Women With Cancer: An Exercise Study to Promote Health

NCT ID: NCT01102985

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-03-31

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).

Conditions

Bone Loss; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

aerobic resistance

12 month aerobic resistance exercise at a fitness center

Group Type: EXPERIMENTAL

aerobic resistance exercise

Intervention Type: BEHAVIORAL

three times per week aerobic resistance exercise for 12 months

home based physical activity

national recommendations for physical activity for adults

Group Type: ACTIVE_COMPARATOR

home based health promotion

Intervention Type: BEHAVIORAL

education and support to adapt national guidelines for 30 minutes physical activity most days of the week

Interventions

aerobic resistance exercise

three times per week aerobic resistance exercise for 12 months

Intervention Type: BEHAVIORAL

home based health promotion

education and support to adapt national guidelines for 30 minutes physical activity most days of the week

Intervention Type: BEHAVIORAL

Other Intervention Names

physical activity; health promotion

Eligibility Criteria

Inclusion Criteria

• Female
• Cancer diagnosis
• Postmenopausal

Exclusion Criteria

• Health condition contraindication to moderate physical activity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Tish Knobf, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Knobf MT, Jeon S, Smith B, Harris L, Thompson S, Stacy MR, Insogna K, Sinusas AJ. The Yale Fitness Intervention Trial in female cancer survivors: Cardiovascular and physiological outcomes. Heart Lung. 2017 Sep-Oct;46(5):375-381. doi: 10.1016/j.hrtlng.2017.06.001. Epub 2017 Aug 10.

Reference Type: DERIVED

PMID: 28803675 (View on PubMed)

Other Identifiers

1R01CA122658-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0801003383

Identifier Type: -

Identifier Source: org_study_id