BHS5 - Testing the Effectiveness of the Exercise Plus Program (Hip5)

• ClinicalTrials.gov Identifier: NCT00389844
• Recruitment Status: Completed
• First Posted: October 19, 2006
• Last Update Posted: May 29, 2008
• Sponsor: University of Maryland, College Park
• Collaborator: National Institute on Aging (NIA)
• Information provided by: University of Maryland, Baltimore

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hip Fracture	Behavioral: Exercise Trainer component of the Exercise Plus Program; Behavioral: Plus component (motivation) of the Exercise Plus Program; Behavioral: Exercise Plus Program (exercise + motivation)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Testing the Effectiveness of the Exercise Plus Program on Efficacy Expectations, Exercise Behavior & Activity of Older Adults Following a Hip Fracture
• Study Start Date: July 2000
• Actual Primary Completion Date: September 2004
• Actual Study Completion Date: September 2005

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 1; Routine care
Active Comparator: 2; Exercise only	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.; Other Name: Exercise
Active Comparator: 3; Motivation only	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.; Other Name: Exercise; Behavioral: Plus component (motivation) of the Exercise Plus Program; Motivation only; Other Name: Motivation
Experimental: 4; Exercise plus motivation	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.; Other Name: Exercise; Behavioral: Plus component (motivation) of the Exercise Plus Program; Motivation only; Other Name: Motivation; Behavioral: Exercise Plus Program (exercise + motivation); Exercise plus motivation; Other Names: Exercise; Motivation

Outcome Measures

Primary Outcome Measures :

1. Self-efficacy [ Time Frame: 2, 6, and 12 months post hip fracture ]
2. Exercise behavior and activity [ Time Frame: 2, 6, and 12 months post hip fracture ]
3. Subjective report of exercise [ Time Frame: 2, 6, and 12 months post hip fracture ]

Secondary Outcome Measures :

1. Falls [ Time Frame: 2, 6, and 12 months post hip fracture ]
2. Fall-related injuries [ Time Frame: 2, 6, and 12 months post hip fracture ]
3. Fear of falling [ Time Frame: 2, 6, and 12 months post hip fracture ]
4. Pain [ Time Frame: 2, 6, and 12 months post hip fracture ]
5. 36-item short-form health survey (SF-36) [ Time Frame: 2, 6, and 12 months post hip fracture ]
6. Depression [ Time Frame: 2, 6, and 12 months post hip fracture ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Greater Baltimore Medical Center (GBMC)

Baltimore, Maryland, United States, 21204

Harbor Hospital Center

Baltimore, Maryland, United States, 21225

St. Agnes Hospital

Baltimore, Maryland, United States, 21229

Franklin Square Hospital

Baltimore, Maryland, United States, 21237

North Arundel Hospital

Glen Burnie, Maryland, United States, 21061

Sponsors and Collaborators

University of Maryland, College Park

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Jay Magaziner, Ph.D., MSHyg; University of Maryland, College Park

More Information

• Responsible Party: Barbara Resnick, RN / Principal Investigator, University of Maryland School of Nursing
• ClinicalTrials.gov Identifier: NCT00389844
• Other Study ID Numbers: H-22361; 5R01AG017082-04 ( U.S. NIH Grant/Contract )
• First Posted: October 19, 2006
• Last Update Posted: May 29, 2008
• Last Verified: May 2008

Keywords provided by University of Maryland, Baltimore:

hip fracture; exercise; motivation

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries