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ISRCTN
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ISRCTN69158864
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ClinicalTrials.gov identifier
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Public title
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The effect of Exercise on Prescription (EoP) on activity levels in heart patients after a completed period of training in outpatient setting
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Scientific title
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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
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Acronym
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EoP
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Regional Ethical Review Board, Stockholm, Sweden, 7 October 2011, ref: 2011/1226-31/2
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Study design
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Randomised controlled trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Coronary artery disease
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/12/2011
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Anticipated end date
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31/12/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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90
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Interventions
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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.
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Primary outcome measure(s)
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International Physical Activity Questionnaire, short form measured at baseline and after four months
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Secondary outcome measure(s)
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Submaximal bicycle exercise test measured at baseline and after four months
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Sources of funding
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Centre for Clinical Research Sörmland, Uppsala University (Sweden)
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Trial website
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Publications
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Contact name
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Mrs
Jenny
Lordell
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Address
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Sjukgymnastiken
Nyköpings lasarett
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City/town
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Nyköping
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Zip/Postcode
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SE-61185
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Country
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Sweden
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Sponsor
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Uppsala University (Sweden)
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Address
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Centre for Clinical Research Sörmland
Kungsgatan 41
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City/town
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Eskilstuna
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Zip/Postcode
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SE-63188
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Country
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Sweden
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Sponsor website:
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http://www.uu.se/en/
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Date applied
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29/11/2011
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Last edited
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17/04/2012
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Date ISRCTN assigned
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19/12/2011
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