The effect of Exercise on Prescription (EoP) on activity levels in heart patients after a completed period of training in outpatient setting
| ISRCTN | ISRCTN69158864 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69158864 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/11/2011
- Registration date
- 19/12/2011
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Staffan Eriksson
Scientific
Scientific
-
Nyköping
SE-61185
Sweden
| staffan.eriksson@umu.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of Exercise on Prescription (EoP) on activity levels in coronary artery disease patients after a completed a period of training in outpatient setting: a randomised controlled trial |
| Study acronym | EoP |
| Study objectives | Primary hypothesis: Information given as Exercise on Prescription (EoP) after a completed period of training in a coronary rehabilitation outpatients setting, including motivational interviewing, gives a larger proportion of individuals that reach an activity level equivalent to 1200 Metabolic Equivalent Task (MET) per week or more compared to orally given advice to be physically active. Secondary hypotheses: 1. Information given as EoP after a completed period of training in a coronary rehabilitation outpatient setting, including motivational interviewing, gives a higher energy expenditure per week compared to orally given advice to be physically active. 2. Information given as EoP after a completed period of training in a coronary rehabilitation outpatient setting, including motivational interviewing, gives a higher energy expenditure per week by way of moderate intensity exercise (4-8 MET) compared to orally given advice to be physically active. 3. Information given as EoP after a completed period of training in a coronary rehabilitation outpatient setting, including motivational interviewing, gives a higher energy expenditure per week by way of high intensity exercise (≥8 MET) compared to orally given advice to be physically active. 4. Information given as EoP after a completed period of training in a coronary rehabilitation outpatient setting, including motivational interviewing, gives a higher exercise capacity as measured by a submaximal bicycle exercise test compared to orally given advice to be physically active. On 12/01/2015 the overall trial end date was changed from 31/12/2014 to 31/12/2017. |
| Ethics approval(s) | Regional Ethical Review Board, Stockholm, Sweden, 07/10/2011, ref: 2011/1226-31/2 |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Prior to study start all of the participants participate in the standard heart rehabilitation group for outpatients diagnosed with coronary artery disease at the Hospital of Nyköping. This standard heart rehabilitation is comprised of strength and fitness training up to three times per week and three months, in line with the Swedish guidelines for heart rehabilitation. In addition to the guidelines group relaxation is also performed two of three sessions each week. On the final session of the standard heart rehabilitation group, all participants will be advised to continue to be physically active, with specific emphasis placed on the importance of fitness training. After termination of the standard heart rehabilitation group participants will be randomly allocated to either an EoP-group or a control group. The control group will receive only the information mentioned above that all participants receive. After completing the standard heart rehabilitation period outlined above, the EoP-group will meet a physiotherapist for a motivational interview (MI) and an exercise prescription. Two months after this meeting a follow up by telephone will be done. The EoP physiotherapist does not work in the heart rehabilitation team and is not involved in the standard heart rehabilitation group. The prescription can be for any form of exercise, but must last for thirty minutes or more of physical activity daily, and also include fitness training three times a week and strength training twice a week. The strength and fitness training can be combined in the same session. The training intensity for fitness training should be 12-15/20 on the Borg's RPE-scale for 20-40 minutes, depending on the intensity, with higher intensity requiring shorter training duration. The training intensity of strength training should be between 11-13/20 on the Borg's RPE-scale in the trained muscle. Strength training should be comprised of 1-3 sets of 12-15 repetitions of 8-10 different exercises. |
| Intervention type | Behavioural |
| Primary outcome measure | International Physical Activity Questionnaire, short form measured at baseline and after 4 months |
| Secondary outcome measures | Submaximal bicycle exercise test measured at baseline and after 4 months |
| Overall study start date | 01/12/2010 |
| Completion date | 22/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Current inclusion criteria as of 17/04/2012: 1. Age 75 years or less 2. Coronary artery disease 3. Completion of a minimum of eight weeks, with a mean of at least one day per week, of group training for outpatients Previous inclusion criteria: 1. Age 70 years or less 2. Coronary artery disease 3. Completion of a minimum of eight weeks, with a mean of at least one day per week, of group training for outpatients |
| Key exclusion criteria | 1. Chronic obstructive lung-disease, according to medical records 2. Heart failure, according to medical records 3. Submaximal bicycle exercise test or survey administered by different physiotherapists at baseline an after the intervention period |
| Date of first enrolment | 21/12/2011 |
| Date of final enrolment | 22/12/2021 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Sjukgymnastiken
Nyköping
SE-61185
Sweden
SE-61185
Sweden
Sponsor information
Uppsala University (Sweden)
University/education
University/education
Centre for Clinical Research Sörmland
Kungsgatan 41
Eskilstuna
SE-63188
Sweden
| Website | http://www.uu.se/en/ |
|---|---|
"ROR" |
https://ror.org/048a87296 |
Funders
Funder type
University/education
Centre for Clinical Research Sörmland, Uppsala University (Sweden)
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer reviewed journal with the intent to publish around one year after the overall trial end date. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because the researchers have promised confidentiality in the information letter to the participants. Specifically, they have stated that only the researchers conducting the study will be able to view the data at an individual level and that only group-level data will be displayed to individuals outside of the research group. This statement has also been approved by the Ethical Review Board in Stockholm. |
Editorial Notes
27/05/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 22/12/2021.
2. The overall end date was changed from 31/12/2022 to 22/12/2021.
12/05/2025: Contact details updated.
12/04/2023: The scientific contact's details have been changed.27/11/2020: IPD sharing statement added.
23/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 31/12/2021.
2. The overall end date was changed from 31/12/2021 to 31/12/2022.
3. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
22/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 31/12/2020.
2. The overall end date was changed from 31/12/2020 to 31/12/2021.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
07/02/2018: The following changes were made:
1. Overall trial start date was changed from 01/12/2011 to 01/12/2010.
2. Recruitment start date was changed from 01/12/2011 to 21/12/2011.
3. Recruitment end date was changed from 31/12/2017 to 31/12/2019.
4. Overall trial end date was changed from 31/12/2017 to 31/12/2020.
5. Publication and dissemination plan, intention to publish date and participant level data were added.
