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Women With Cancer: An Exercise Study to Promote Health

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01102985
First received: January 19, 2010
Last updated: April 12, 2010
Last verified: April 2010

January 19, 2010
April 12, 2010
January 2008
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01102985 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Women With Cancer: An Exercise Study to Promote Health
An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Bone Loss
  • Cancer
  • Behavioral: aerobic resistance exercise
    three times per week aerobic resistance exercise for 12 months
    Other Name: physical activity
  • 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
  • Experimental: aerobic resistance
    12 month aerobic resistance exercise at a fitness center
    Intervention: Behavioral: aerobic resistance exercise
  • Active Comparator: home based physical activity
    national recommendations for physical activity for adults
    Intervention: Behavioral: home based health promotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
August 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • Cancer diagnosis
  • Postmenopausal

Exclusion Criteria:

  • Health condition contraindication to moderate physical activity
Female
18 Years to 75 Years
No
United States
 
NCT01102985
0801003383, 1R01CA122658-01A2
No
M. Tish Knobf, RN, PhD, Professor, Principal Investigator, Yale University
Yale University
National Cancer Institute (NCI)
Principal Investigator: M. Tish Knobf, PhD Yale University
Yale University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP