Background
Rehabilitation
Study objectives
Design
Study population and eligibility criteria
Study procedure
Control group – usual care
Experimental intervention group
Physical exercise training component
Supervised exercise training programme
Education in groups and individual consultation
Outcomes and data collection
Quantity | Time of measure | Type of quantity |
---|---|---|
Demographic | ||
Sex | Baseline | Binary (M/F) |
Age, height, weight, body mass index (BMI) | Baseline | Continuous |
Marital, occupational, educational status | Baseline | Categorical |
Clinical | ||
Charlson Comorbidity Index [34] | Baseline, 6, 12 | Categorical |
Hypertension | Baseline 6, 12 | Binary (Y/N) |
Smoking+ Fagerströms test, (Alcohol Timeline Followback) | Baseline, 6, 12 | Categorical |
Medication (routine drugs; antiplatelet; statins and other medication) | Baseline, 6, 12 | Categorical |
Nutritional screening ‘HjerteKost’: fat-fish-fruit-green score [35] | Baseline, 6, 12 | Categorical |
Paraclinical | ||
Blood work (biomarkers, cholesterol, HBa1C, Hg, thyroid) | Baseline, 6, 12 | Continuous |
Physical function | ||
Baseline, 6, 12 | Continuous | |
Six-minute walking test (before and after supervised exercise training) [38] | Baseline, 3 | Continuous |
Sit to stand test (before and after supervised exercise training) [39] | Baseline, 3 | Continuous |
Level of physical activity (0–7 times a week) | Baseline, 6, 12 | Categorical |
Questionnaires | ||
HADS, Hospital Anxiety and Depression Scale [40] | Baseline, 6, 12 | Categorical |
VascuQol, Vascular Quality of Life questionnaire [41] | Baseline, 6, 12 | Categorical |
PAM13, 13-item Patient Activation Measure [42] | Baseline, 6, 12 | Categorical |
Pedometer, text message (intervention group) | 3 months, 6 | Binary (Y/N) |
Participation in dietician and nurse session (intervention group) | 3 months | Binary (Y/N) |
Supervised exercise training: physiotherapist. Content and education | |
Education session: nurse and dietician. Content and education | |
Patients’ experiences of participating in the intervention group. | |
Knowledge and uncertainty about IC | |
Experiences of factors and barrier that supported or hindered adherence to the intervention. | |
Factors that influence coping strategy, persistent lifestyle changes | |
Importance of environment and togetherness with similar patients | |
Empathy, support and motivation | |
Risk factor management | |
Coping behaviours | |
Change interventions | |
Attitudes, beliefs, how to handle the pain | |
Feeling better mentally | |
Accessibility and compliance | |
Self-monitoring goal setting | |
Exercise logbook and pedometers. Motivational text message. | |
Specific walking advice to promote self-managed walking | |
Quality of life | |
Solution behaviour change techniques | |
Patient satisfaction of participate in the IC rehabilitation programme and point out if any suggestions for changes. |