Condition category
Circulatory System
Date applied
29/11/2011
Date assigned
19/12/2011
Last edited
12/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jenny Lordell

ORCID ID

Contact details

Sjukgymnastiken
Nyköpings lasarett
Nyköping
SE-61185
Sweden

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 measures

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

01/12/2011

Overall trial end date

31/12/2017

Reason abandoned

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

01/12/2011

Recruitment end date

31/12/2017

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

http://www.uu.se/en/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes