Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
NCT ID: NCT02895451
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2016-12-15
2021-06-30
Brief Summary
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Detailed Description
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The extended intervention is based on components from behavioral medicine including: specific goal-setting, self-monitoring and feed-back.
Changes in the endpoint variables will be measured from baseline to first (16 weeks at end of intervention) and second (12 months after index event) follow-up visits.
Sample size calculations are based on previous clinical data from a similar exercise-based CR setting (n=50) on differences in aerobic exercise capacity measured by submaximal exercise test (watts) before vs after finished exercise-based CR. With a power of 80% and a two-sided significance level of p\<0.05 and least mean difference at 10 watts (SD 20 watts) and a calculated loss of follow-up of 20%, the estimated sample size is 160 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Extended behavioral intervention
Specific goal-setting, self-monitoring and feed-back
Extended behavioral intervention
The exercise goal is set in liaison between the patient and the physiotherapist, based on activities and target behaviors that the patient thinks is relevant and important. The patients are asked to self-monitor the defined exercise goal by completing an exercise diary. The exercise diary includes specification of the performed exercise dose (frequency, intensity and duration). The exercise diary is followed up by a physiotherapist every third week by a phone call or a personal meeting. Visual feed-back on the performed dose of exercise is given once by accelerometry. At end of intervention (16 weeks) the patient is offered a follow-up meeting with the physiotherapist to discuss a long-term exercise goal.
Usual care
Hospital-based or home-based aerobic exercise 3 times a week with a duration of 30-60 minutes and an intensity of 40-80 % of Vo2max and resistance exercise 2 times a week of 1-3 sets of 10-15 repetitions. The exercise period is 16 weeks.
No interventions assigned to this group
Interventions
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Extended behavioral intervention
The exercise goal is set in liaison between the patient and the physiotherapist, based on activities and target behaviors that the patient thinks is relevant and important. The patients are asked to self-monitor the defined exercise goal by completing an exercise diary. The exercise diary includes specification of the performed exercise dose (frequency, intensity and duration). The exercise diary is followed up by a physiotherapist every third week by a phone call or a personal meeting. Visual feed-back on the performed dose of exercise is given once by accelerometry. At end of intervention (16 weeks) the patient is offered a follow-up meeting with the physiotherapist to discuss a long-term exercise goal.
Eligibility Criteria
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Inclusion Criteria
* Age \<75 years
Exclusion Criteria
* Inability to understand the Swedish language
18 Years
75 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Maria Bäck
PhD, RPT
Principal Investigators
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Maria Bäck, PhD
Role: STUDY_CHAIR
Linkoeping University, Department of Medical and Health Sciences, Division of Physiotherapy
Locations
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Linkoeping University
Linköping, , Sweden
Countries
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References
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Borg S, Oberg B, Nilsson L, Alfredsson J, Soderlund A, Back M. Effectiveness of a behavioral medicine intervention in physical therapy on secondary psychological outcomes and health-related quality of life in exercise-based cardiac rehabilitation: a randomized, controlled trial. BMC Sports Sci Med Rehabil. 2023 Mar 24;15(1):42. doi: 10.1186/s13102-023-00647-x.
Freene N, Borg S, McManus M, Mair T, Tan R, Davey R, Oberg B, Back M. Comparison of device-based physical activity and sedentary behaviour following percutaneous coronary intervention in a cohort from Sweden and Australia: a harmonised, exploratory study. BMC Sports Sci Med Rehabil. 2020 May 9;12:17. doi: 10.1186/s13102-020-00164-1. eCollection 2020.
Borg S, Oberg B, Nilsson L, Soderlund A, Back M. The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) - the study protocol of a randomised, controlled trial. BMC Cardiovasc Disord. 2017 May 25;17(1):134. doi: 10.1186/s12872-017-0557-7.
Other Identifiers
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Dnr: 2015/209-31
Identifier Type: -
Identifier Source: org_study_id