Heart Defects, CongenitalRECREATIONNCT03479957
Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden
A study testing REMOTE-CR in people with Heart Defects, Congenital, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- REMOTE-CR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 3 Feb 2019to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinically unstable
- Postoperative infection
- Comorbidity affecting ability to participate in exCR
Trial locations and contacts
1 site in 1 country.
Helena Cronesten, RPT contact
Sweden1 site, 1 recruiting
- Recruiting
Umeå University Hospital
Umeå
Camilla Sandberg, PhD, +46907858441
Helena Cronesten, RPT, +46907858441
About this study
Official title: Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l
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).
- Conditions
- Heart Defects, Congenital
- Being tested
- REMOTE-CR, Control
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMOTE-CRBehavioural
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.
ControlOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: REMOTE-CR |
| 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). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in submaximal aerobic exercise capacity
The aerobic exercise capacity (W) will be evaluated using a standardised submaximal exercise test on cycle ergometer
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Muscle endurance capacity
Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift
Measured: Baseline and 12 weeks
Isometric grip strength
Isometric grip strength will be evaluated using a hydraulic hand dynamometer
Measured: Baseline and 12 weeks
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
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start3 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Sandberg, Umeå University
- Investigators
- Camilla Sandberg, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479957
- Sponsor's protocol ID
- RemoteCR SWE
- Acronym
- RECREATION
- Status last verified
- May 2023
- First submitted
- 15 Mar 2018
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l
- ClinicalTrials.gov ID
- NCT03479957
- Acronym / sponsor ID
- RECREATION / RemoteCR SWE
- Conditions
- Heart Defects, Congenital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 3 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMOTE-CR | Experimental | Behavioral: REMOTE-CRRemotely 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 | Other | Other: ControlThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Clinically unstable
- Postoperative infection
- Comorbidity affecting ability to participate in exCR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMOTE-CRThe 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. | Behavioural | REMOTE-CR |
| ControlThe 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 | Usual care |
Primary outcome
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
5 secondary outcomes
Muscle endurance capacity
Time frame: Baseline and 12 weeks
Isometric grip strength
Time frame: Baseline and 12 weeks
Self-reported physical activity using theInternational Physical Activity Questionnaire
Time frame: Baseline and 12 weeks
Self-reported physical activity using the physical activity scale br Frändin and Grimby
Time frame: Baseline and 12 weeks
Kinesiophobia (fear of movement)
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for Heart Defects, Congenital
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Cronesten, RPT contact
Camilla Sandberg, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMOTE-CR in people with Heart Defects, Congenital, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Sandberg, PhD (+46907858441, camilla.sandberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in submaximal aerobic exercise capacity (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.