Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389844
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2006-10-18
Brief Title:
BHS5 - Testing the Effectiveness of the Exercise Plus Program
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Testing the Effectiveness of the Exercise Plus Program on Efficacy Expectations Exercise Behavior Activity of Older Adults Following a Hip Fracture
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hip5
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
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 65000 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 individuals 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG017082-04 | NIH | None | httpsreporternihgovquickSearch5R01AG017082-04 |