Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133640
Status:
UNKNOWN
Last Update Posted:
2006-09-11
First Post:
2005-08-22
Brief Title:
Early Rehabilitation After Hip Fracture
Sponsor:
Swiss National Science Foundation
Organization:
Swiss National Science Foundation
Study Overview
Official Title:
Early Rehabilitation After Hip Fracture A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs
Status:
UNKNOWN
Status Verified Date:
2006-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NFP 53-405340-104845 | None | None | None |