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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05770505
Other study ID # 479316
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 17, 2023
Est. completion date December 2024

Study information

Verified date February 2024
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Reduced subjective and objective functional capacity performance are reported after COVID-19 in a large proportion of subjects. The aim of this study is to examine the feasibility and effect of using an e-health tool for guidance and tracking of exercise training in a general population of adults previously infected by COVID-19.


Description:

Both hospitalized and non-hospitalized persons who have undergone extensive multi-disciplinary rehabilitation programs report significantly improved physical function after rehabilitation. Exercise training may be the key intervention to improve fitness and subjective complaints such as fatigue, low physical fitness and dyspnea after COVID-19 infection. However, traditional group-based exercise training or self-training programs at fitness centers have been shut down during the pandemic, and home-based interventions are warranted. To overcome the limitations and costs of a fitness center/personal trainer-based intervention study, more knowledge on the effectiveness and efficacy of using an e-Health system to recruit, train and monitor participants after illness are needed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 77
Est. completion date December 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - Persons who have undergone COVID-19 disease - People who struggle to be physically active enough as a result of corona disease - People who experience reduced physical fitness as a result of corona disease Exclusion Criteria: -- more than 100 PAI per week (calculated from self-reported activity level) - uncontrolled hypertension (high blood pressure) (over 200/110). - symptomatic valve failure, hypertrophic cardiomyopathy, unstable angina, pulmonary - hypertension, heart failure and/or severe rhythm disturbances - cancer that makes participation impossible or exercise contraindicated. Considered individually in consultation with the attending physician. - chronic contagious infectious diseases. - Participates in other studies that are not compatible with participation in this project - Post-exertional symptom exacerbation (PESE)/post-exertional malaise (PEM)/post-exertional neuroimmune exhaustion (PENE).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise training using an e-health tool
Experimental: Exercise training will be guided by using the e-health tool MIA Health, with the possibility for digital communication between the participants and study personnel The participants will receive wearables that record heart rate. Participants will be encouraged to achieve 100 Personal Activity Intelligence (PAI) equivalents per week Control: No follow-up

Locations

Country Name City State
Norway Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging, Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory fitness Peak oxygen uptake After 6 months intervention
Primary Feasibilty Measured as acceptability and adherence After 6 months intervention
Secondary Lung function Spirometry After 6 months intervention
Secondary Quality of life Questionnaires (RAND-12) After 6 months intervention
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