Women With Cancer: An Exercise Study to Promote Health

Not Applicable

Completed

• Conditions: Cancer; Bone Loss
• Interventions: Behavioral: aerobic resistance exercise; Behavioral: home based health promotion

• Registration Number: NCT01102985
• Lead Sponsor: Yale University

Brief Summary

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

• Female
• Cancer diagnosis
• Postmenopausal

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Exclusion Criteria

• Health condition contraindication to moderate physical activity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aerobic resistance	aerobic resistance exercise	12 month aerobic resistance exercise at a fitness center
home based physical activity	home based health promotion	national recommendations for physical activity for adults

Primary Outcome Measures

Name	Time	Method
Bone mass-lumbar spine and hip (DEXA)	baseline, 12 months	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.

Secondary Outcome Measures

Name	Time	Method
body composition-% fat mass, % lean muscle mass (whole body DEXA)	baseline, 6, 12 months	Body composition will be assessed by waist circumference and whole body DEXA scan (% fat mass, % lean muscle mass) at baseline, 6 and 12 months

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States