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OpenTrials
Completed

NCT Number: NCT05697120

Long-term Effects of Individualized Follow-up With an App for One Year

The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR.

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Key information

Age range

41 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo Metropolitan University

Oslo, Norway

About this study

Recently, our research group demonstrated that individualized follow-up with an app for one year post-Cardiac Rehabilitation (post-CR) significantly improved exercise capacity, exercise habits and self-perceived goal achievement compared to a control group receiving usual care. To prepare for real-world implementation of an app to promote healthy behaviour post-CR, we will investigate the long-term effects (3-5 year post intervention). The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR. We hypothesize that patients allocated to the intervention group post-CR have internalized healthy behaviour and therefore have significantly higher exercise capacity and lower bodyweight compared to the control group, 3-5year post intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Included in the RCT of which this study is built on

Treatment and study plan

Primary outcomes

  1. Peak oxygen uptake

    Time frame: 5 year post rehab

    Relative VO2peak (ml/kg/min)

Secondary outcomes

  1. Time to exhaustion

    Time frame: 5 year post rehab

    Time on treadmill measured in seconds

  2. Peak incline

    Time frame: 5 year post rehab

    Incline (%) at treadmill in the end of the test

  3. Peak velocity

    Time frame: 5 year post rehab

    Kilometer per hour in the end of the test

  4. Bodyweight

    Time frame: 5 year post rehab

    Kilograms

  5. LDL cholesterol

    Time frame: 5 year post rehab

    Blood sample

  6. HDL cholesterol

    Time frame: 5 year post rehab

    Blood sample

  7. Total cholesterol

    Time frame: 5 year post rehab

    Blood sample

  8. Exercise habits

    Time frame: 5 year post rehab

    Mean number of exercise sessions each week for the last year

  9. Health related quality of life

    Time frame: 5 year post rehab

    HeartQoL

  10. Health status

    Time frame: 5 year post rehab

    EQ5D

  11. Cardiovascular events

    Time frame: 5 year post rehab

    Number of new cardiovascular events in the last five years

  12. Dietary habits

    Time frame: 5 year post rehab

    "Hva spiser du" - a norwegian questionnaire developed to assess nutrional habits

  13. Triglycerides

    Time frame: 5 year post rehab

    Bloodsample

  14. Physical activity

    Time frame: 5 year post rehab

    IPAQ

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Registry information

Official study title

Effect of Using a Smartphone Application to Promote Adherence to Healthy Behaviour Post-cardiac Rehabilitation: Five Year Follow-up of a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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