NCT00459966

Brief Summary

Aim: The aim is to evaluate the outcome after spine surgery when using an integrated program that combined preoperative prevention and early postoperative rehabilitation compared to the routine procedures. Outcome measurements: Postoperative hospital stay, complications, function, pain, and patient satisfaction. Method: 60 patients scheduled for surgery for degenerative lumbar disease. The control group followed the routines in the department. The intervention group followed the integrated program consisting of preoperative prevention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
Last Updated

April 13, 2007

Status Verified

April 1, 2007

First QC Date

April 11, 2007

Last Update Submit

April 12, 2007

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • hospital discharge

Interventions

Preoperative rehabilitationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Degenerative lumbar disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Head-Ortho-Centre, Anesthesiology Department, Rigshospitalet,

Copenhagen, dk-2100, Denmark

Location

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Per Rotboell Nielsen, MD

    uaffiliatation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

February 1, 2005

Study Completion

November 1, 2006

Last Updated

April 13, 2007

Record last verified: 2007-04

Locations

DK(1)