BHS4 - Bone/Muscle Changes Following Hip Fracture in Older White Women (Hip4)
|ClinicalTrials.gov Identifier: NCT00390741|
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : May 29, 2008
The major goals of this study are:
- To conduct an intervention development study to evaluate the feasibility of implementing an exercise intervention for reduction losses in bone mineral density, muscle mass, and strength, and clinically relevant aspects of functioning following a hip fracture, and to obtain preliminary tests of the effective ness of these interventions.
- To evaluate the effect of home-based exercise intervention on bone metabolism.
- To evaluate the effects of hip fracture on bone metabolism.
- To evaluate the effects of exercise and hip fracture on hormonal regulators.
- To evaluate the association between markers of bone metabolism hormone regulators, and BMD.
- To separate out the effects of hip fracture on bone turnover from those of aging in persons with low bone mineral density.
|Condition or disease||Intervention/treatment|
|Hip Fracture||Behavioral: Exercise Plus Program|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Bone/Muscle Changes Following Hip Fracture in Older White Women|
|Study Start Date :||October 1998|
|Primary Completion Date :||September 2004|
|Study Completion Date :||September 2005|
Active Comparator: 1
Home-based exercise program
Behavioral: Exercise Plus Program
Those assigned to the treatment group were visited by an exercise trainer three times a week for the first two months of the study, two times per week during months three and four, one time per week during months five and six, two times a month during months seven and eight, and one time a month during months nine through twelve. During months seven through twelve of the study the trainer contacted the participant by telephone once each week during the weeks that he or she did not go the participants' home.
Other Name: Exercise
No Intervention: 2
- Self-efficacy [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Exercise behavior and activity [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Subjective reporting of exercise [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Compliance [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Change in BMD [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Lower extremity function [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Falls [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Time to weight bearing [ Time Frame: 2, 6, and 12 months post hip fracture ]
- Dietary intake [ Time Frame: 2, 6, and 12 months post hip fracture ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390741
|United States, Maryland|
|Union Memorial Hospital|
|Baltimore, Maryland, United States, 21218|
|Northwest Hospital Center|
|Randallstown, Maryland, United States, 21133|
|St. Joseph's Hospital|
|Towson, Maryland, United States, 21204|
|Principal Investigator:||Jay Magaziner, Ph.D., MSHyg||University of Maryland|