Remote Exercise SWEDEHEART Study

Myocardial Infarction Clinical Trial

Official title:

Remote Exercise SWEDEHEART Study - a Multicentre Registry-based Cluster Randomized Crossover Clinical Trial (RRCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04260958
• Other study ID #: U-2018-312
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: June 1, 2028

Study information

• Verified date: July 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Maria Back, Ass Prof
• Phone: +46700895612
• Email: maria.m.back[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Diagnosis of type 1 myocardial infarction (AMI)

• Age 18-79 years at discharge from hospital

Exclusion Criteria:

• Patients with incomplete coronary revascularization defined as at least one remaining hemodynamically significant stenosis

• Severe valve or structural heart disease

• Severe heart failure (NYHA III - IV)

• Serious arrythmias

• Inability to understand Swedish

• No internet access at home (only applicable for patients in the intervention group who wants to perform remote exCR)

• Pathological exercise test indicating high risk for adverse events during exCR

• More than 6 months between discharge form hospital and screening

• Any other condition that may interfere with the possibility for the patient to comply with the study protocol

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Exercise-based cardiac rehabilitation
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.

Locations

Country	Name	City	State
Sweden	Södra Älvsborg Hospital	Borås
Sweden	Mälarsjukhuset	Eskilstuna
Sweden	Falun hospital	Falun
Sweden	Gällivare Hospital	Gällivare
Sweden	Gävle Hospital	Gävle
Sweden	Angered Hospital	Gothenburg
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Sahlgrenska University Hospital Östra	Gothenburg
Sweden	Hässleholm Hospital	Hässleholm
Sweden	Jönköping Ryhov hospital	Jönköping
Sweden	Kalix hospital	Kalix
Sweden	Kalmar Hospital	Kalmar
Sweden	Kungälv Hospital	Kungälv
Sweden	Lindesberg Hospital	Lindesberg
Sweden	Linköping University Hospital	Linköping
Sweden	Ljungby Hospital	Ljungby
Sweden	Sunderbyn hospital	Luleå
Sweden	Skåne University hospital	Lund
Sweden	Skåne University Hospital Malmö	Malmö
Sweden	Östersund hospital	Östersund
Sweden	Södertälje Hospital	Södertälje
Sweden	Capio St Göran Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Sundsvall hospital	Sundsvall
Sweden	Uppsala University Hopsital	Uppsala
Sweden	Värnamo hospital	Värnamo

Sponsors (4)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Göteborg University, Linkoeping University, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-4 months
Secondary	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.	3-4 months
Secondary	Muscular endurance tests	Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)	3-4 months
Secondary	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.	3-4 months
Secondary	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.	3-4 months
Secondary	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	3-4 months
Secondary	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.	3-4 months
Secondary	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)	3-4 months
Secondary	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).	3-4 months
Secondary	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	3-4 months
Secondary	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.	3-4 months
Secondary	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.	End of study
Secondary	Socio-economic evaluation	Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data	6 years
Secondary	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.	1 and 3 years after the last patient visit