NCT01683201

Brief Summary

The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

September 7, 2012

Last Update Submit

March 18, 2015

Conditions

Keywords

Total hip replacementFunctional exercise classRandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • WOMAC Western Ontario and Mc Master osteoarthritis index questionaire

    Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.

    3 YEARS

Secondary Outcomes (4)

  • Six minute walk test,

    3 years

  • Short form SF- 12

    3 YEARS

  • HiP Abduction Strength Dynamometry

    3 years

  • Real time ultrasound imaging of the gluteus medius muscles

    3 years

Study Arms (2)

Functional exercise class

EXPERIMENTAL

Functional exercise class 45 mins twice weekly from week 12 to week 18

Procedure: Functional exercise class

Usual Care Group

PLACEBO COMPARATOR

Usual Care

Procedure: usual care group

Interventions

Functional exercise class running twice weekly for six weeks from week 12 to week 18

Functional exercise class

Usual care group adhere to post operative instructions given on discharge from hospital

Usual Care Group

Eligibility Criteria

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

You may qualify if:

  • weeks post primary THR for osteoarthritis
  • Age 50 years and above
  • Able to read and understand and instructions in English
  • Willing to attend classes twice weekly for 8 weeks
  • Able to participate in an exercise programme without physical assistance

You may not qualify if:

  • Medically unstable
  • Any central or peripheral nervous system deficits
  • Any underlying terminal disease -Any suspicion of infection following joint replacement -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Monaghan B, Cunningham P, Harrington P, Hing W, Blake C, O' Dohertya D, Cusack T. Randomised controlled trial to evaluate a physiotherapy-led functional exercise programme after total hip replacement. Physiotherapy. 2017 Sep;103(3):283-288. doi: 10.1016/j.physio.2016.01.003. Epub 2016 Feb 15.

  • Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237.

Study Officials

  • Brenda M Monaghan, BSc, MSc

    HSE Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Clinical Specialist Physiotherapist

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

February 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03