Clinical trial NCT00133640: Early Rehabilitation After Hip Fracture
Official title: Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Accidental Falls
Fractures
Hip Fractures
Keywords: Vitamin D
Elderly
Hip fracture
Falls
Physical Therapy
Disability
Lead sponsor: Swiss National Science Foundation
Sponsor class: OTHER
First posted: 2005-08-23
Enrollment: 204
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: rate of falls compared between treatment arms
Secondary outcomes:
measure: rate of injurious falls
measure: number of persons who fell
measure: low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia)
measure: disability
measure: quality of life (Euro-Qol)
measure: mortality
measure: health care utilization
measure: admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: University of Zurich
name: Heike A Bischoff-Ferrari, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Triemli Spital Zurich
name: Robert Theiler, MD
role: STUDY_DIRECTOR
affiliation: University of Basel
name: Hannes B Staehelin, MD
role: STUDY_CHAIR
affiliation: TriemliSpital
name: Andreas Platz, MD
role: STUDY_DIRECTOR
References:
citation: Fischer K, Trombik M, Freystatter G, Egli A, Theiler R, Bischoff-Ferrari HA. Timeline of functional recovery after hip fracture in seniors aged 65 and older: a prospective observational analysis. Osteoporos Int. 2019 Jul;30(7):1371-1381. doi: 10.1007/s00198-019-04944-5. Epub 2019 Apr 2.
citation: Nardi M, Fischer K, Dawson-Hughes B, Orav EJ, Meyer OW, Meyer U, Beck S, Simmen HP, Pape HC, Egli A, Willett WC, Theiler R, Bischoff-Ferrari HA. Association between Caregiver Role and Short- and Long-Term Functional Recovery after Hip Fracture: A Prospective Study. J Am Med Dir Assoc. 2018 Feb;19(2):122-129. doi: 10.1016/j.jamda.2017.08.009. Epub 2017 Sep 30.
citation: Schaller F, Sidelnikov E, Theiler R, Egli A, Staehelin HB, Dick W, Dawson-Hughes B, Grob D, Platz A, Can U, Bischoff-Ferrari HA. Mild to moderate cognitive impairment is a major risk factor for mortality and nursing home admission in the first year after hip fracture. Bone. 2012 Sep;51(3):347-52. doi: 10.1016/j.bone.2012.06.004. Epub 2012 Jun 12.
citation: Bischoff-Ferrari HA, Dawson-Hughes B, Platz A, Orav EJ, Stahelin HB, Willett WC, Can U, Egli A, Mueller NJ, Looser S, Bretscher B, Minder E, Vergopoulos A, Theiler R. Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial. Arch Intern Med. 2010 May 10;170(9):813-20. doi: 10.1001/archinternmed.2010.67.