BHS5 - Testing the Effectiveness of the Exercise Plus Program

Hip Fracture Clinical Trial

— Hip5  

Official title:

Testing the Effectiveness of the Exercise Plus Program on Efficacy Expectations, Exercise Behavior & Activity of Older Adults Following a Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389844
• Other study ID #: H-22361
• Secondary ID: 5R01AG017082-04
• Status: Completed
• Phase: N/A
• Start date: July 2000
• Est. completion date: September 2005

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Behavioral:
• Exercise Trainer component of the Exercise Plus Program
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.
• Plus component (motivation) of the Exercise Plus Program
Motivation only
• Exercise Plus Program (exercise + motivation)
Exercise plus motivation

Locations

Country	Name	City	State
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Greater Baltimore Medical Center (GBMC)	Baltimore	Maryland
United States	Harbor Hospital Center	Baltimore	Maryland
United States	St. Agnes Hospital	Baltimore	Maryland
United States	North Arundel Hospital	Glen Burnie	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy		2, 6, and 12 months post hip fracture
Primary	Exercise behavior and activity		2, 6, and 12 months post hip fracture
Primary	Subjective report of exercise		2, 6, and 12 months post hip fracture
Secondary	Falls		2, 6, and 12 months post hip fracture
Secondary	Fall-related injuries		2, 6, and 12 months post hip fracture
Secondary	Fear of falling		2, 6, and 12 months post hip fracture
Secondary	Pain		2, 6, and 12 months post hip fracture
Secondary	36-item short-form health survey (SF-36)		2, 6, and 12 months post hip fracture
Secondary	Depression		2, 6, and 12 months post hip fracture