Early Rehabilitation After Hip Fracture

Sponsor

Swiss National Science Foundation (Other)

Overall Status

Unknown status

CT.gov ID

NCT00133640

Collaborator

(none)

204

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Accidental Falls Fractures Hip Fractures	Drug: cholecalciferol Behavioral: Physiotherapy	Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs

Study Start Date :

Jan 1, 2005

Study Completion Date :

Dec 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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