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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21214901
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26821917
Publication citations
-
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.