Early Rehabilitation After Hip Fracture

September 7, 2006 updated by: Swiss National Science Foundation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8063
        • Recruiting
        • Triemli Hospital
        • Contact:
        • Principal Investigator:
          • Robert Theiler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rate of falls compared between treatment arms

Secondary Outcome Measures

Outcome Measure
mortality
disability
health care utilization
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)
admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 23, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 405340-104845
  • NFP 53-405340-104845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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