Women With Cancer: An Exercise Study to Promote Health

Yale University

Status: Completed

Conditions: Cancer; Bone Loss

Treatments: Behavioral: home based health promotion; Behavioral: aerobic resistance exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01102985

1R01CA122658-01A2 (U.S. NIH Grant/Contract)

0801003383

Details and patient eligibility

About

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.

Full 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).

Enrollment: 154 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Cancer diagnosis
• Postmenopausal

Exclusion criteria

• Health condition contraindication to moderate physical activity

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

154 participants in 2 patient groups

aerobic resistance

Experimental group

Description:

12 month aerobic resistance exercise at a fitness center

Treatment:

Behavioral: aerobic resistance exercise

home based physical activity

Active Comparator group

Description:

national recommendations for physical activity for adults

Treatment:

Behavioral: home based health promotion