Condition category
Signs and Symptoms
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
01/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laurence Wood

ORCID ID

Contact details

Primary Care Musculoskeletal Research Centre
Keele
Newcastle
ST5 5BG
United Kingdom
+44 1782 733908
l.r.j.wood@cphc.keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5142

Study information

Scientific title

Individualising exercise for knee pain: developing an evidence-based impairment-targeted intervention

Acronym

TargET-Knee-Pain

Study hypothesis

The overall aim of this study is to investigate the principle of impairment-targeted exercises as treatments for older adults with knee pain. The study has a single-group design. It has the following objectives:

Objective 1:
To test the proof-of-principle that simple home-based impairment-targeted exercises can improve those impairments in older adults with knee pain.

Objective 2:
To investigate whether improvements in these impairments are reflected in improvements in self-reports of physical function.

Objective 3:
To assess the feasibility of this intervention approach and its acceptability to patients by qualitative means.

Ethics approval

MREC approved on the 7th November 2008 (ref: 08/H1202/179)

Study design

Single centre non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Primary Care Research Network for England, Musculoskeletal; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases

Intervention

This will be a single-centre study. Participants will be invited to participate in the current study at the end of their visit for final clinical assessment before the termination of the CAS-K study.

Exercise programme: consists of an individualised home-based impairment-targeted exercise programme for 12 weeks (fortnightly home visits alternating with fortnightly telephone calls) and involves daily self-directed formal exercises.

Recruitment will last for the duration of the final clinical assessment clinics, which are planned to take place between January and December 2009. Duration of follow-up will be 12 weeks.

Study entry: registration only

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Degree of knee flexion, measured with a continuous scale outcome

Secondary outcome measures

1. Isometric quadriceps strength at 90º flexion, measured with a continuous scale outcome
2. The four-test balance scale, measured with an ordinal scale (range 0 - 5), including feet together stand, semi-tandem stand, tandem stand and one-leg stand

Overall trial start date

05/05/2009

Overall trial end date

09/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 56 years and older, either sex
2. A history of painful osteoarthritis of the knees
3. One or more of the target impairments
4. Recruited from the longitudinal population-based Clinical Assessment Study of the Knee (CAS-K)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 80; UK sample size: 80

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

05/05/2009

Recruitment end date

09/02/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Musculoskeletal Research Centre
Newcastle
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-10612)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21214901
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26821917

Publication citations

  1. Results

    Wood LR, Peat GM, Mullis R, Thomas E, Foster NE, Impairment-targeted exercises for older adults with knee pain: protocol for a proof-of-principle study., BMC Musculoskelet Disord, 2011, 12, 2, doi: 10.1186/1471-2474-12-2.

Additional files

Editorial Notes

01/02/2016: Publication reference added, verifying study status with principal investigator.