Condition category
Musculoskeletal Diseases
Date applied
15/08/2005
Date assigned
16/08/2005
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.reumatikerforbundet.org

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

  1. 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.

Additional files

Editorial Notes