb for a non-dominant arm
6-40% girth volume difference between the affected and non- affected limb for a dominant arm inter-limb discrepancy in volume or circumference at the point of greatest visible difference OR swelling or obscuration of anatomic architecture upon close inspection OR pitting edema.
- 2 cm circumference difference
- A prior clinical diagnosis of lymphedema and having had any prior intensive lymphedema therapy on the affected arm
As well as ALL of the following four conditions:
Women with Lymphedema must have ALL of the following:
- No recorded arm girth change of 15% or greater within the three months.
- No more than one lymphedema related infection requiring antibiotics within the past 3 months.
- Participation in all Activities of Daily Living (ADLs) without lymphedema exacerbation for the past 3 months.
Exclusion Criteria:
For ALL participants (with and without lymphedema)
- No medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
- Not morbidly obese (body mass index >50 kg/m2)
- No plans for additional (e.g. reconstructive) surgery during the study period
- No bilateral breast cancers (because this prohibits our ability to assess the primary outcome of interest)
- No strength training or other upper body resistive exercise within the past year
- Not planning to move away from the area over the next year
- Not pregnant or lactating or planning to become pregnant during the study
- Among women who have given birth: at least 6 months post pregnancy and at least 3 months post lactation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194363
Locations
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
University of Pennsylvania
Investigators
| Principal Investigator: | Kathryn Schmitz, PhD, MPH | University of Pennsylvania |
More Information
No publications provided by University of Pennsylvania
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kathryn H. Schmitz/Principal Investigator, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00194363 History of Changes |
| Other Study ID Numbers: | R01 CA-106851-01 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 15, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pennsylvania:
|
breast cancer breast cancer survivors lymphedema strength training breast cancer survivorship |
Additional relevant MeSH terms:
|
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013