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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02895451
Other study ID # Dnr: 2015/209-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2016
Est. completion date June 2021

Study information

Verified date October 2021
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date June 2021
Est. primary completion date April 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Primary care event due to coronary artery disease and/or percutaneous coronary intervention (PCI) at the coronary care unit, Linköping University hospital - Age <75 years Exclusion Criteria: - Serious physical or psychological disease interfering with participation in exercise-based CR - Inability to understand the Swedish language

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Sweden Linkoeping University Linkoeping

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline aerobic exercise capacity (watts) at 4 months The test is performed on a bicycle ergometer according to the WHO-protocol with an increased workload of 25W every 4.5 minutes.The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 at Borg´s CR-10 scale. 4 months
Secondary Adherence to dose of exercise accelerometer 4 months
Secondary Adherence to dose in exercise exercise diary 4 months
Secondary Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months Muscle endurance test 4 months
Secondary Change from baseline unilateral isotonic heel lift (repetitions) at 4 months Muscle endurance test 4 months
Secondary Change from baseline anxiety score at 4 months Hospital Anxiety and Depression Scale (HADS) 4 months
Secondary Change from baseline depression score at 4 months Hospital Anxiety and Depression Scale (HADS) 4 months
Secondary Change from baseline self-efficacy score at 4 months Self Efficacy Exercise Scale (SEE-SV) 4 months
Secondary Change from baseline health-related quality of life score at 4 months Short-Form-36 (SF-36) 4 months
Secondary Change from baseline health-related quality of life score at 4 months EQ5D 4 months
Secondary Change from baseline level of physical activity at 4 months Accelerometer 4 months
Secondary Change from baseline level of physical activity at 4 months Bouchard questionnaire 4 months
Secondary Change from baseline aerobic exercise capacity (watts) at 12 months Submaximal exercise test on bicycle ergometer 12 months
Secondary Adherence to dose of exercise Accelerometer 12 months
Secondary Adherence to dose of exercise Exercise diary 12 months
Secondary Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months Muscle endurance test 12 months
Secondary Change from baseline unilateral isotonic heel lift (repetitions) at 12 months Muscle endurance test 12 months
Secondary Change from baseline anxiety score at 12 months Hospital Anxiety and Depression Scale (HADS) 12 months
Secondary Change from baseline depression score at 12 months Hospital Anxiety and Depression Scale (HADS) 12 months
Secondary Change from baseline self-efficacy score at 12 months Self Efficacy Exercise Scale (SEE-SV) 12 months
Secondary Change from baseline health-related quality of life score at 12 months Short-Form-36 (SF-36) 12 months
Secondary Change from baseline health-related quality of life score at 12 months EQ5D 2 months
Secondary Change from baseline level of physical activity at 12 months accelerometer 12 months
Secondary Change from baseline level of physical activity at 12 months Bouchard questionnaire 12 months
Secondary Patient Enablement (score) Patient Enablement Instrument (PEI) 12 months
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