Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden
RECREATION
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
February 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMay 12, 2023
May 1, 2023
4.9 years
March 15, 2018
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Muscle endurance capacity
Baseline and 12 weeks
Isometric grip strength
Baseline and 12 weeks
Self-reported physical activity using theInternational Physical Activity Questionnaire
Baseline and 12 weeks
Self-reported physical activity using the physical activity scale br Frändin and Grimby
Baseline and 12 weeks
Kinesiophobia (fear of movement)
Baseline and 12 weeks
Other Outcomes (2)
Evaluation of change the participation rate in supervised cardiac rehabilitation
12 weeks
Patients experiences of REMOTE-CR and and exercise led via video link
12 weeks
Study Arms (2)
REMOTE-CR
EXPERIMENTALRemotely 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
OTHERThe 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
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.
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Clinically unstable
- Postoperative infection
- Comorbidity affecting ability to participate in exCR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Umeå University Hospital
Umeå, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Sandberg, PhD
Umeå University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 15, 2018
First Posted
March 27, 2018
Study Start
February 3, 2019
Primary Completion
December 31, 2023
Study Completion
February 28, 2024
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share