Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

Heart Defects, Congenital Clinical Trial

— RECREATION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479957
• Other study ID #: RemoteCR SWE
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2019
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2023
• Source: Umeå University
• Contact: Camilla Sandberg, PhD
• Phone: +46907858441
• Email: camilla.sandberg[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

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:
• 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)

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Muscle endurance capacity	Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift	Baseline and 12 weeks
Secondary	Isometric grip strength	Isometric grip strength will be evaluated using a hydraulic hand dynamometer	Baseline and 12 weeks
Secondary	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
Secondary	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
Secondary	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