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
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Female
  • Cancer diagnosis
  • Postmenopausal

Exclusion Criteria:

  • Health condition contraindication to moderate physical activity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102985

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         
Sponsors and Collaborators
Yale University
Investigators
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 April 17, 2014