Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
EoP
Study hypothesis
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
Regional Ethical Review Board, Stockholm, Sweden, 07/10/2011, ref: 2011/1226-31/2
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
International Physical Activity Questionnaire, short form measured at baseline and after four months
Secondary outcome measures
Submaximal bicycle exercise test measured at baseline and after four months
Overall trial start date
01/12/2010
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant 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
Recruitment start date
21/12/2011
Recruitment end date
31/12/2020
Locations
Countries of recruitment
Sweden
Trial participating centre
Sjukgymnastiken
Nyköping
SE-61185
Sweden
Sponsor information
Organisation
Uppsala University (Sweden)
Sponsor details
Centre for Clinical Research Sörmland
Kungsgatan 41
Eskilstuna
SE-63188
Sweden
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Centre for Clinical Research Sörmland, Uppsala University (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/12/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list