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Hip FractureHip5NCT00389844

BHS5 - Testing the Effectiveness of the Exercise Plus Program

A study testing Exercise Trainer component of the Exercise Plus Program, Plus component (motivation) of the Exercise Plus Program and Exercise Plus Program (exercise + motivation) in people with Hip Fracture, run by University of Maryland, Baltimore at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Hip Fracture
What is being tested?
Exercise Trainer component of the Exercise Plus Program, Plus component (motivation) of the Exercise Plus Program and Exercise Plus Program (exercise + motivation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
5 sitesUnited States
Study dates
Jul 2000to Sep 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Hip fracture

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Greater Baltimore Medical Center (GBMC)

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21225

  • St. Agnes Hospital

    Baltimore, Maryland, 21229

  • Franklin Square Hospital

    Baltimore, Maryland, 21237

  • North Arundel Hospital

    Glen Burnie, Maryland, 21061

Other trials in United States

About this study

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

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.

Read the 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
Hip Fracture
Being tested
Exercise Trainer component of the Exercise Plus Program, Plus component (motivation) of the Exercise Plus Program, Exercise Plus Program (exercise + motivation)
Keywords
hip fracture, exercise, motivation
Medical subject headings
Hip Fractures, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise Trainer component of the Exercise Plus ProgramBehavioural

    Also called Exercise

    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.

  • Plus component (motivation) of the Exercise Plus ProgramBehavioural

    Also called Motivation

    Motivation only

  • Exercise Plus Program (exercise + motivation)Behavioural

    Also called Exercise, Motivation

    Exercise plus motivation

Study groups in NCT00389844
Study groupRoleWhat they receive
1No interventionRoutine care
2Active comparatorExercise only
Receives: Behavioral: Exercise Trainer component of the Exercise Plus Program
3Active comparatorMotivation only
Receives: Behavioral: Exercise Trainer component of the Exercise Plus Program; Behavioral: Plus component (motivation) of the Exercise Plus Program
4ExperimentalExercise plus motivation
Receives: Behavioral: Exercise Trainer component of the Exercise Plus Program; Behavioral: Plus component (motivation) of the Exercise Plus Program; Behavioral: Exercise Plus Program (exercise + motivation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-efficacy

    Measured: 2, 6, and 12 months post hip fracture

  2. Exercise behavior and activity

    Measured: 2, 6, and 12 months post hip fracture

  3. Subjective report of exercise

    Measured: 2, 6, and 12 months post hip fracture

Secondary outcomes (6)

  1. Falls

    Measured: 2, 6, and 12 months post hip fracture

  2. Fall-related injuries

    Measured: 2, 6, and 12 months post hip fracture

  3. Fear of falling

    Measured: 2, 6, and 12 months post hip fracture

  4. Pain

    Measured: 2, 6, and 12 months post hip fracture

  5. 36-item short-form health survey (SF-36)

    Measured: 2, 6, and 12 months post hip fracture

  6. Depression

    Measured: 2, 6, and 12 months post hip fracture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study startJul 2000
  3. Primary completionSep 2004
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Investigator
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389844
Sponsor's protocol ID
H-22361
Other IDs
5R01AG017082-04
Acronym
Hip5
Status last verified
Mar 2022
First submitted
18 Oct 2006
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36070134

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Trainer component of the Exercise Plus Program, Plus component (motivation) of the Exercise Plus Program and Exercise Plus Program (exercise + motivation) in people with Hip Fracture, run by University of Maryland, Baltimore at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy (time frame: 2, 6, and 12 months post hip fracture). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389844, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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