NCT02498093

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.

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 Aug 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

July 8, 2015

Last Update Submit

April 20, 2020

Conditions

Muscle Weakness

Keywords

Resistance trainingArthroplasty, Replacement, HipProfessional-Patient RelationsEvidence-based practice

Outcome Measures

Primary Outcomes (3)

  • Muscular strength

    leg press (kg), abduction (kg)

    3 months

  • Muscular strength

    leg press (kg), abduction (kg)

    6 months

  • muscular strength

    leg press (kg), abduction (kg)

    1 year

Secondary Outcomes (2)

  • Physical function

    up to 1 year

  • Bone mineral density

    up to 1 year

Study Arms (2)

Maximal strength training

EXPERIMENTAL

Maximal strength training supervised by a physiotherapist

Behavioral: Maximal strength training

Control

ACTIVE COMPARATOR

Conventional rehabilitation supervised by a physiotherapist

Behavioral: conventional rehabilitation

Interventions

Maximal strength trainingBEHAVIORAL
Maximal strength training
conventional rehabilitationBEHAVIORAL
Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience, Faculty of Medicine

Trondheim, Norway

Location

Related Publications (2)

  • 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.

    PMID: 32301372RESULT

  • 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.

    PMID: 29493347RESULT

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Lars Jacob Stovner, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 15, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations

NO(1)