The Amsterdam Graded Activity Study
| ISRCTN | ISRCTN46141261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46141261 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 02/11/2022
- 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 W. van Mechelen
Scientific
Scientific
Vrije University Medical Centre (VUMC)
Department of Social Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4448410 |
|---|---|
| w.vanmechelen@vumc.nl |
Study information
| Study design | Randomised, single blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The Amsterdam Graded Activity Study |
| Study acronym | AGAS |
| Study objectives | A behaviour-oriented physical exercise program (graded activity) is more effective than usual care in sick-listed workers with low back pain with regard to return to work, disability, pain and pain-related fears. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | Graded activity: The graded activity intervention consisted of two sessions of physical exercises a week until full return to regular work was achieved. The intervention was supervised by skilled physiotherapists. During the course of the intervention the load of the exercises was gradually increased towards a preset exercise goal, following a time-contingent exercise scheme. The exercise goals were connected with return-to-work goals. The intervention had a maximum duration of three months. Usual care: The workers who were allocated to the usual care group received the usual guidance by the occupational physician. There were no special requirements for other treatments except that the workers were not allowed to attend treatment sessions at the same physiotherapy practice where the workers of the graded activity group were treated. |
| Intervention type | Other |
| Primary outcome measure | 1. Days of sick leave due to low back pain 2. Disability 3. Pain |
| Secondary outcome measures | Pain-related fears |
| Overall study start date | 01/04/1999 |
| Completion date | 31/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 134 |
| Total final enrolment | 134 |
| Key inclusion criteria | 1. Sick leave because of non-specific low back pain. This could be either full or partial sick leave 2. A minimum duration of the complaints of four weeks in succession |
| Key exclusion criteria | 1. Radiation below the knee in combination with signs of nerve root compression 2. Cardiovascular contra-indications for physical activity, as checked by the Physical Activities Readiness Questionnaire 3. A conflict between worker and employer with legal involvement 4. Pregnancy |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 31/01/2002 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Public and Occupational Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Government
The Dutch Health Care Insurance Board (CVZ) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/01/2004 | Yes | No | ||
| Results article | 01/12/2005 | Yes | No | ||
| Results article | 01/07/2007 | Yes | No | ||
| Results article | 15/05/2008 | 02/11/2022 | Yes | No |
Editorial Notes
02/11/2022: Publication reference and total final enrolment added.
