Back to resultsHome-based Exercise in COVID-19 Survivors
Primary Purpose
Covid19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with COVID-19
- Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
- Admitted in intensive care unit
Exclusion Criteria:
- Cardiovascular disease
- Resting dyspnea
- Acute pulmonary embolism or pulmonary infarction
- Deep venous thromboembolism
- Uncontrolled visual or vestibular disorders
- Pregnancy
- Uncontrolled resting tachycardia
- Uncontrolled hypertension
- Uncontrolled Type II diabetes
- Acute infections
- Neurological disorders
- Patients with chronic kidney disease who are in need of hemodialysis
- Recent malignant neoplasm (<5 years)
- Autoimmune diseases
- Complex ventricular arrhythmias, atrial fibrillation or complete heart block
- Transplant patients
- Any physical disabilities that could hamper physical testing and exercise program
Sites / Locations
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control group
Arm Description
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.
Outcomes
Primary Outcome Measures
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Higher score means better outcome.
Secondary Outcome Measures
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Higher score means worse outcome.
Change from baseline on lipid profile at 16 weeks.
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Change from baseline on insulin sensitivity at 16 weeks.
Fasting serum concentrations of glucose and insulin.
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Change from baseline on C-reactive Protein at 16 weeks.
Change from baseline on Creatine Kinase at 16 weeks.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Change from baseline on waist circumference at 16 weeks.
Change from baseline on hip circumference at 16 weeks.
Change from baseline on body weight at 16 weeks.
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Higher score means worse outcome.
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Higher score means worse outcome.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Higher score means worse outcome.
Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Higher score means worse outcome.
Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Higher score means better outcome.
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Higher score means worse outcome.
Change from baseline on fatigue assessed by Chalder scale at one year.
Higher score means worse outcome.
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Higher score means worse outcome.
Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Change from baseline on muscular strength assessed by handgrip test at one year.
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Full Information
NCT ID
NCT04615052
First Posted
October 29, 2020
Last Updated
June 10, 2022
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04615052
Brief Title
Home-based Exercise in COVID-19 Survivors
Official Title
Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
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
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.
Primary Outcome Measure Information:
Title
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
Description
Higher score means better outcome.
Time Frame
Baseline and 16 weeks.
Secondary Outcome Measure Information:
Title
Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on lipid profile at 16 weeks.
Description
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on insulin sensitivity at 16 weeks.
Description
Fasting serum concentrations of glucose and insulin.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on C-reactive Protein at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on Creatine Kinase at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on waist circumference at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on hip circumference at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on body weight at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
Time Frame
Baseline and 16 weeks.
Title
Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
Description
Higher score means better outcome.
Time Frame
Baseline and one year.
Title
Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
Description
Higher score means worse outcome.
Time Frame
Baseline and one year.
Title
Change from baseline on fatigue assessed by Chalder scale at one year.
Description
Higher score means worse outcome.
Time Frame
Baseline and one year.
Title
Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
Description
Higher score means worse outcome.
Time Frame
Baseline and one year.
Title
Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
Time Frame
Baseline and one year.
Title
Change from baseline on muscular function assessed by Timed-Stand Test at one year.
Time Frame
Baseline and one year.
Title
Change from baseline on muscular strength assessed by handgrip test at one year.
Time Frame
Baseline and one year.
Title
Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
Time Frame
Baseline and one year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with COVID-19
Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
Admitted in intensive care unit
Exclusion Criteria:
Cardiovascular disease
Resting dyspnea
Acute pulmonary embolism or pulmonary infarction
Deep venous thromboembolism
Uncontrolled visual or vestibular disorders
Pregnancy
Uncontrolled resting tachycardia
Uncontrolled hypertension
Uncontrolled Type II diabetes
Acute infections
Neurological disorders
Patients with chronic kidney disease who are in need of hemodialysis
Recent malignant neoplasm (<5 years)
Autoimmune diseases
Complex ventricular arrhythmias, atrial fibrillation or complete heart block
Transplant patients
Any physical disabilities that could hamper physical testing and exercise program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Gualano, PhD
Phone
55112661
Ext
8021
Email
gualano@usp.br
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, Phd
Phone
551130918783
Email
gualano@usp.br
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, Phd
12. IPD Sharing Statement
Learn more about this trial
Home-based Exercise in COVID-19 Survivors
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