BHS4 - Bone/Muscle Changes Following Hip Fracture in Older White Women (Hip4)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00390741
First received: October 18, 2006
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

The major goals of this study are:

  1. 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.
  2. To evaluate the effect of home-based exercise intervention on bone metabolism.
  3. To evaluate the effects of hip fracture on bone metabolism.
  4. To evaluate the effects of exercise and hip fracture on hormonal regulators.
  5. To evaluate the association between markers of bone metabolism hormone regulators, and BMD.
  6. 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Bone/Muscle Changes Following Hip Fracture in Older White Women

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Jay Magaziner, Ph.D., MSHyg University of Maryland
  More Information

No publications provided by University of Maryland

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

Keywords provided by University of Maryland:
hip fracture
bone mineral density
exercise

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 22, 2014