The overall aim of the study is to evaluate if remote video exercise-based cardiac rehabilitation (exCR), offered as an alternative to centre-based exCR, can increase participation in exCR sessions post myocardial infarction (MI).
Due to the covid-19 pandemic, this study will be performed in two steps: 1). National feasibility and safety study. 2). National multicenter registry-based cluster randomized crossover clinical trial (RRCT). 1. In the feasibility study, patients will be offered remote exCR at all participating sites until the peak of the pandemic has been achieved and care goes back to normal. The feasibility study will include patients until Aug 2022. 2. CR centers (not patients) will be cluster randomized to either the intervention or control. Patients at intervention centers will be offered remote exCR, usual care centre-based exCR, or a combination of both modes, as self-preferred choice. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be 15 months. Long-term follow-up will be performed 1 year and 3 years after the index cardiac event.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
The exercise program (remote/centre-based) will be standardized. An exCR-program is defined as at least 24 supervised sessions, with a total session length of 60 minutes, for at least 3 months, with possibility to complete missed sessions the 4th month. Each exercise session includes at least 20 min of aerobic exercise, intensity 13-17 on Borg´s rating of perceived exertion (RPE)-scale ≈ 60% - 85% of VO2max or 70 - 95% of maximal heart rate. In addition, each exercise session includes 1-3 sets of 8-10 upper and/or lower limb exercises in 10-15 repetitions, 40-80% of 1 repetition maximum. Attending ≥75% of the 24 sessions over a 4-month period will be considered as successful.
Södra Älvsborg Hospital
Borås, Sweden
Mean number of exCR sessions
The primary outcome is the mean number of EBCR sessions (center based or remote) during 0-4 months (from start of the EBCR program) for patients at a center during each randomization period. Eligible patients that have not started the EBCR program within 6 months of screening will be counted as 0 sessions. Attending ≥75% of the 24 recommended sessions over a 4-month period will be considered as completion, and proportion completers will be presented in a supportive responder analysis.
Time frame: 3-4 months
Submaximal exercise capacity
Bicycle ergometer test 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.
Time frame: 3-4 months
Muscular endurance tests
Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)
Time frame: 3-4 months
Self-reported physical activity and exercise
Two questions on physical activity and exercise during the latest week according to Haskell´s questionnaire (Min:0, Max:7). Ordinal scale, number of days.
Time frame: 3-4 months
Self-reported physical activity and exercise Haskell
Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise.
Time frame: 3-4 months
Self-reported physical capacity
Visual analog scale, (100=best possible physical capacity, 0=worst possible physical capacity), a dichotomous question: Do you experience any limitation in everyday life due to your current physical capacity? (yes vs no). If yes: multiple choice on reasons
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mälarsjukhuset
Eskilstuna, Sweden
RECRUITINGFalun hospital
Falun, Sweden
RECRUITINGGällivare Hospital
Gällivare, Sweden
RECRUITINGGävle Hospital
Gävle, Sweden
RECRUITINGAngered Hospital
Gothenburg, Sweden
RECRUITINGSahlgrenska University Hospital Östra
Gothenburg, Sweden
RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGHässleholm Hospital
Hässleholm, Sweden
RECRUITINGJönköping Ryhov hospital
Jönköping, Sweden
RECRUITING...and 16 more locations
Time frame: 3-4 months
Health-related quality of life EQ5D
Euro Quality of Life (EQ-5D 3L). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A high score indicates better Health.
Time frame: 3-4 months
Health-related quality of life VAS
Euro Quality of Life VAS. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state'(100) and 'Worst imaginable health state' (0)
Time frame: 3-4 months
Kinesiophobia (fear of movement)
Tampa Scale for Kinesiophobia Heart (17 items, ordinal scale 1-4) 1, strongly disagree, 4, strongly agree. A higher score is means higher values of kinesiophobia (worse).
Time frame: 3-4 months
Self-efficacy for Exercise Scale
Self-efficacy for Exercise Scale. 9 items, ordinal scale. 0=not Confident, 10=very Confident. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise
Time frame: 3-4 months
Self-reported perceptions on exercise
Patient´s perceptions of remote exCR or centre-based exCR. 1, strongly disagree, 4, strongly agree. This questionnarie is designed by the authors. High score, better outcome.
Time frame: 3-4 months
Cost-effectiveness
A cost-effectiveness analysis will be performed in order to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control. Healthcare costs associated with investigated treatments will be assessed by extracting resource use from the relevant registries, and QALYs will be determined by combining survival status and the quality-of-life measurements provided by the EQ-5D-3L instrument.
Time frame: End of study
Socio-economic evaluation
Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data
Time frame: 6 years
Number of Cardiovascular events
All-cause mortality, cardiovascular mortality, recurrent hospitalization for ACS, heart failure hospitalization, stroke and repeat coronary revascularization, reported in SWEDEHEART, the National Patient Registry and the Cause of Death Register will be performed.
Time frame: 1 and 3 years after the last patient visit