Contact information
Type
Scientific
Primary contact
Dr Ingemar Petersson
ORCID ID
Contact details
Spenshult Hospital for Rheumatic Diseases
Oskarström
S-313 92
Sweden
ingemar.petersson@spenshult.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Short-term high-intensity exercise improves self-reported pain, function and quality of life in middle-aged patients with moderate to severe knee osteoarthritis.
Ethics approval
The study was approved by the Research Ethics Committee at Lund University (Sweden) (ref: LU 99-98), and is in compliance with the Helsinki Declaration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Knee osteoarthritis
Intervention
A six-week high-intensity supervised exercise session twice a week, or a non-intervention control group.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Knee injury and Osteoarthritis Outcome Score (KOOS, a disease specific questionnaire, assessing pain, other symptoms, activities of daily living, sport and recreation function and knee-related quality of life). Time points of interest were 6 weeks and 6 months.
Secondary outcome measures
1. 36-item short form health survey (SF-36, a generic measure of general health status)
2. Five tests of functional performance:
2.1. Åstrands bicycle-ergometre test
2.2. Rising on one leg from sitting on lowest possible height
2.3. One-leg hop
2.4. Lateral step-up
2.5. One-leg semi squatting
2.6. Heel-rising on one leg
Overall trial start date
09/10/1998
Overall trial end date
08/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 35 - 65 years
2. Living in a defined geographic area
3. Diagnosis of radiographic knee osteoarthritis according to Kellgren & Lawrence grade III or more (i.e joint space narrowing and definite osteophytes)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
61
Participant exclusion criteria
1. Inflammatory joint disease
2. Anterior cruciate ligament injury
3. Known symptomatic injury to the menisci
4. Hip symptoms more aggravating than the knee symptoms
5. About to have knee replacement surgery within 6 months
6. Co-morbidities not allowing exercise
Recruitment start date
09/10/1998
Recruitment end date
08/10/2001
Locations
Countries of recruitment
Sweden
Trial participating centre
Spenshult Hospital for Rheumatic Diseases
Oskarström
S-313 92
Sweden
Sponsor information
Organisation
The Swedish Rheumatism Association (Sweden)
Sponsor details
Alströmergatan 39
Box 12851
Stockholm
S-112 98
Sweden
jan.bagge@reumatikerforbundet.se
Sponsor type
Charity
Website
Funders
Funder type
Research organisation
Funder name
The Vårdal Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedish Rheumatism Association in Stockholm (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedish Rheumatism Association in Gothenburgh (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedish Research Council (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Department of Research and Development at Spenshult Hospital for Rheumatic Diseases (Sweden)
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
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15924620
Publication citations
-
Results
Thorstensson CA, Roos EM, Petersson IF, Ekdahl C, Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial [ISRCTN20244858]., BMC Musculoskelet Disord, 2005, 6, 27, doi: 10.1186/1471-2474-6-27.