NCT00493142

Brief Summary

The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 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

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

5 years

First QC Date

June 26, 2007

Last Update Submit

July 13, 2022

Conditions

OsteoarthritisRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Self-reported function

    Self-reported function

    5 evaluations within 6 months after surgery

Secondary Outcomes (5)

  • Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction

    5 evaluations within 6 months after surgery

  • self-efficacy

    5 evaluations within 6 months after surgery

  • ambulation, anxiety and patient satisfaction

    5 evaluations within 6 months after surgery

  • anxiety

    5 evaluations within 6 months after surgery

  • patient satisfaction

    5 evaluations within 6 months after surgery

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care

Other: Usual care

Exercise

EXPERIMENTAL

Exercise

Other: Exercise

Interventions

ExerciseOTHER
Exercise
Usual careOTHER
Usual care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary unilateral total knee arthroplasty
  • poor functional status (WOMAC=50 or greater)
  • yrs or older
  • reside within health region
  • understands English

You may not qualify if:

  • unicompartmental total knee arthroplasty
  • revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta- Capital Health

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Allyson Jones, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Lauren Beaupre, PhD

    Capital Health- UAH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

July 1, 2008

Primary Completion

July 1, 2013

Study Completion

November 25, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CA(1)