Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

NCT ID: NCT03479957

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-03

Study Completion Date

2024-02-28

Brief Summary

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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

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Conditions

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Heart Defects, Congenital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

REMOTE-CR

Intervention Type BEHAVIORAL

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.

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).

Group Type OTHER

Control

Intervention Type 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)

Interventions

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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.

Intervention Type BEHAVIORAL

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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Camilla Sandberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camilla Sandberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Umeå University Hospital

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Camilla Sandberg, PhD

Role: CONTACT

+46907858441

Helena Cronesten, RPT

Role: CONTACT

+46907858441

Facility Contacts

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Camilla Sandberg, PhD

Role: primary

+46907858441

Helena Cronesten, RPT

Role: backup

+46907858441

Other Identifiers

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RemoteCR SWE

Identifier Type: -

Identifier Source: org_study_id

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