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Clinical Trials/NCT03479957
NCT03479957RecruitingNot Applicable

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

Umeå University1 site in 1 country90 target enrollmentStarted: February 3, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
Change in submaximal aerobic exercise capacity

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

REMOTE-CR

Experimental

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.

Intervention: REMOTE-CR (Behavioral)

Usual care

Other

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).

Intervention: Control (Other)

Outcomes

Primary Outcomes

Change in submaximal aerobic exercise capacity

Time Frame: Baseline and 12 weeks

The aerobic exercise capacity (W) will be evaluated using a standardised submaximal exercise test on cycle ergometer

Secondary Outcomes

  • Muscle endurance capacity(Baseline and 12 weeks)
  • Isometric grip strength(Baseline and 12 weeks)
  • Self-reported physical activity using the physical activity scale br Frändin and Grimby(Baseline and 12 weeks)
  • Self-reported physical activity using theInternational Physical Activity Questionnaire(Baseline and 12 weeks)
  • Kinesiophobia (fear of movement)(Baseline and 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Camilla Sandberg

Principal Investigator

Umeå University

Study Sites (1)

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