Clinical trial NCT00226070: Rehabilitation to Patients Over 65 Years Undergoing THA
Official title: Cross-section Study Among Patients Waiting for or Already Undergoing THA Followed by a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hip Arthroplasty
Keywords: selfrated health,
SF-36,
rehabilitation,
total hip replacement,
patients above 65
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients over 65 years do not have a self care ability the surgery benefits them.

The aim of this study is development of a rehabilitation program based on patients' self-rated health.

1. A cross section study including 600 patients
2. RCT including 160 patients

Detailed description: Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population.

Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program.

Eligibility criteria: Inclusion Criteria:patients over 65 years undergoing total hip replacement

-

Exclusion Criteria:

* patients dropping out

Primary outcomes:
measure: Selfrated health among the population shows significant dysfunction among patients over 75 years, patient living alone and patients depended on help from others
Secondary outcomes:
measure: undergoing
measure: we know next year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Kjeld Soballe, Orthopaedic center, University of Aarhus
city: Aarhus
country: Denmark
facility: Kjeld Soballe, Orthopaedic Center
city: Aarhus
country: Denmark
facility: Orthopaedic Center
city: Aarhus
country: Denmark
facility: Ortopaedic center, Aarhus University
city: Aarhus
country: Denmark
facility: University of Aarhus, Faculty of Health Sciences, Orthopaedic center
Study officials:
affiliation: Ortopaedic Center, Aarhus University Hospital, Aarhus Denmark
name: Kjeld Soballe, MD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedics, Aarhus University Hospital, Tage Hansensgade 10, DK-8000 Aarhus C
name: Kjeld Soballe
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospitak,Ortopaedic center, Aarhus Denmark
name: Kjeld Soballe, MD,DR.Med.,Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hordam B, Sabroe S, Pedersen PU, Mejdahl S, Soballe K. Nursing intervention by telephone interviews of patients aged over 65 years after total hip replacement improves health status: a randomised clinical trial. Scand J Caring Sci. 2010 Mar;24(1):94-100. doi: 10.1111/j.1471-6712.2009.00691.x. Epub 2009 Apr 28.