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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00389844
First received: October 18, 2006
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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

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 report of exercise [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Falls [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: Yes ]
  • Fall-related injuries [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: Yes ]
  • Fear of falling [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
  • 36-item short-form health survey (SF-36) [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 2, 6, and 12 months post hip fracture ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: July 2000
Study Completion Date: September 2005
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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-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
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: NCT00389844

Locations
United States, Maryland
St. Agnes Hospital
Baltimore, Maryland, United States, 21229
Greater Baltimore Medical Center (GBMC)
Baltimore, Maryland, United States, 21204
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
Harbor Hospital Center
Baltimore, Maryland, United States, 21225
North Arundel Hospital
Glen Burnie, Maryland, United States, 21061
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Jay Magaziner, Ph.D., MSHyg University of Maryland
  More Information

No publications provided

Responsible Party: Barbara Resnick, RN / Principal Investigator, University of Maryland School of Nursing
ClinicalTrials.gov Identifier: NCT00389844     History of Changes
Other Study ID Numbers: H-22361, 5 R01 AG017082-04
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
exercise
motivation

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

ClinicalTrials.gov processed this record on August 21, 2014