Women With Cancer: An Exercise Study to Promote Health
Recruitment status was Recruiting
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Purpose
The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program compared to a home based physical activity program on bone mass, body composition, metabolic risk factors and cardiovascular fitness in women with cancer who have completed therapy.
| Condition | Intervention |
|---|---|
|
Bone Loss Cancer |
Behavioral: aerobic resistance exercise Behavioral: home based health promotion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors |
- Bone mass-lumbar spine and hip (DEXA) [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]Serum biomarkers for bone (serum NTX and serum osteocalcin) will be drawn at baseline, 6 and 12 months. Bone mass for lumbar spine and hip will be measured by DEXA scan at baseline and 12 months.
- body composition-% fat mass, % lean muscle mass (whole body DEXA) [ Time Frame: baseline, 6, 12 months ] [ Designated as safety issue: No ]Body composition will be assessed by waist circumference and whole body DEXA scan (% fat mass, % lean muscle mass) at baseline, 6 and 12 months
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: aerobic resistance
12 month aerobic resistance exercise at a fitness center
|
Behavioral: aerobic resistance exercise
three times per week aerobic resistance exercise for 12 months
Other Name: physical activity
|
|
Active Comparator: home based physical activity
national recommendations for physical activity for adults
|
Behavioral: home based health promotion
education and support to adapt national guidelines for 30 minutes physical activity most days of the week
Other Name: health promotion
|
Detailed Description:
The proposed study will evaluate an endurance-resistive exercise intervention to attenuate the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean muscle mass, weight gain, decreased physical activity) in an at-risk population of female cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma who have completed primary and/or adjuvant therapy within the past three years and who are perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise intervention (N=75) versus a health promotion control group (N=75). The specific aims of the study are to: (1) examine the effects of an exercise intervention on bone mass (serum biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist circumference), (2) examine the effect of an exercise intervention on metabolic risk factors (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood pressure), and (3) examine the effects of an exercise intervention on functional status and cardiovascular fitness (exercise stress test).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female
- Cancer diagnosis
- Postmenopausal
Exclusion Criteria:
- Health condition contraindication to moderate physical activity
Contacts and Locations| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06536-0740 | |
| Contact: M. Tish Knobf, PhD 203-737-2357 tish.knobf@yale.edu | |
| Contact: Tracy Yale 203-785-7467 tracy.yale@yale.edu | |
| Principal Investigator: M. Tish Knobf, PhD | |
| Principal Investigator: | M. Tish Knobf, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | M. Tish Knobf, RN, PhD, Professor, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT01102985 History of Changes |
| Other Study ID Numbers: | 0801003383, 1R01CA122658-01A2 |
| Study First Received: | January 19, 2010 |
| Last Updated: | April 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
exercise physical activity intervention cancer survivor |
ClinicalTrials.gov processed this record on May 22, 2013