Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristi E Heiberg, PhD, University of Oslo
ClinicalTrials.gov Identifier:
NCT00808483
First received: December 12, 2008
Last updated: January 8, 2015
Last verified: January 2015
Results First Received: December 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Arthroplasty, Replacement, Hip
Exercise Therapy
Intervention: Other: Walking skill training program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the hospital the day before surgery from October 2008 to March 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Walking Skill Training Group

12 sessions of participation in the walking skill training program.

Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.

Control Group No participation in the walking skill training group

Participant Flow for 2 periods

Period 1:   From 3 to 5 Months After Surgery
    Walking Skill Training Group     Control Group  
STARTED     35     33  
COMPLETED     33     32  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 1  
Lack of Efficacy                 1                 0  

Period 2:   From 5 Months to 12 Months
    Walking Skill Training Group     Control Group  
STARTED     33     32  
COMPLETED     32     32  
NOT COMPLETED     1     0  
Lack of Efficacy                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Walking Skill Training Group

12 sessions of participation in the walking skill training program.

Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist.

Control Group No participation in the walking skill training group
Total Total of all reporting groups

Baseline Measures
    Walking Skill Training Group     Control Group     Total  
Number of Participants  
[units: participants]
  35     33     68  
Age  
[units: years]
Mean (Full Range)
  65  
  (49 to 78)  
  66  
  (45 to 81)  
  66  
  (45 to 81)  
Gender  
[units: participants]
     
Female     21     14     35  
Male     14     19     33  
BMI  
[units: kg/m^2]
Mean (Full Range)
  27  
  (20 to 37)  
  27  
  (21 to 36)  
  27  
  (20 to 37)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   6 Minutes Walk Test (6MWT)   [ Time Frame: 5 months and 12 months ]

2.  Secondary:   Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)   [ Time Frame: 5 months and 12 months ]

3.  Secondary:   Harris Hip Score (HHS)   [ Time Frame: 5 months and 12 months ]

4.  Secondary:   Self-efficacy   [ Time Frame: 5 months and 12 months ]

5.  Secondary:   Stair Climbing Test (ST)   [ Time Frame: 5 months and 12 months ]

6.  Secondary:   ROM Extension   [ Time Frame: 5 months and 12 months ]

7.  Secondary:   Index of Muscle Function (IMF)   [ Time Frame: 5 months and 12 months ]

8.  Secondary:   Figure-of-eight Test   [ Time Frame: 5 months and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Anne Marit Mengshoel
Organization: University of Oslo
phone: 004790036933
e-mail: a.m.mengshoel@medisin.uio.no



Responsible Party: Kristi E Heiberg, PhD, University of Oslo
ClinicalTrials.gov Identifier: NCT00808483     History of Changes
Other Study ID Numbers: 2008/2325
Study First Received: December 12, 2008
Results First Received: December 9, 2014
Last Updated: January 8, 2015
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics