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Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty

Primary Purpose

Muscle Weakness

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 Muscle Weakness focused on measuring Resistance training, Arthroplasty, Replacement, Hip, Professional-Patient Relations, Evidence-based practice

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neuroscience, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maximal strength training

Control

Arm Description

Maximal strength training supervised by a physiotherapist

Conventional rehabilitation supervised by a physiotherapist

Outcomes

Primary Outcome Measures

Muscular strength
leg press (kg), abduction (kg)
Muscular strength
leg press (kg), abduction (kg)
muscular strength
leg press (kg), abduction (kg)

Secondary Outcome Measures

Physical function
Harris hip score, 6 min walking test
Bone mineral density
Dual X-ray absorptiometry (DXA)

Full Information

First Posted
July 8, 2015
Last Updated
April 20, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02498093
Brief Title
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty
Official Title
Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty: Implementing Evidence Based Rehabilitation Into Clinical Practice, and the Influence of Supervised Training
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Resistance training, Arthroplasty, Replacement, Hip, Professional-Patient Relations, Evidence-based practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maximal strength training
Arm Type
Experimental
Arm Description
Maximal strength training supervised by a physiotherapist
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation supervised by a physiotherapist
Intervention Type
Behavioral
Intervention Name(s)
Maximal strength training
Intervention Type
Behavioral
Intervention Name(s)
conventional rehabilitation
Primary Outcome Measure Information:
Title
Muscular strength
Description
leg press (kg), abduction (kg)
Time Frame
3 months
Title
Muscular strength
Description
leg press (kg), abduction (kg)
Time Frame
6 months
Title
muscular strength
Description
leg press (kg), abduction (kg)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Physical function
Description
Harris hip score, 6 min walking test
Time Frame
up to 1 year
Title
Bone mineral density
Description
Dual X-ray absorptiometry (DXA)
Time Frame
up to 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Jacob Stovner, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neuroscience, Faculty of Medicine
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32301372
Citation
Winther SB, Foss OA, Klaksvik J, Husby VS. Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients. J Orthop Surg (Hong Kong). 2020 Jan-Apr;28(2):2309499020916392. doi: 10.1177/2309499020916392.
Results Reference
result
PubMed Identifier
29493347
Citation
Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. A randomized controlled trial on maximal strength training in 60 patients undergoing total hip arthroplasty. Acta Orthop. 2018 Jun;89(3):295-301. doi: 10.1080/17453674.2018.1441362. Epub 2018 Mar 1.
Results Reference
result

Learn more about this trial

Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty

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