Early Rehabilitation After Hip Fracture
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|ClinicalTrials.gov Identifier: NCT00133640|
Recruitment Status : Unknown
Verified August 2006 by Swiss National Science Foundation.
Recruitment status was: Recruiting
First Posted : August 23, 2005
Last Update Posted : September 11, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls Fractures Hip Fractures||Drug: cholecalciferol Behavioral: Physiotherapy||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs|
|Study Start Date :||January 2005|
|Estimated Study Completion Date :||December 2008|
- rate of falls compared between treatment arms
- rate of injurious falls
- number of persons who fell
- low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia)
- quality of life (Euro-Qol)
- health care utilization
- admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133640
|Contact: Heike A Bischoff-Ferrari, MD, MPH||+41-44-2552699||Heike.Bischoff@usz.ch|
|Zurich, Switzerland, 8063|
|Contact: Heike A Bischoff-Ferrari, MD, MPH +41-44-2552699 HeikeBischoff@usz.ch|
|Principal Investigator: Robert Theiler, MD|
|Principal Investigator:||Heike A Bischoff-Ferrari, MD, MPH||University of Zurich|
|Study Director:||Robert Theiler, MD||Triemli Spital Zurich|
|Study Chair:||Hannes B Staehelin, MD||University of Basel|
|Study Director:||Andreas Platz, MD||TriemliSpital|