Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

Not Applicable

Recruiting

• Conditions: Heart Defects, Congenital
• Interventions: Behavioral: REMOTE-CR; Other: Control

• Registration Number: NCT03479957
• Lead Sponsor: Umeå University

Brief Summary

Supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in rural and remote areas of Sweden. The main reasons for low participation rate in centre-based exCR are different accessibility barriers i.e. long distances, transportation problems or employment commitments. In this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system compared to home-based exCR based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise capacity to a greater extent than home-based exCR without monitoring and coaching (usual care).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-27
• Study Start: 2019-02-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Scheduled appointment with physiotherapist for follow-up after cardiac event: ----Myocardial Infarction (MI)
• Per cutaneous coronary intervention (PCI) due to MI or angina pectoris
• Open heart surgery due to coronary artery disease or valvar disease
• Living in the catchment area of Heart centre, University Hospital of Umeå.

Exclusion Criteria

• Clinically unstable
• Postoperative infection
• Comorbidity affecting ability to participate in exCR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REMOTE-CR	REMOTE-CR	Remotely monitored and coached exercise training in real time using the REMOTE-CR system. The patients randomized to remotely monitored exercise can either work out with self-selected activities e.g. Nordic-walking, cycling, skiing or participate in supervised exercise session via video link.
Usual care	Control	The patients randomized to be controls will receive individualized information and instructions regarding current exercise recommendations but will not be monitored or coached during their exercise sessions (usual care).

Primary Outcome Measures

Name	Time	Method
Change in submaximal aerobic exercise capacity	Baseline and 12 weeks	The aerobic exercise capacity (W) will be evaluated using a standardised submaximal exercise test on cycle ergometer

Secondary Outcome Measures

Name	Time	Method
Muscle endurance capacity	Baseline and 12 weeks	Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift
Isometric grip strength	Baseline and 12 weeks	Isometric grip strength will be evaluated using a hydraulic hand dynamometer
Self-reported physical activity using the physical activity scale br Frändin and Grimby	Baseline and 12 weeks	The Activity scale by Frändin and Grimby describes 6 levels of physical activity. The scale includes 6 items that ranges from 1 indicating mostly physically inactive to 6 indicating a very high physical activity level.
Self-reported physical activity using theInternational Physical Activity Questionnaire	Baseline and 12 weeks	International Physical Activity Questionnaire: Results will be presented as a continuous variable, total metabolic equivalent (MET) minutes per week, where a higher score indicates a higher physical activity level. Result will also be presented as a categorical variable: High Physical activity level: achieving a total physical activity of at least 3000 MET-minutes/week.; Moderate physical activity: achieving a minimum of at least 600 MET-minutes per week.; Low physical activity level: not achieving the minimum of 600 MET minutes per week
Kinesiophobia (fear of movement)	Baseline and 12 weeks	The Swedish version of the Tampa scale for Kinesiophobia Heart (TSK-SV Heart) The scale comprises 17 items assessing subjective rating of kinesiophobia. The total score varies between 17-68 and a score \>37 defines a high level of kinesofobia.

Trial Locations

Locations (1)

Umeå University Hospital; 🇸🇪 Umeå, Sweden