The Women In Steady Exercise Research (WISER) Survivor Trial
Հիմնաբառեր
Վերացական
Ամսաթվերը
| Վերջին ստուգումը: | 05/31/2019 |
| Առաջինը ներկայացվում է: | 01/17/2012 |
| Մոտավոր գրանցումը ներկայացված է: | 01/17/2012 |
| Առաջին տեղադրումը: | 01/22/2012 |
| Վերջին թարմացումը ներկայացված է: | 06/20/2019 |
| Վերջին թարմացումը տեղադրված է: | 06/23/2019 |
| Ուսումնասիրության իրական մեկնարկի ամսաթիվը: | 12/31/2011 |
| Նախնական ավարտման նախնական ամսաթիվը: | 04/30/2016 |
| Ուսումնասիրության ավարտի գնահատման ամսաթիվը: | 04/30/2016 |
Վիճակ կամ հիվանդություն
Միջամտություն / բուժում
Behavioral: Exercise Intervention
Behavioral: Weight Loss Intervention
Փուլ
Arm խմբերը
| Արմ | Միջամտություն / բուժում |
|---|---|
| No Intervention: Lymphedema Care Only All 4 groups receive lymphedema care as follows:
2 custom fitted compression garments (baseline and 6 months)
evaluations for flare-ups at request (and at each measurement time point)
lymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions. | |
| Experimental: Exercise only The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above. | |
| Experimental: Weight loss only The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above. | |
| Experimental: Exercise and Weight loss combined Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above. |
Իրավասության չափանիշներ
| Ուսումնասիրության իրավունք ունեցող սեռերը | Female |
| Ընդունում է առողջ կամավորներ | Այո |
| Չափանիշներ | Inclusion Criteria: - breast cancer survivor - overweight or obese (BMI of 25 or greater) - must have breast cancer related lymphedema - at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis - the eligible age range will have no lower limit. - currently free of cancer Exclusion Criteria: - medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims - inability to walk for 6 minutes unaided - extremely obese (body mass index greater or equal to 50 kg/m2) - plans for additional (e.g. curative or reconstructive) surgery during the study period - self-report of weight-lifting within the past year - already engaging in 3 or more times weekly aerobic activity of moderate intensity - planning to move away from the area over the next year - current use of weight loss medication (OTC or prescription) - self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week) - weight loss of greater than 10 % in the past 3 months - history of bariatric surgery - women who are pregnant |
Արդյունք
Արդյունքների առաջնային միջոցառումներ
1. Percent interlimb difference, change over 12 months. [Baseline and 12 months]
Արդյունքների երկրորդական միջոցներ
1. Clinical Lymphedema Events [Data collected over the 12 month follow-up, with events collected as reported]
2. Clinical Evaluation Score for Lymphedema [Baseline and 12 months]
3. Norman Lymphedema Survey [Baseline and 12 months]
4. Weight loss [Baseline and 12 months]
5. Biomarkers: Estradiol [baseline and 12 months]
6. Biomarkers: Testosterone [baseline and 12 months]
7. Biomarkers - Sex Hormone Binding Globulin [baseline and 12 months]
8. Inflammation: Interleukin six [baseline and 12 months]
9. Inflammation: C reactive protein [baseline and 12 months]
10. Adiponectin [baseline and 12 months]
11. Leptin [baseline and 12 months]
12. F2-isoprostanes [baseline and 12 months]
13. Insulin [baseline and 12 months]
14. Glucose [baseline and 12 months]
15. insulin like growth factor one [baseline and 12 months]
16. insulin like growth factor binding protein three [baseline and 12 months]
17. Upper limb lymphedema twenty seven [baseline and 12 months]
18. body image and relationship survey [baseline and 12 months]
Արդյունքների այլ միջոցառումներ
1. breast cancer recurrence [10 years post trial]
2. mortality [10 years post trial]
