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Physical FitnessVAPA-OuluNCT03704025

Home-based Exercise Training in Cardiac Patients

A study testing Current guidelines rehabilitation and Mobile device guided rehabilitation in people with Physical Fitness and Patient Adherence, run by University of Oulu at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators hypothesize that exercise training program guided by virtual augmented reality glasses or by video from computer screen used at home will improve motivation into exercise training and results in superior adherence to exercise training compared to current practice. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Current guidelines rehabilitation and Mobile device guided rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFinland
Study dates
3 Jan 2018to 5 Jan 2021
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recent (< 1 month) acute coronary syndrome

Who cannot join

  • New York Heart Association (NYHA) functional classification class IV (heart failure)
  • unstable chest pain (angina pectoris, Canadian Cardiovascular Society grading of angina pectoris class 4)
  • ST-segment elevation myocardial infarction (STEMI)
  • implanted cardioverter defibrillation or pacemaker (or planned)
  • chronic atrial fibrillation
  • musculoskeletal disorder (unable to participate exercise training)
Show all 11Show fewer
  • participation in competing clinical trial
  • severe peripheral atherosclerosis
  • retinopathy or neuropathy
  • dementia
  • life-expectancy due to other serious disease < 2 years or any other reason why patient is unable or unwilling to provide written informed consent.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • University of Oulu

    Oulu, 90014

Other trials in Finland

About this study

Official title: Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients

The investigators hypothesize that exercise training program guided by virtual augmented reality glasses or by video from computer screen used at home will improve motivation into exercise training and results in superior adherence to exercise training compared to current practice. The primary objectives of this research project are to study the effects of exercise training guidance by novel technology on 1) exercise capacity, 2) adherence to exercise training, 3) changes in cardiac autonomic function and 4) quality of life in acute coronary syndrome (ACS) patients.

Read the detailed description

The subjects of the study will be recruited from the consecutive series of patients of men and women admitted to Oulu University Hospital due to an acute coronary syndrome (ACS). The study population will be randomized into control group (n=25) and study group (n=25) matched with age and gender. For all subjects, clinical status including quality of life questionnaire, exercise capacity and autonomic function measurements will be performed at baseline and after exercise training. Exercise training program is six months for both groups according to current guidelines. All the patients will have a detailed and personalized training prescription. Study group will have virtual augmented reality glasses or computer with training video to motivate and control exercise training prescription at home.

Being tested
Current guidelines rehabilitation, Mobile device guided rehabilitation
Keywords
Exercise tolerance, Heart rate variability, Baroreflex sensitivity
Medical subject headings
Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Current guidelines rehabilitationBehavioural

    Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. All the patients will have a detailed and personalized training diary.

  • Mobile device guided rehabilitationBehavioural

    Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. Study group will have virtual glasses or mobile device to motivate and control exercise training program.

Study groups in NCT03704025
Study groupRoleWhat they receive
Current guidelines rehabilitationActive comparatorExercise rehabilitation at home according to current guidelines. Training is guided and controlled by diary.
Receives: Behavioral: Current guidelines rehabilitation
Mobile device guided rehabilitationExperimentalExercise rehabilitation at home according to current guidelines. Training is guided and controlled by virtual augmented reality glasses or by mobile device.
Receives: Behavioral: Mobile device guided rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in exercise capacity

    Change in maximal load during exercise stress test (metabolic equivalents)

    Measured: Six months (baseline and 6 months)

Secondary outcomes (8)

  1. Adherence to exercise rehabilitation

    Realized training in relation to prescribed training over six months

    Measured: Weekly from baseline to six months

  2. Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability

    Change in 24 h SDNN (ms)

    Measured: Six months (baseline and 6 months)

  3. Change in very low frequency (VLF) of heart rate variability

    Change in 24 h VLF (ms^2)

    Measured: Six months (baseline and 6 months)

  4. Change in low frequency (LF) of heart rate variability

    Change in 24 h LF (ms^2)

    Measured: Six months (baseline and 6 months)

  5. Change in high frequency (HF) of heart rate variability

    Change in 24 h HF (ms^2)

    Measured: Six months (baseline and 6 months)

  6. Change in fractal scaling exponent of heart rate variability

    Change in 24 h Fractal scaling exponent (a.u.)

    Measured: Six months (baseline and 6 months)

  7. Change in baroreflex sensitivity

    Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg)

    Measured: Six months (baseline and 6 months)

  8. Change in quality of life

    Change in quality of life measured by 15-D questionaire

    Measured: Six months (baseline and 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2018
  2. Study start3 Jan 2018
  3. Primary completion5 Jan 2021
  4. Study completion5 Jan 2021

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03704025
Sponsor's protocol ID
281/2016
Acronym
VAPA-Oulu
Status last verified
Jan 2022
First submitted
1 Jun 2018
Last updated
6 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roiha E, Perkiomaki J, Kiviniemi AM, Junttila J, Huikuri HV, Tulppo MP. Individual exercise training response and ECG morphology in patients after an acute coronary syndrome. Physiol Rep. 2025 Dec;13(23):e70687. doi: 10.14814/phy2.70687.

    PubMed 41335527

  • Saarikoski EO, Roiha ETM, Kiviniemi AM, Cerdan-De-Las-Heras J, Perkiomaki J, Kaikkonen KS, Tulppo MP. Adherence to exercise after an acute coronary syndrome: a 6-month randomized controlled trial. Front Physiol. 2024 Jan 26;15:1319907. doi: 10.3389/fphys.2024.1319907. eCollection 2024.

    PubMed 38343424

  • Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.

    PubMed 34741536

Questions about this trial

What is this clinical trial studying?

A study testing Current guidelines rehabilitation and Mobile device guided rehabilitation in people with Physical Fitness and Patient Adherence, run by University of Oulu at 1 site in Finland.

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 1 inclusion and 11 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: finished, as of the sponsor's last update on 6 Jan 2022. 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 Finland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in exercise capacity (time frame: Six months (baseline and 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03704025, which also lists 3 linked publications.

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 6 Jan 2022.

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