- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00389844
BHS5 - Testing the Effectiveness of the Exercise Plus Program (Hip5)
Testing the Effectiveness of the Exercise Plus Program on Efficacy Expectations, Exercise Behavior & Activity of Older Adults Following a Hip Fracture
The major goals of this study are:
To implement a self-efficacy based intervention to strengthen efficacy beliefs related to exercise, decrease perceived barriers to exercise, and increase exercise behavior and overall activity of older women who have sustained a hip fracture.
To test the effectiveness of the Exercise Trainer component of the intervention on exercise behavior, activity, efficacy expectations, barriers to exercise, performance behaviors, overall health status, mood, pain, fear of falling, falls and fall-related injuries at 2, 6, and 12 months following fracture.
Study Overview
Status
Conditions
Detailed Description
Hip fracture is a major public health problem with striking consequences for the older adult, his or her family, and the health care system. By the year 2040, over 650,00 hip fractures will occur annually in older adults over the age 65. Many surviving the hip fracture will have decreased functional performance and be unable to live independently in the community. Moreover, the greatest loss in bone density and muscle strength occurs in the first two months post hip fracture. Recovery following a hip fracture has been shown to be greatly facilitated by participation in a rehabilitation program, and continued participation in a regular exercise program can increase functional recovery, muscle strength, and prevent future fractures. Despite the benefits of exercise, it is difficult to initiate exercise activity in older adults, and helping them adhere to an exercise regime is even more challenging. Self-efficacy, a belief in the individual's capabilities to perform a course of action to attain a desired outcome, and outcome expectancy, the belief that carrying out behavior will lead to a desired outcome, are hypothesized to be critical factors in adhering to a regular exercise program.
A total of 240 subjects (60 per group) from five area hospitals meeting the eligibility criteria will be recruited into the study. A study nurse will periodically contact a designated liaison at each hospital to obtain the names of patients with hip fractures. Following identification, a study nurse will contact the patient to enroll them in the study.
An experimental 2 X 2 factorial design with repeated measures will be used to test the impact of a self-efficacy based intervention on exercise behavior, activity, efficacy beliefs and barriers, performance, health status, mood, falls, fear of falling, and fall-related injuries of older adults who sustained a hip fracture.
Participants will be randomized after consent is obtained and the baseline evaluation completed. Participants will be randomly assigned to one of the four groups defined by the 2 X 2 design: (1) the Exercise Only component (2) the Plus (motivation) component; (3) Exercise Plus (exercise + motivation) components, and (4) routine care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21225
- Harbor Hospital Center
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Baltimore, Maryland, United States, 21229
- St. Agnes Hospital
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Baltimore, Maryland, United States, 21237
- Franklin Square Hospital
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Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center (GBMC)
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Glen Burnie, Maryland, United States, 21061
- North Arundel Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hip fracture
Exclusion Criteria:
- Male
- Under 65 years old
- Non-community dwelling
- Fractured more than 72 hours before admission to the hospital
- Pathologic fracture
- Resides more than 70 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=heart <60 or >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 >180 mm Hg or resting diastolic >100 mm Hg (3 or more readings with 24-hour period)
- Presence of ventricular aneurysm
- Paget's Disease
- Diabetes with blood sugar consistently > 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
- 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 <20
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
Routine care
|
|
Active Comparator: 2
Exercise only
|
With the exception of the routine care group, the exercise trainers visited each of the participant in their homes twice a week for two months, once a week for four months, and once a month for six months.
Other Names:
|
Active Comparator: 3
Motivation only
|
With the exception of the routine care group, the exercise trainers visited each of the participant in their homes twice a week for two months, once a week for four months, and once a month for six months.
Other Names:
Motivation only
Other Names:
|
Experimental: 4
Exercise plus motivation
|
With the exception of the routine care group, the exercise trainers visited each of the participant in their homes twice a week for two months, once a week for four months, and once a month for six months.
Other Names:
Motivation only
Other Names:
Exercise plus motivation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-efficacy
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
Exercise behavior and activity
Time Frame: 2, 6, and 12 months post hip fracture
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2, 6, and 12 months post hip fracture
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Subjective report of exercise
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Falls
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
Fall-related injuries
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
Fear of falling
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
Pain
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
36-item short-form health survey (SF-36)
Time Frame: 2, 6, and 12 months post hip fracture
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2, 6, and 12 months post hip fracture
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Depression
Time Frame: 2, 6, and 12 months post hip fracture
|
2, 6, and 12 months post hip fracture
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jay Magaziner, Ph.D., MSHyg, University of Maryland School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-22361
- 5R01AG017082-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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