BHS4 - Bone/Muscle Changes Following Hip Fracture in Older White Women

NCT00390741 | Completed DMC

• 2 other identifiers: H-20834NIA R37 AG09901
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

The major goals of this study are:

1. 1.To conduct an intervention development study to evaluate the feasibility of implementing an exercise intervention for reduction losses in bone mineral density, muscle mass, and strength, and clinically relevant aspects of functioning following a hip fracture, and to obtain preliminary tests of the effective ness of these interventions.
2. 2.To evaluate the effect of home-based exercise intervention on bone metabolism.
3. 3.To evaluate the effects of hip fracture on bone metabolism.
4. 4.To evaluate the effects of exercise and hip fracture on hormonal regulators.
5. 5.To evaluate the association between markers of bone metabolism hormone regulators, and BMD.
6. 6.To separate out the effects of hip fracture on bone turnover from those of aging in persons with low bone mineral density.

Conditions

Hip Fracture

Keywords

hip fracture; bone mineral density; exercise

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 reporting of exercise

  2, 6, and 12 months post hip fracture

Secondary Outcomes (6)

• Compliance

  2, 6, and 12 months post hip fracture

• Change in BMD

  2, 6, and 12 months post hip fracture

• Lower extremity function

  2, 6, and 12 months post hip fracture

• Falls

  2, 6, and 12 months post hip fracture

• Time to weight bearing

  2, 6, and 12 months post hip fracture

Study Arms (2)

1

ACTIVE COMPARATOR

Home-based exercise program

Behavioral: Exercise Plus Program

2

NO INTERVENTION

Usual care

Interventions

Exercise Plus Program BEHAVIORAL

Those assigned to the treatment group were visited by an exercise trainer three times a week for the first two months of the study, two times per week during months three and four, one time per week during months five and six, two times a month during months seven and eight, and one time a month during months nine through twelve. During months seven through twelve of the study the trainer contacted the participant by telephone once each week during the weeks that he or she did not go the participants' home.

Also known as: Exercise

1

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-surgical repair of hip fracture
• Non-community dwelling
• Fractured more than 72 hours before admission to the hospital
• Pathologic fracture
• Resides more than 70 miles 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 equal heart less than 60 or greater than 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 greater than 180 mm Hg or resting diastolic greater than 100 mm Hg (3 or more readings with 24- hour period)
• Presence of ventricular aneurysm

Sponsors & Collaborators

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

Study Sites (3)

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Northwest Hospital Center

Randallstown, Maryland, 21133, United States

Location

St. Joseph's Hospital

Towson, Maryland, 21204, United States

Location

Related Publications (1)

• Orwig DL, Hochberg M, Yu-Yahiro J, Resnick B, Hawkes WG, Shardell M, Hebel JR, Colvin P, Miller RR, Golden J, Zimmerman S, Magaziner J. Delivery and outcomes of a yearlong home exercise program after hip fracture: a randomized controlled trial. Arch Intern Med. 2011 Feb 28;171(4):323-31. doi: 10.1001/archinternmed.2011.15.

  PMID: 21357809 DERIVED

MeSH Terms

Conditions

Hip Fractures; Motor Activity

Interventions

Exercise

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

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: PARALLEL
• 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 20, 2006
• Study Start: October 1, 1998
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2005
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

US (3)