BHS5 - Testing the Effectiveness of the Exercise Plus Program (Hip5)
Primary Purpose
Hip Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Trainer component of the Exercise Plus Program
Plus component (motivation) of the Exercise Plus Program
Exercise Plus Program (exercise + motivation)
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture, exercise, motivation
Eligibility 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
Sites / Locations
- Greater Baltimore Medical Center (GBMC)
- Harbor Hospital Center
- St. Agnes Hospital
- Franklin Square Hospital
- North Arundel Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Experimental
Arm Label
1
2
3
4
Arm Description
Routine care
Exercise only
Motivation only
Exercise plus motivation
Outcomes
Primary Outcome Measures
Self-efficacy
Exercise behavior and activity
Subjective report of exercise
Secondary Outcome Measures
Falls
Fall-related injuries
Fear of falling
Pain
36-item short-form health survey (SF-36)
Depression
Full Information
NCT ID
NCT00389844
First Posted
October 18, 2006
Last Updated
March 7, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00389844
Brief Title
BHS5 - Testing the Effectiveness of the Exercise Plus Program
Acronym
Hip5
Official Title
Testing the Effectiveness of the Exercise Plus Program on Efficacy Expectations, Exercise Behavior & Activity of Older Adults Following a Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
hip fracture, exercise, motivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Routine care
Arm Title
2
Arm Type
Active Comparator
Arm Description
Exercise only
Arm Title
3
Arm Type
Active Comparator
Arm Description
Motivation only
Arm Title
4
Arm Type
Experimental
Arm Description
Exercise plus motivation
Intervention Type
Behavioral
Intervention Name(s)
Exercise Trainer component of the Exercise Plus Program
Other Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Plus component (motivation) of the Exercise Plus Program
Other Intervention Name(s)
Motivation
Intervention Description
Motivation only
Intervention Type
Behavioral
Intervention Name(s)
Exercise Plus Program (exercise + motivation)
Other Intervention Name(s)
Exercise, Motivation
Intervention Description
Exercise plus motivation
Primary Outcome Measure Information:
Title
Self-efficacy
Time Frame
2, 6, and 12 months post hip fracture
Title
Exercise behavior and activity
Time Frame
2, 6, and 12 months post hip fracture
Title
Subjective report of exercise
Time Frame
2, 6, and 12 months post hip fracture
Secondary Outcome Measure Information:
Title
Falls
Time Frame
2, 6, and 12 months post hip fracture
Title
Fall-related injuries
Time Frame
2, 6, and 12 months post hip fracture
Title
Fear of falling
Time Frame
2, 6, and 12 months post hip fracture
Title
Pain
Time Frame
2, 6, and 12 months post hip fracture
Title
36-item short-form health survey (SF-36)
Time Frame
2, 6, and 12 months post hip fracture
Title
Depression
Time Frame
2, 6, and 12 months post hip fracture
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Magaziner, Ph.D., MSHyg
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Baltimore Medical Center (GBMC)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Franklin Square Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
North Arundel Hospital
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36070134
Citation
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Results Reference
derived
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BHS5 - Testing the Effectiveness of the Exercise Plus Program
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