Use of E-health Based Exercise Intervention After COVID-19

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05770505
Collaborator
University of Oslo (Other)
40
1
2
18
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise training using an e-health tool
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect E-health Based Exercise Intervention After COVID-19
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supervised exercise

Behavioral: Exercise training using an e-health tool
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

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Estimated cardiorespiratory fitness [After 6 months intervention]

    Estimated peak oxygen uptake

  2. Feasibilty [After 6 months intervention]

    Measured as acceptability and adherence

Secondary Outcome Measures

  1. Lung function [After 6 months intervention]

    Spirometry

  2. Sleep quality [After 6 months intervention]

    objective measures of sleep quality

  3. Quality of life [After 6 months intervention]

    Questionaires (SF-12)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging, Trondheim Norway 7006

Sponsors and Collaborators

  • Norwegian University of Science and Technology
  • University of Oslo

Investigators

  • Principal Investigator: Dorthe Stensvold Stensvold, Dorthe Stensvold, Professor, NTNU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05770505
Other Study ID Numbers:
  • 479316
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023