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Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02498093
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE July 15, 2015
Last Update Posted Date March 15, 2018
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Muscular strength [ Time Frame: 3 months ]
    leg press (kg), abduction (kg)
  • Muscular strength [ Time Frame: 6 months ]
    leg press (kg), abduction (kg)
  • muscular strength [ Time Frame: 1 year ]
    leg press (kg), abduction (kg)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02498093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Physical function [ Time Frame: up to 1 year ]
    Harris hip score, 6 min walking test
  • Bone mineral density [ Time Frame: up to 1 year ]
    Dual X-ray absorptiometry (DXA)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty
Official Title  ICMJE Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training
Brief Summary Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Muscle Weakness
Intervention  ICMJE
  • Behavioral: Maximal strength training
  • Behavioral: conventional rehabilitation
Study Arms  ICMJE
  • Experimental: Maximal strength training
    Maximal strength training supervised by a physiotherapist
    Intervention: Behavioral: Maximal strength training
  • Active Comparator: Control
    Conventional rehabilitation supervised by a physiotherapist
    Intervention: Behavioral: conventional rehabilitation
Publications * Kjesbu IE, Laursen CB, Graven T, Holden HM, Rømo B, Newton Andersen G, Mjølstad OC, Lassen A, Dalen H. Feasibility and Diagnostic Accuracy of Point-of-Care Abdominal Sonography by Pocket-Sized Imaging Devices, Performed by Medical Residents. J Ultrasound Med. 2017 Jun;36(6):1195-1202. doi: 10.7863/ultra.16.05077. Epub 2017 Feb 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
50
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • scheduled for total hip arthroplasty (THA)
  • living nearby Trondheim
  • diagnosis of primary osteoarthritis as the main cause for elective THA
  • ASA score of I-III (stable)

Exclusion Criteria:

  • muscular or skeletal disease which might influence the training and/or physical testing performance
  • communication difficulties
  • postoperatively discharged to a rehabilitation institution
  • THA in the bilateral hip that is not fully rehabilitated.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02498093
Other Study ID Numbers  ICMJE 2010/3373
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Lars Jacob Stovner, prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP