Early Rehabilitation After Hip Fracture
Recruitment status was Recruiting
|First Received Date ICMJE||August 22, 2005|
|Last Updated Date||September 7, 2006|
|Start Date ICMJE||January 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||rate of falls compared between treatment arms|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00133640 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Early Rehabilitation After Hip Fracture|
|Official Title ICMJE||Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||December 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||65 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Switzerland|
|NCT Number ICMJE||NCT00133640|
|Other Study ID Numbers ICMJE||405340-104845, NFP 53-405340-104845|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Swiss National Science Foundation|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Swiss National Science Foundation|
|Verification Date||August 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP