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Early Rehabilitation After Hip Fracture

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Swiss National Science Foundation.
Recruitment status was:  Recruiting
Information provided by:
Swiss National Science Foundation Identifier:
First received: August 22, 2005
Last updated: September 7, 2006
Last verified: August 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 Intervention Phase
Accidental Falls
Hip Fractures
Drug: cholecalciferol
Behavioral: Physiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00133640

Contact: Heike A Bischoff-Ferrari, MD, MPH +41-44-2552699

Triemli Hospital Recruiting
Zurich, Switzerland, 8063
Contact: Heike A Bischoff-Ferrari, MD, MPH    +41-44-2552699   
Principal Investigator: Robert Theiler, MD         
Sponsors and Collaborators
Swiss National Science Foundation
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

Publications automatically indexed to this study by Identifier (NCT Number): 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

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

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017