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Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial
ISRCTN ISRCTN20244858
DOI 10.1186/ISRCTN20244858
ClinicalTrials.gov identifier
EudraCT number
Public title Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial
Scientific title
Acronym N/A
Serial number at source N/A
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.
Lay summary
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
Countries of recruitment Sweden
Disease/condition/study domain Knee osteoarthritis
Participants - 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)
Participants - 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
Anticipated start date 09/10/1998
Anticipated end date 08/10/2001
Status of trial Completed
Patient information material
Target number of participants 61
Interventions A six-week high-intensity supervised exercise session twice a week, or a non-intervention control group.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. The Vårdal Foundation (Sweden)
2. The Swedish Rheumatism Association in Stockholm (Sweden)
3. The Swedish Rheumatism Association in Gothenburgh (Sweden)
4. The Swedish Research Council (Sweden)
5. The Department of Research and Development at Spenshult Hospital for Rheumatic Diseases (Sweden)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15924620
Contact name Dr  Ingemar  Petersson
  Address Spenshult Hospital for Rheumatic Diseases
  City/town Oskarström
  Zip/Postcode S-313 92
  Country Sweden
  Email ingemar.petersson@spenshult.se
Sponsor The Swedish Rheumatism Association (Sweden)
  Address Alströmergatan 39
Box 12851
  City/town Stockholm
  Zip/Postcode S-112 98
  Country Sweden
  Email jan.bagge@reumatikerforbundet.se
  Sponsor website: http://www.reumatikerforbundet.org
Date applied 15/08/2005
Last edited 20/12/2007
Date ISRCTN assigned 16/08/2005
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