Back to resultsUse of E-health Based Exercise Intervention After COVID-19
Primary Purpose
COVID-19
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise training using an e-health tool
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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).
Sites / Locations
- Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supervised exercise
Control group
Arm Description
Outcomes
Primary Outcome Measures
Estimated cardiorespiratory fitness
Estimated peak oxygen uptake
Feasibilty
Measured as acceptability and adherence
Secondary Outcome Measures
Lung function
Spirometry
Sleep quality
objective measures of sleep quality
Quality of life
Questionaires (SF-12)
Full Information
NCT ID
NCT05770505
First Posted
March 13, 2023
Last Updated
March 13, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT05770505
Brief Title
Use of E-health Based Exercise Intervention After COVID-19
Official Title
Effect E-health Based Exercise Intervention After COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 COVID19.
Detailed 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 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 e-Health system to recruit, train and monitor participants after illness are needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise training using an e-health tool
Intervention Description
Experimental: Exercise training will be guided by suing the e-health tool MIA with the possibility for communication and messages between the participant and study personnel The participants will wearables that record heart rate. Participants will be encourage to achieve at least 100 Personal Activity Intelligence (PAI) equivalents per week Control: No follow-up
Primary Outcome Measure Information:
Title
Estimated cardiorespiratory fitness
Description
Estimated peak oxygen uptake
Time Frame
After 6 months intervention
Title
Feasibilty
Description
Measured as acceptability and adherence
Time Frame
After 6 months intervention
Secondary Outcome Measure Information:
Title
Lung function
Description
Spirometry
Time Frame
After 6 months intervention
Title
Sleep quality
Description
objective measures of sleep quality
Time Frame
After 6 months intervention
Title
Quality of life
Description
Questionaires (SF-12)
Time Frame
After 6 months intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorthe Stensvold Stensvold
Phone
+4792092856
Email
dorthe.stensvold@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorthe Stensvold Stensvold
Organizational Affiliation
Dorthe Stensvold, Professor, NTNU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorthe Stensvold
Phone
+47 72828092
Email
dorthe.stensvold@ntnu.no
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Use of E-health Based Exercise Intervention After COVID-19
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