Women With Cancer: An Exercise Study to Promote Health
An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors
2 other identifiers
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 1, 2015
June 1, 2015
5.2 years
January 19, 2010
June 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone mass-lumbar spine and hip (DEXA)
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.
baseline, 12 months
Secondary Outcomes (1)
body composition-% fat mass, % lean muscle mass (whole body DEXA)
baseline, 6, 12 months
Study Arms (2)
aerobic resistance
EXPERIMENTAL12 month aerobic resistance exercise at a fitness center
home based physical activity
ACTIVE COMPARATORnational recommendations for physical activity for adults
Interventions
three times per week aerobic resistance exercise for 12 months
education and support to adapt national guidelines for 30 minutes physical activity most days of the week
Eligibility Criteria
You may qualify if:
- Female
- Cancer diagnosis
- Postmenopausal
You may not qualify if:
- Health condition contraindication to moderate physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06536-0740, United States
Related Publications (1)
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.
PMID: 28803675DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. Tish Knobf, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2010
First Posted
April 13, 2010
Study Start
January 1, 2008
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 1, 2015
Record last verified: 2015-06