BHS4 - Bone/Muscle Changes Following Hip Fracture in Older White Women - Full Text View

Sponsors and Collaborators:	University of Maryland National Institute on Aging (NIA)
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00390741

Purpose

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	Intervention
Hip Fracture	Behavioral: Exercise Plus Program

MedlinePlus related topics: Exercise and Physical Fitness Fractures Hip Injuries and Disorders Hip Replacement Minerals

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Bone/Muscle Changes Following Hip Fracture in Older White Women

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Self-efficacy [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
Exercise behavior and activity [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
Subjective reporting of exercise [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compliance [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
Change in BMD [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
Lower extremity function [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
Falls [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: Yes ]
Time to weight bearing [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
Dietary intake [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]

Enrollment:	170
Study Start Date:	October 1998
Study Completion Date:	September 2005
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: No Intervention Usual care

Arms

Assigned Interventions

1: Active Comparator

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.

2: No Intervention

Usual care

Show Detailed Description

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hip fracture

Exclusion Criteria:

Male
Under 65 years old
Non-surgical repair of hip fracture
Non-community dwelling
Fractured more than 72 hours before admission to the hospital
Pathologic fracture
Resides more than 70 miles from the hospital of admission
Recent diagnosis (in past 6 months) of angina or myocardial infarction
Myocardial infarction or stroke concurrent with hip fracture
Diagnosis of ventricular arrhythmia, third degree heart block, atrial fibrillation or if vital signs equal heart less than 60 or greater than 100
Active or suspected myocarditis or pericarditis in the past year
Recent (within past 6 months) deep venous thrombosis or intracardiac thrombi
Persistent pulmonary edema during hospitalization
Poorly controlled blood pressure w/ resting systolic greater than 180 mm Hg or resting diastolic greater than 100 mm Hg (3 or more readings with 24- hour period)
Presence of ventricular aneurysm
Paget's Disease
Diabetes--blood sugar consistently greater than 300
Diagnosis of thyrotoxicosis or myxedema within past year
Any diagnosis of hyperparathyroidism, hypoparathyroidism, or osteomalacia
Parkinson's, multiple sclerosis, or ALS (Lou Gehrig's disease)
New (past 6 months) onset seizure disorder or seizure within the past 6 months
Diagnosis of schizophrenia
Recent (within past 6 months) GI hemorrhage or bleeding
Preadmission coumadin therapy
Cirrhosis or end stage renal disease (ESRD)
Advanced hepatitis, AIDS, or endocarditis
Cancer with metastases, or cancer under active treatment (chemotherapy with cytotoxic agents) other than non-melanomic skin cancers
Current diagnosis of chronic alcohol abuse
Preadmission narcotic use or preadmission benzodiazepine use more than 1 dose or tablet a day
Required human assistance to walk prior to fracture
Prior fracture
Chest pains when climbing a flight of stairs, while walking on level ground, or at rest prior to the hip fracture
Use of supplemental oxygen prior to fracture
Other (Non-English speaking, severe blindness, paraplegia, hemiplegia
Mini-Mental Status Exam score less than 20

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390741

Locations

United States, Maryland
St. Joseph's Hospital
Towson, Maryland, United States, 21204
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Northwest Hospital Center
Randallstown, Maryland, United States, 21133

Sponsors and Collaborators

University of Maryland

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Jay Magaziner, Ph.D., MSHyg

University of Maryland School of Medicine

More Information

No publications provided

Responsible Party:	University of Maryland School of Medicine ( Jay Magaziner, PhD, MSHyg/Principal Investigator )
Study ID Numbers:	H-20834, NIA R37 AG09901
Study First Received:	October 18, 2006
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00390741 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

hip fracture
bone mineral density
exercise

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 07, 2009