Clinical Trials Directory

Trials / Completed

CompletedNCT00389844

BHS5 - Testing the Effectiveness of the Exercise Plus Program

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
240 (actual)
Sponsor
University of Maryland, Baltimore · Academic / Other
Sex
Female
Age
65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExercise Trainer component of the Exercise Plus ProgramWith 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.
BEHAVIORALPlus component (motivation) of the Exercise Plus ProgramMotivation only
BEHAVIORALExercise Plus Program (exercise + motivation)Exercise plus motivation

Timeline

Start date
2000-07-01
Primary completion
2004-09-01
Completion
2005-09-01
First posted
2006-10-19
Last updated
2022-03-22

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00389844. Inclusion in this directory is not an endorsement.