Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial
ISRCTN | ISRCTN20244858 |
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DOI | https://doi.org/10.1186/ISRCTN20244858 |
Secondary identifying numbers | N/A |
- Submission date
- 15/08/2005
- Registration date
- 16/08/2005
- Last edited
- 20/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ingemar Petersson
Scientific
Scientific
Spenshult Hospital for Rheumatic Diseases
Oskarström
S-313 92
Sweden
ingemar.petersson@spenshult.se |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 09/10/1998 |
Completion date | 08/10/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Spenshult Hospital for Rheumatic Diseases
Oskarström
S-313 92
Sweden
S-313 92
Sweden
Sponsor information
The Swedish Rheumatism Association (Sweden)
Charity
Charity
Alströmergatan 39
Box 12851
Stockholm
S-112 98
Sweden
jan.bagge@reumatikerforbundet.se | |
Website | http://www.reumatikerforbundet.org |
https://ror.org/00zps9v98 |
Funders
Funder type
Research organisation
The Vårdal Foundation (Sweden)
No information available
The Swedish Rheumatism Association in Stockholm (Sweden)
No information available
The Swedish Rheumatism Association in Gothenburgh (Sweden)
No information available
The Swedish Research Council (Sweden)
No information available
The Department of Research and Development at Spenshult Hospital for Rheumatic Diseases (Sweden)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 30/05/2005 | Yes | No |