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Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Maximal strength training
conventional rehabilitation
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary osteoarthritis
  • Unilateral osteoarthritis
  • Age below 65 yrs
  • ASA group 1-2

Exclusion Criteria:

  • Pregnancy
  • Age below 18 yrs
  • Cardiovascular disease
  • Diseases in the musculoskeletal system that could influence on training

Sites / Locations

  • Faculty of Medicine, NTNU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

maximal strength training

conventional rehabilitation

Arm Description

maximal dynamic strength training

rehabilitation as usual

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 12, 2008
Last Updated
March 9, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
OrtoMedic A/S, Oslo, Scandinavian Customized Prosthesis (SCP)
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1. Study Identification

Unique Protocol Identification Number
NCT00638417
Brief Title
Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
Official Title
Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2006 (Actual)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
OrtoMedic A/S, Oslo, Scandinavian Customized Prosthesis (SCP)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to improve hospital treatment and rehabilitation of patients with hip arthroplasty to help the patients to regain functional ability in the shortest possible time, and reduce hospital and rehabilitation time to save costs for the patient and society. Optimal reconstruction of the hip joint and the effect of an intensive physical training programme are compared to conventional rehabilitation programmes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
maximal strength training
Arm Type
Experimental
Arm Description
maximal dynamic strength training
Arm Title
conventional rehabilitation
Arm Type
Other
Arm Description
rehabilitation as usual
Intervention Type
Behavioral
Intervention Name(s)
Maximal strength training
Intervention Description
maximal dynamic strength training from 1 week after the operation, 5 training bouts a week for 4 weeks. The regimen consisted of 2 exercises, leg press and hip abduction, that included 4 series of 5RM involving the operated leg only. 5RM corresponds to approximately 85% of 1RM. When the patients managed to perform 6RM, the load was increased by 5kg. The series were separated by resting periods of 2 minutes.
Intervention Type
Behavioral
Intervention Name(s)
conventional rehabilitation
Intervention Description
conventional rehabilitation program: inpatient treatment in a rehabilitation center. Individual sling exercise therapy in hip abduction/adduction, hip flexion/extension, exercises with low resistance (>12-15 repetitions37), or no resistance and exercises performed in water when sutures had been removed. Each session lasted 1 hour and was performed 5 days a week for 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary osteoarthritis Unilateral osteoarthritis Age below 65 yrs ASA group 1-2 Exclusion Criteria: Pregnancy Age below 18 yrs Cardiovascular disease Diseases in the musculoskeletal system that could influence on training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hoff, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, NTNU
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
19801053
Citation
Husby VS, Helgerud J, Bjorgen S, Husby OS, Benum P, Hoff J. Early maximal strength training is an efficient treatment for patients operated with total hip arthroplasty. Arch Phys Med Rehabil. 2009 Oct;90(10):1658-67. doi: 10.1016/j.apmr.2009.04.018.
Results Reference
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Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life

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