Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial

ISRCTN	ISRCTN20244858
DOI	https://doi.org/10.1186/ISRCTN20244858
Protocol serial number	N/A
Sponsor	The Swedish Rheumatism Association (Sweden)
Funders	The Vårdal Foundation (Sweden), The Swedish Rheumatism Association in Stockholm (Sweden), The Swedish Rheumatism Association in Gothenburgh (Sweden), The Swedish Research Council (Sweden), The Department of Research and Development at Spenshult Hospital for Rheumatic Diseases (Sweden)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ingemar Petersson
Scientific

Spenshult Hospital for Rheumatic Diseases
Oskarström
S-313 92
Sweden

Email	ingemar.petersson@spenshult.se

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	Knee osteoarthritis
Intervention	A six-week high-intensity supervised exercise session twice a week, or a non-intervention control group.
Intervention type	Other
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.
Key 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
Completion date	08/10/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	61
Key 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)
Key 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
Date of first enrolment	09/10/1998
Date of final enrolment	08/10/2001

Spenshult Hospital for Rheumatic Diseases

Oskarström
S-313 92
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	30/05/2005		Yes	No