NCT02636751

Brief Summary

This pilot single blind randomized controlled trial aims therefore to evaluate the feasibility and the impact on pain and disabilities of a telerehabilitation prehabilitation program for patients awaiting a total joint (hip or knee) arthroplasty compared to in-person prehabilitation or to usual care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

December 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

December 14, 2015

Last Update Submit

July 1, 2016

Conditions

Osteoarthritis

Keywords

PrehabilitationTelemedicineOsteoarthritisArthroplastyHipKnee

Outcome Measures

Primary Outcomes (1)

  • Change in Lower Extremity Functional Scale (LEFS)

    20-item questionnaire. Each item is rated on a five-point scale (0= extreme difficulty or unable to perform activity, 4= no difficulty); total scores range from 0 to 80, and lower scores represent greater difficulty.

    At Baseline and 12 weeks after baseline

Secondary Outcomes (7)

  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    At Baseline and 12 weeks after baseline

  • Change in Short Form (36) Health Survey

    At Baseline and 12 weeks after baseline

  • Change in Global Rating of Change scale (GRC)

    At Baseline and 12 weeks after baseline

  • Change in Timed Up and Go (TUG)

    At Baseline and 12 weeks after baseline

  • Change in StairTest (ST)

    At Baseline and 12 weeks after baseline

  • +2 more secondary outcomes

Study Arms (3)

In-person prehabilitation group

EXPERIMENTAL

The participants in this group will receive a 12-week rehabilitation program (2x/week) including, education, stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities, in addition to walking aid adjustment. General information about pain control, such as ice application and medication usage will also be provided

Behavioral: 12-week prehabilitation programDevice: Walking aid adjustmentBehavioral: Information about pain control

Tele-prehabilitation group

EXPERIMENTAL

The participants in this group will receive a 12-week rehabilitation program (2x/week) including, education, stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities, in addition to walking aid adjustment using a telecommunication software (Reacts®, Facetime® or Skype®). General information about pain control, such as ice application and medication usage will also be provided.

Behavioral: 12-week prehabilitation programDevice: Walking aid adjustmentBehavioral: Information about pain control

Usual care group

ACTIVE COMPARATOR

The participants in this group will be provided with the hospital's usual documentation before total joint arthroplasties, consisting of information regarding the pre- and post-surgery course and medication.

Device: Walking aid adjustmentBehavioral: Information about pain control

Interventions

12-week prehabilitation programBEHAVIORAL

stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities

In-person prehabilitation groupTele-prehabilitation group
Walking aid adjustmentDEVICE

Walking aid adjustment

In-person prehabilitation groupTele-prehabilitation groupUsual care group
Information about pain controlBEHAVIORAL

General information about pain control, such as ice application and medication usage

In-person prehabilitation groupTele-prehabilitation groupUsual care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years;
  • Waiting for a TKA or a THA
  • Suffering from severe OA of hip or knee
  • Quebec resident covered by the Régie de l'assurance maladie du Québec (Quebec public healthcare insurance)
  • Speaks French
  • Has a high-speed internet connection.

You may not qualify if:

  • Suffering from inflammatory arthritis
  • Scheduled for a bilateral surgery
  • Has had a lower limb surgery in the past 6 months
  • Scheduled for a revision of a previous TKA or THA
  • Planned for a wide acetabular head hip prosthesis or a hip articular resurfacing
  • Receiving a compensation from Quebec Commission de la santé et de la sécurité du travail (government insurer for workers and employers)
  • Suffering from a severe psychiatric neurologic or cardiac disorder, or other types of disorders that could interfere with the rehabilitation program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS Centre-est-de-l'île-de-Montréal - Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Related Publications (2)

  • Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Feasibility and preliminary effects of a tele-prehabilitation program and an in-person prehablitation program compared to usual care for total hip or knee arthroplasty candidates: a pilot randomized controlled trial. Disabil Rehabil. 2020 Apr;42(7):989-998. doi: 10.1080/09638288.2018.1515992. Epub 2019 Jan 13.

    PMID: 30638076DERIVED

  • Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial. Contemp Clin Trials Commun. 2016 Oct 5;4:192-198. doi: 10.1016/j.conctc.2016.10.001. eCollection 2016 Dec 15.

    PMID: 29736482DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • François Desmeules, Ph.D.

    CIUSSS Centre-Est-de-l"île-de-Montréal, Installation Maisonneuve-Rosemont Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Doiron-Cadrin, B.Sc.

CONTACT

514-252-3400

Véronique Lowry, M.Sc.

CONTACT

514-252-3400

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Rehabilitation, University of Montreal

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 22, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

June 1, 2017

Last Updated

July 4, 2016

Record last verified: 2016-06

Locations

CA(1)