RECREATION: Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

Sponsor
Umeå University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03479957
Collaborator
(none)
90
1
2
46.9
1.9

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: REMOTE-CR
  • Other: Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l
Actual Study Start Date :
Feb 3, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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: 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).

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)

Outcome Measures

Primary Outcome Measures

  1. Change in submaximal aerobic exercise capacity [Baseline and 12 weeks]

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

Secondary Outcome Measures

  1. Muscle endurance capacity [Baseline and 12 weeks]

    Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift

  2. Isometric grip strength [Baseline and 12 weeks]

    Isometric grip strength will be evaluated using a hydraulic hand dynamometer

  3. Self-reported physical activity using theInternational Physical Activity Questionnaire [Baseline and 12 weeks]

    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

  4. Self-reported physical activity using the physical activity scale br Frändin and Grimby [Baseline and 12 weeks]

    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.

  5. Kinesiophobia (fear of movement) [Baseline and 12 weeks]

    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.

Other Outcome Measures

  1. Evaluation of change the participation rate in supervised cardiac rehabilitation [12 weeks]

    Evaluation of change the participation rate can be enhanced using the REMOTE -CR system

  2. Patients experiences of REMOTE-CR and and exercise led via video link [12 weeks]

    The study participants experience of the REMOTE-CR system and exercise sessions via video link will be evaluated using a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Umeå University Hospital Umeå Sweden

Sponsors and Collaborators

  • Umeå University

Investigators

  • Principal Investigator: Camilla Sandberg, PhD, Umeå University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Camilla Sandberg, Principal Investigator, Umeå University
ClinicalTrials.gov Identifier:
NCT03479957
Other Study ID Numbers:
  • RemoteCR SWE
First Posted:
Mar 27, 2018
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2021