Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden (RECREATION)

Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Defects, Congenital
• Intervention / Treatment: Behavioral: REMOTE-CR; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla Sandberg, PhD; Phone Number: +46907858441; Email: camilla.sandberg@umu.se
• Study Contact Backup: Name: Helena Cronesten, RPT; Phone Number: +46907858441

Study Locations

• Sweden
  • Umeå, Sweden
    • Recruiting
    • Umea University Hospital
    • Contact: Helena Cronesten, RPT; Phone Number: +46907858441
    • Contact: Camilla Sandberg, PhD; Phone Number: +46907858441

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: REMOTE-CR; 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. Remotely monitored exercise training sessions will be offered monday-friday 13.00-16.00.
Other: Usual care; 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).	Other: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle endurance capacity	Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift	Baseline and 12 weeks
Isometric grip strength	Isometric grip strength will be evaluated using a hydraulic hand dynamometer	Baseline and 12 weeks
Self-reported physical activity using theInternational Physical Activity Questionnaire	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	Baseline and 12 weeks
Self-reported physical activity using the physical activity scale br Frändin and Grimby	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.	Baseline and 12 weeks
Kinesiophobia (fear of movement)	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.	Baseline and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of change the participation rate in supervised cardiac rehabilitation	Evaluation of change the participation rate can be enhanced using the REMOTE -CR system	12 weeks
Patients experiences of REMOTE-CR and and exercise led via video link	The study participants experience of the REMOTE-CR system and exercise sessions via video link will be evaluated using a questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Camilla Sandberg, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: RemoteCR SWE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No