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Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden (RECREATION)

Primary Purpose

Heart Defects, Congenital

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
REMOTE-CR
Control
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Umeå University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

REMOTE-CR

Usual care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Muscle endurance capacity
Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift
Isometric grip strength
Isometric grip strength will be evaluated using a hydraulic hand dynamometer
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
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.
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.

Full Information

First Posted
March 15, 2018
Last Updated
May 11, 2023
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT03479957
Brief Title
Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden
Acronym
RECREATION
Official Title
Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REMOTE-CR
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Other
Arm Description
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
Behavioral
Intervention Name(s)
REMOTE-CR
Intervention Description
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
Other
Intervention Name(s)
Control
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in submaximal aerobic exercise capacity
Description
The aerobic exercise capacity (W) will be evaluated using a standardised submaximal exercise test on cycle ergometer
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Muscle endurance capacity
Description
Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift
Time Frame
Baseline and 12 weeks
Title
Isometric grip strength
Description
Isometric grip strength will be evaluated using a hydraulic hand dynamometer
Time Frame
Baseline and 12 weeks
Title
Self-reported physical activity using theInternational Physical Activity Questionnaire
Description
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
Time Frame
Baseline and 12 weeks
Title
Self-reported physical activity using the physical activity scale br Frändin and Grimby
Description
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.
Time Frame
Baseline and 12 weeks
Title
Kinesiophobia (fear of movement)
Description
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.
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Evaluation of change the participation rate in supervised cardiac rehabilitation
Description
Evaluation of change the participation rate can be enhanced using the REMOTE -CR system
Time Frame
12 weeks
Title
Patients experiences of REMOTE-CR and and exercise led via video link
Description
The study participants experience of the REMOTE-CR system and exercise sessions via video link will be evaluated using a questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Sandberg, PhD
Phone
+46907858441
Email
camilla.sandberg@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Cronesten, RPT
Phone
+46907858441
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Sandberg, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umeå University Hospital
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Sandberg, PhD
Phone
+46907858441
First Name & Middle Initial & Last Name & Degree
Helena Cronesten, RPT
Phone
+46907858441

12. IPD Sharing Statement

Plan to Share IPD
No

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Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

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