Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-24 @ 5:38 AM
Study NCT ID:
NCT02895451
Status:
COMPLETED
Last Update Posted:
2021-10-18
First Post:
2016-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Sponsor:
Linkoeping University
Organization:
Study Overview
Official Title:
Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECRA
Brief Summary:
The purpose of this study is to investigate the effects of an extended behavioral intervention in exercise-based CR for improvement of physical capacity, adherence, psychological and physiological parameters, compared with usual care.
Detailed Description:
Consecutive patients will be included at the coronary care unit (CCU), Linköping University Hospital, Sweden. Physiotherapists ask patients for informed consent at the CCU and book an appointment at the exercise-based CR 2-3 weeks after discharge for baseline tests. After baseline testing patients will be randomized to either extended intervention or routine care. Randomization will be stratified by submaximal exercise capacity. Patients randomized to the extended intervention group receive an additional appointment to a physiotherapist within a week. Thereafter patients in both groups start the exercise-based CR program, including aerobic exercise and resistance exercise, 3 times/week for 16 weeks, according to international guidelines for exercise-based CR.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: