NCT02056067

Hormones and Physical Exercise (HOPE) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.

Detailed description

The investigators propose to examine, in 121 postmenopausal breast cancer survivors who have been taking an AI for at least 2 months and are currently experiencing at least mild arthralgia associated with AI use, the effect of a randomized controlled exercise intervention vs. attention control (health education) on severity of arthralgia, endocrine-related Quality of Life(QOL), Bone Mineral Density(BMD), and mediators/mechanisms influencing the effect of exercise on arthralgia severity. Women will be randomized to a year long exercise program or attention control group. Women randomized to exercise will participate in 150 min/wk of aerobic exercise and a twice-weekly strength training program. The investigators will conduct baseline, six-, and 12-month clinic visits, as well as a 3- and 9-month mailing to evaluate the effect of the intervention on study outcomes.

Conditions

• Breast Cancer
• Arthralgia

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.
BEHAVIORAL	Attention Control (Health Education)	The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-02-05
• Last updated: 2020-03-05

Locations

1 site across 1 country: United States