BHS5 - Testing the Effectiveness of the Exercise Plus Program

NCT00389844 | Completed DMC

• 2 other identifiers: H-223615R01AG017082-04
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

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.

Conditions

Hip Fracture

Keywords

hip fracture; exercise; motivation

Outcome Measures

Primary Outcomes (3)

• Self-efficacy

  2, 6, and 12 months post hip fracture

• Exercise behavior and activity

  2, 6, and 12 months post hip fracture

• Subjective report of exercise

  2, 6, and 12 months post hip fracture

Secondary Outcomes (6)

• Falls

  2, 6, and 12 months post hip fracture

• Fall-related injuries

  2, 6, and 12 months post hip fracture

• Fear of falling

  2, 6, and 12 months post hip fracture

• Pain

  2, 6, and 12 months post hip fracture

• 36-item short-form health survey (SF-36)

  2, 6, and 12 months post hip fracture

Study Arms (4)

1

NO INTERVENTION

Routine care

2

ACTIVE COMPARATOR

Exercise only

Behavioral: Exercise Trainer component of the Exercise Plus Program

3

ACTIVE COMPARATOR

Motivation only

Behavioral: Exercise Trainer component of the Exercise Plus Program; Behavioral: Plus component (motivation) of the Exercise Plus Program

4

EXPERIMENTAL

Exercise plus motivation

Behavioral: Exercise Trainer component of the Exercise Plus Program; Behavioral: Plus component (motivation) of the Exercise Plus Program; Behavioral: Exercise Plus Program (exercise + motivation)

Interventions

Exercise Trainer component of the Exercise Plus Program BEHAVIORAL

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.

Also known as: Exercise

2; 3; 4

Plus component (motivation) of the Exercise Plus Program BEHAVIORAL

Motivation only

Also known as: Motivation

3; 4

Exercise Plus Program (exercise + motivation) BEHAVIORAL

Exercise plus motivation

Also known as: Exercise, Motivation

4

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hip fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (5)

Greater Baltimore Medical Center (GBMC)

Baltimore, Maryland, 21204, United States

Location

Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

St. Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Franklin Square Hospital

Baltimore, Maryland, 21237, United States

Location

North Arundel Hospital

Glen Burnie, Maryland, 21061, United States

Location

Related Publications (1)

• 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.

  PMID: 36070134 DERIVED

MeSH Terms

Conditions

Hip Fractures; Motor Activity

Interventions

Exercise; Elements; Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Inorganic Chemicals; Models, Psychological; Models, Theoretical; Investigative Techniques

Study Officials

• Jay Magaziner, Ph.D., MSHyg

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department Of Epidemiology & Public Health; Director, Center For Research On Aging

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: July 1, 2000
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2005
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

US (5)