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临床试验/NCT00390741
NCT00390741已完成不适用

Bone/Muscle Changes Following Hip Fracture in Older White Women

University of Maryland, Baltimore6 个研究点 分布在 1 个国家目标入组 170 人开始时间: 1998年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
6
主要终点
Self-efficacy

研究概览

简要总结

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.

详细描述

Hip fracture is a major public health problem, with striking consequences for the older patient, her family and the health care system. More than 350,000 persons over age 65 will fracture a hip in the United States during the coming year at an estimated annual cost of over $12 billion; by 2040, over 650,000 hip fractures will occur annually in this group. Between 18-33% of older hip fracture patients die within one year of their fracture, depending upon the specific population studied. Most surviving hip fracture patients experience reduced mobility and lose their ability to function independently. As many as 45% of those who are community dwelling at the time of their fracture are discharged to institutions post-hospitalization, and 15-25% remain institutionalized for a year post-fracture. Further, significant strain is observed in over a third of family caregivers as long as a year post-fracture. Depending upon the population studied and function being assessed, an estimated 25-75% of those who are independent before their fracture can neither walk independently nor achieve their previous level of independent living within a year following their fracture and 10- 20% of those who sustained a hip fracture can expect to have another osteoporotic fracture within two years.

This protocol consists of two components related to the recovery after hip fracture (described below):

EXERCISE INTERVENTION TRIAL. With few exceptions, which are restricted primarily to studies of comprehensive in-patient rehabilitation, little systematic attention has been given to evaluating strategies for improving functioning, bone, and muscle post-hip fracture. Strategies that have been shown to improve bone, muscle, and function in older persons who have not fractured a hip may be useful if applied to persons following hip fracture. Exercise is one of the strategies that have received considerable attention. Exercise training in older adults also has beneficial effects on bone density, muscle strength, and physical functioning, as well as cardiovascular fitness, and risk reduction for falls and fractures. An exercise program that combines weight-bearing and resistance exercises can increase bone mineral content in postmenopausal women. Little information is available on whether a home-based exercise program can be used to achieve similar benefits compared to a more structured, on-site exercise program. This issue is particularly relevant in older, frail women who have sustained a hip fracture because many are unable and unwilling to travel to exercise facilities.

Results of the studies of exercise are instructive of potential benefits for older persons following hip fracture. Most of the work to date has been restricted to relatively healthy, select samples of older persons who have been recruited into rigorously controlled randomized experiments. Hence, while they are efficacious in benefiting a select group of older persons, it is not known whether these interventions will be accepted by a frail older population which has become suddenly disabled by a hip fracture, nor is it known whether these interventions will be beneficial to this group which is losing bone, muscle and function at an accelerated rate.

Because losses in BMD following hip fracture place these women at greater rise of subsequent fracture and may delay or prevent full recovery of ambulatory ability, it is important to optimize fracture healing and prevent loss of bone. One therapeutic option for these patients that may be effective is to increase physical activity through exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Hip fracture

排除标准

  • 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

结局指标

主要结局

Self-efficacy

时间窗: 2, 6, and 12 months post hip fracture

Exercise behavior and activity

时间窗: 2, 6, and 12 months post hip fracture

Subjective reporting of exercise

时间窗: 2, 6, and 12 months post hip fracture

次要结局

  • Time to weight bearing(2, 6, and 12 months post hip fracture)
  • Lower extremity function(2, 6, and 12 months post hip fracture)
  • Falls(2, 6, and 12 months post hip fracture)
  • Dietary intake(2, 6, and 12 months post hip fracture)
  • Compliance(2, 6, and 12 months post hip fracture)
  • Change in BMD(2, 6, and 12 months post hip fracture)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay S. Magaziner

Chair, Department Of Epidemiology & Public Health; Director, Center For Research On Aging

University of Maryland, Baltimore

研究点 (6)

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