Early Rehabilitation After Hip Fracture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Swiss National Science Foundation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Swiss National Science Foundation
ClinicalTrials.gov Identifier:
NCT00133640
First received: August 22, 2005
Last updated: September 7, 2006
Last verified: August 2006
  Purpose

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 Intervention Phase
Accidental Falls
Fractures
Hip Fractures
Drug: cholecalciferol
Behavioral: Physiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs

Resource links provided by NLM:


Further study details as provided by Swiss National Science Foundation:

Primary Outcome Measures:
  • rate of falls compared between treatment arms

Secondary Outcome Measures:
  • rate of 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
  • health care utilization
  • admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture

Estimated Enrollment: 204
Study Start Date: January 2005
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133640

Contacts
Contact: Heike A Bischoff-Ferrari, MD, MPH +41-44-2552699 Heike.Bischoff@usz.ch

Locations
Switzerland
Triemli Hospital Recruiting
Zurich, Switzerland, 8063
Contact: Heike A Bischoff-Ferrari, MD, MPH    +41-44-2552699    HeikeBischoff@usz.ch   
Principal Investigator: Robert Theiler, MD         
Sponsors and Collaborators
Swiss National Science Foundation
Investigators
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
  More Information

No publications provided by Swiss National Science Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00133640     History of Changes
Other Study ID Numbers: 405340-104845, NFP 53-405340-104845
Study First Received: August 22, 2005
Last Updated: September 7, 2006
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss National Science Foundation:
Vitamin D
Elderly
Hip fracture
Falls
Physical Therapy
Disability

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Hip Injuries
Leg Injuries
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014