Back to resultsHome-based Exercise Program in Patients With the Post-COVID-19 Condition
Primary Purpose
Long COVID, Post-acute COVID-19 Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Home-based physical training
Sponsored by
About this trial
This is an interventional treatment trial for Long COVID focused on measuring Exercise, Telemedicine, Long COVID
Eligibility Criteria
Inclusion Criteria:
- COVID-19 diagnostic history confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) or rapid antigen test (with clinical presentations of moderate to critical severity).
- Diagnosis of post-COVID-19 condition according to World Health Organization criteria.
- Present ≥1 symptoms at study admission, including dyspnea, fatigue, muscle weakness and/or musculoskeletal pain.
- Have internet access at home.
Exclusion Criteria:
- Being under clinical or experimental treatment for the post-COVID-19 condition.
- Any physical disabilities that could hamper physical testing and exercise program.
- Patients with major neuropsychiatric disorders (eg, dementia or severe depression).
- Patients with chronic kidney disease who are in need of hemodialysis.
- Solid organ transplant patients.
- Complex ventricular arrhythmias, atrial fibrillation or complete heart block.
- Recent malignant neoplasm.
- Recent deep venous thromboembolism.
- Acute pulmonary embolism or pulmonary infarction.
- Uncontrolled hypertension.
- Uncontrolled type II diabetes.
- Uncontrolled vestibular disorders.
- Acute infections.
- Pregnancy.
Sites / Locations
- University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical training group
Control group
Arm Description
In addition to receive regular medical care, the physical training group will participate in a tailored home-based exercise program (remotely supervised by healthcare professionals).
The control group will receive regular medical care.
Outcomes
Primary Outcome Measures
Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
Higher score means better outcome.
Secondary Outcome Measures
Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.
Higher score means better outcome.
Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.
Higher score means better outcome.
Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.
Higher score means better outcome.
Change from baseline in muscle function (number of repetitions) assessed by the 1-minute sit-to-stand test (1'STST) at 16 weeks.
Higher score means better outcome.
Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.
Higher score means worse outcome.
Change from baseline in functional capacity (from 0 to 4 degrees of functional limitation) assessed by the post-COVID-19 functional status (PCFS) scale at 16 weeks.
Higher score means worse outcome.
Change from baseline in physical activity levels (min/week of MVPA) assessed by the international physical activity questionnaires (IPAQ) at 16 weeks.
Higher score means better outcome.
Change from baseline in fatigue levels (from 0 to 33 points) assessed by the Chalder fatigue scale (CFQ) at 16 weeks.
Higher score means worse outcome.
Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.
Higher score means better outcome.
Change from baseline in learning and memory (z-score) assessed in a battery of cognitive tests at 16 weeks.
Higher score means better outcome.
Change from baseline in total body weight (kg) at 16 weeks.
Higher score means worse outcome.
Change from baseline in waist circumference (cm) at 16 weeks.
Higher score means worse outcome.
Change from baseline in hip circumference (cm) at 16 weeks.
Higher score means worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05360563
Brief Title
Home-based Exercise Program in Patients With the Post-COVID-19 Condition
Official Title
Effects of a Home-based Exercise Program on the Functional Sequelae of Patients With the Post-COVID-19 Condition: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (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 management of the sequelae of COVID-19 is described as the next great challenge of global public health. Multiple symptoms may compose the clinical picture of these patients (eg, fatigue, dyspnea, cognitive dysfunction, myalgia and others), persisting for more than a year and frequently causing clinically important functional impairment. Thus, a clinical trial will be conducted to investigate the effects of a remotely supervised home-based exercise program on functional sequelae of patients diagnosed with the post-COVID-19 condition (also known as Long COVID).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID, Post-acute COVID-19 Syndrome
Keywords
Exercise, Telemedicine, Long COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical training group
Arm Type
Experimental
Arm Description
In addition to receive regular medical care, the physical training group will participate in a tailored home-based exercise program (remotely supervised by healthcare professionals).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive regular medical care.
Intervention Type
Other
Intervention Name(s)
Home-based physical training
Intervention Description
Patients allocated to this group will participate in a 16-week home-based physical training program, structured in three weekly sessions of aerobic and muscle strengthening exercises (which also have components that stimulate flexibility and balance). A third of the weekly physical training sessions will be supervised via telemedicine (with video call) by a clinical exercise specialist, but all patients will have illustrated exercise booklets and a full-time remote support service available for the remaining sessions (via text or voice messages).
Primary Outcome Measure Information:
Title
Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in muscle function (number of repetitions) assessed by the 1-minute sit-to-stand test (1'STST) at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in functional capacity (from 0 to 4 degrees of functional limitation) assessed by the post-COVID-19 functional status (PCFS) scale at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in physical activity levels (min/week of MVPA) assessed by the international physical activity questionnaires (IPAQ) at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in fatigue levels (from 0 to 33 points) assessed by the Chalder fatigue scale (CFQ) at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in learning and memory (z-score) assessed in a battery of cognitive tests at 16 weeks.
Description
Higher score means better outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in total body weight (kg) at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in waist circumference (cm) at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
At baseline and after 16 weeks
Title
Change from baseline in hip circumference (cm) at 16 weeks.
Description
Higher score means worse outcome.
Time Frame
At baseline and after 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COVID-19 diagnostic history confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) or rapid antigen test (with clinical presentations of moderate to critical severity).
Diagnosis of post-COVID-19 condition according to World Health Organization criteria.
Present ≥1 symptoms at study admission, including dyspnea, fatigue, muscle weakness and/or musculoskeletal pain.
Have internet access at home.
Exclusion Criteria:
Being under clinical or experimental treatment for the post-COVID-19 condition.
Any physical disabilities that could hamper physical testing and exercise program.
Patients with major neuropsychiatric disorders (eg, dementia or severe depression).
Patients with chronic kidney disease who are in need of hemodialysis.
Solid organ transplant patients.
Complex ventricular arrhythmias, atrial fibrillation or complete heart block.
Recent malignant neoplasm.
Recent deep venous thromboembolism.
Acute pulmonary embolism or pulmonary infarction.
Uncontrolled hypertension.
Uncontrolled type II diabetes.
Uncontrolled vestibular disorders.
Acute infections.
Pregnancy.
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
05403-010
Country
Brazil
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
First Name & Middle Initial & Last Name & Degree
Jhonnatan Santos, MS
12. IPD Sharing Statement
Learn more about this trial
Home-based Exercise Program in Patients With the Post-COVID-19 Condition
We'll reach out to this number within 24 hrs