Early Rehabilitation After Hip Fracture

Hip Fractures Clinical Trial

Official title:

Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00133640
• Other study ID #: 405340-104845
• Secondary ID: NFP 53-405340-10
• Status: Recruiting
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: September 7, 2006
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2006
• Source: Swiss National Science Foundation
• Contact: Heike A Bischoff-Ferrari, MD, MPH
• Phone: +41-44-2552699
• Email: Heike.Bischoff[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.

The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.

Description:

Subjects:

The researchers will enroll 204 elderly subjects (men and women) admitted to two large hospital centers with acute hip fracture. Subjects may be institutionalized or community-dwelling prior to admission. To be enrolled in the study subjects need to be 65 years or older. Demented persons, who reach a Folstein Mini Mental Status of less than 15 are excluded.

Design:

Once written informed consent from participants or proxies is given, subjects will be randomly assigned to 4 different program combinations based on a 2X2 factorial design: (1) low dose vitamin D / low intensity physiotherapy; or (2) low dose vitamin D / high intensity physiotherapy; or (3) high dose vitamin D / low intensity physiotherapy; or (4) high dose vitamin D / high intensity physiotherapy. Low dose Vitamin D is 800 IU cholecalciferol per day and high dose vitamin D is 2000 IU cholecalciferol per day.

Subjects will be recruited within 5 days after hip fracture surgery and followed for adverse outcomes over a 12-month period. Dose of vitamin D will be double-blinded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65 years or older

• Acute hip fracture admitted to one hospital center

Exclusion Criteria:

• A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia

• Primary hyperparathyroidism

• Current cancer with wasting or bone metastases

• Hyperparathyroidism

• Sarcoidosis

• A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)

• Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l

• non-surgical treatment

• no German language skills

• severe hearing or visual impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls
• Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• cholecalciferol

Behavioral:
• Physiotherapy

Locations

Country	Name	City	State
Switzerland	Triemli Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of falls compared between treatment arms
Secondary	rate of injurious falls
Secondary	number of persons who fell
Secondary	low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia)
Secondary	disability
Secondary	quality of life (Euro-Qol)
Secondary	mortality
Secondary	health care utilization
Secondary	admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture